X
OK Your changes have been successfully saved
SFDA Home Page
Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
Competent Authorities Composite Listing
U.S FDA
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 027 06 23 000SIEMENSLuminos Agile Max.
Luminos dRF Max
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=199944
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=199947
mdprc 021 05 23 000DermLite LLCDERMLITE DL4Whttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=199376
mdprc 039 12 22 000Hill Rom IncHill-Rom Progressa Bed SystemFDA
mdprc 021 09 22 001Philips HealthcareDigitalDiagnost C50 1.1 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=195576
mdprc 019 09 22 000ICU Medical, Inc.MicroClavehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=195578
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=195579
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=195572
http://www.accessda
mdprc 017 09 22 000ICU Medical, IncChemoLock Closed System Drug Transfer Devicehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=195731
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=195036
mdprc 021 06 22 001Instrumentation Laboratory SpA, a Werfen CompanyACL TOP 300 CTS, ACL TOP 350 CTS, ACL TOP 500 CTS, ACL TOP 550 CTS, and ACL TOP 970 CLFDA, NCMDR
mdprc 011 07 22 000Diagnos Inc.CARA (Computer Assisted Retinal Analysis)https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=192285
mdprc 019 05 22 000SIEMENSSOMATOM with software syngo CT VA30A_SP4https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=192851
mdprc 039 03 22 000Bio-Rad Laboratories IncBioPlex 2200 SYPH T PACK Syphilis Total & RPR Reagent Pack & BioPlex 2200 Syphilis Total & RPR Calibrator Set CALhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=192210
mdprc 021 03 22 000Smiths Medical International Limited.Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe Infusion Pumpshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=190636
mdprc 006 03 22 000Hill Rom IncNaviCare and Voalte Nurse Call Systemshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=189999
mdprc 026 12 21 000Wright Medical Technology, Inc.Stryker CLAW II ORTHOLOC and Stryker DARCO Screwhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=190461
mdprc 019 11 21 000Hitachi Ltd.Arietta 850 Ultrasound; Lisendo 880 Ultrasoundhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=189705
mdprc 015 11 21 000Dentech Corp.Rubber Dam Clamp, KSKhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=187238
mdprc 022 09 21 000Siemens Healthcare Diagnostics, IncAtellica IM BR 27.29 (BR) Assay 250 Test KitUS. FDA
mdprc 009 09 21 000Hitachi Medical CorpECHELON MRI Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=188704
mdprc 033 08 21 000Pentax of America IncPentax Medical Video DuodenoscopeFDA
mdprc 007 08 21 000Sunrise MedicalZippie Voyagehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=188302
mdprc 001 08 21 000Siemens Healthcare DiagnosticsADVIA Chemistry XPT Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=187838
mdprc 003 07 21 000Quidel CorporationLyra SARSCoV2 Assay (M120) https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=187617
mdprc 033 06 21 000Fujifilm Medical Systems U.S.A., Inc.Synapse PACS - Radiological Image Processing Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=186333
mdprc 021 06 21 000Terumo Cardiovascular Systems CorporationSarns TCM II and TCM & Terumo HX2 Temperature Management SystemU.S. FDA
mdprc 019 10 20 001ESAOTE S.P.AAC/DC POWER SUPPLY for 7400NCMDR
mdprc 036 10 20 000Quidel CorporationSofia SARS Antigen FIA Package Inserthttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=183267
mdprc 034 10 20 000Gentian AS.Gentian Cystatin C Immunoassayhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=183752
mdprc 026 10 20 000Beckman CoulterUIBC System reagentU.S. FDA
mdprc 002 06 19 003Teleflex MedicalRUSCH LASERTUBE (Rubber)NCMDR
mdprc 095 01 18 001SybronEndo CorporationElements Obturation Unithttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160754
mdprc 028 09 20 000Siemens Medical SolutionsSymbia S-Series and Symbia T-Serieshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=183240
mdprc 025 06 20 000Philips HealthcarePhilips Sterilizable Defibrillator Internal Paddleshttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2020-RN-00367-1
mdprc 011 06 20 000The Magstim Company LimitedRapid2 and Horizon PSU Stim Interconnecting Cablehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=180785
mdprc 006 05 20 000Carl Zeiss - Micro Imaging MicroscopesComponent for Laser Scanning Microscopeshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=177441
mdprc 027 04 20 000MAQUET Cardiopulmonary GmbHAvalon Elite Vascular Access KitUS. FDA
mdprc 006 04 20 001DexCom IncDexcom G4 PLATINUM Continuous Glucose Monitoring System
Dexcom G5 Continuous Glucose Monitoring System
Dexcom G6 Continuous Glucose Monitoring System
NCMDR
mdprc 009 03 20 000BREAS Medical AB A GE Healthcare CoProtective Cover (Part No. 006344) for Vivo 50, Vivo 55, Vivo 60 and Vivo 65 ventilatorshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=179485
mdprc 010 02 20 000Palodex Group OyDIGORA Optime, GXPS500, KaVo Scan eXam and Instrumentarium Dental Express (FLAT PANEL/DIGITAL IMAGER)US. FDA
mdprc 040 12 19 000Zimmer, INC…Compress, Mini Compresshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=176438
mdprc 040 11 19 000Heritage Medical Products.2000 vascular with 30 degree optionhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174205
mdprc 029 11 19 000XODUS MEDICAL Inc.Cautery Tip Cleanerhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=176421
mdprc 022 11 19 000Life Technologies Limited.StemPro MSC SFM CTS, CTSTM Essential 8 Mediumhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174658
mdprc 008 10 19 000Roche Diagnostics CorpAccuChek Connect Apphttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175749
mdprc 006 10 19 000Medline Industries, Inc.Electrical surgical clipper and basehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=176259
mdprc 162 09 19 000Elekta Business Area Software Systems IMPAC Medical Systems Inc.Monaco RTP System.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=176158
mdprc 140 09 19 000Maquet Cardiovascular,LLC.HEMASHIELD PLATINUM Woven Double Velour Vascular Grafthttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=176040
mdprc 139 09 19 000Vital Scientific N.V.V-Twinhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175935
mdprc 138 09 19 000Arrow International IncArrow QuadLumen Central Venous Catheterization Kit, ARROWgard Blue PSI Kit CathGardhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175814
mdprc 124 09 19 000SENTINEL CH. SpAMultigent Lithium Assay, Alinity c Lithium Reagent Kithttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175596
mdprc 123 09 19 000Philips HealthcareIntelliVue 1.4 GHz Remote Antenna Used with Philips MX4O Monitorshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=176103
mdprc 122 09 19 000Philips HealthcareDigitalDiagnost C50https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=176038
mdprc 121 09 19 000Musculoskeletal Transplant Foundation, Inc..QuickGrafthttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=176019
mdprc 098 09 19 000MAQUET Cardiopulmonary GmbHHLS Set Advanced 7.0 Deviceshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174814
mdprc 097 09 19 000Ad-Tech Medical Instrument CorpADTECH Drill Sleeve Guideshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175964
mdprc 094 09 19 000Dynex Technologies LtdDynex DSX Instrumenthttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175187
mdprc 093 09 19 000ExactechThreaded Offset Cup Impactorhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175607
mdprc 092 09 19 000Teleflex Medical..Hudson RCI Sheridan LTShttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175293
mdprc 080 09 19 000Philips HealthcareHeartStart MRxhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175784
mdprc 079 09 19 000LeMaitre Vascular GmbHLemaitre Aortic Occlusion Catheterhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175640
mdprc 078 09 19 000Integra LifeSciencesIntegra Jarit Gemini Clamp 9 inchhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175161
mdprc 077 09 19 000Helena Biosciences Titan Gel Serum Protein Control (SPE Control)https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168437
mdprc 076 09 19 000Getinge Disinfection ABGetinge MCC Flow i Disposable CO2 absorberhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175330
mdprc 075 09 19 000FUJIFILM Medical SystemsFujifilm FDR Go Plus mobile Xray systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175614
mdprc 074 09 19 000Coltene Whaledent Inc.DIATECH, ROUND END TAPERhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175056
mdprc 073 09 19 000Becton Dickinson & Co. (BD)BD Kiestra InoqulA Software Version 20.3.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175594
mdprc 072 09 19 000AngioDynamics IncAngioDynamics VenaCure EVLT NeverTouch Procedure Kithttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174798
mdprc 071 09 19 000Karl Storz Endoscopy UK LtdIntubation Fiberscopehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175600
mdprc 041 09 19 000Medline Industries Inc.Medline Sterile Piston Irrigation Syringe Tray with Salinehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175718
mdprc 040 09 19 000Agilent Technologies..K6460 Triple Quadrupole MShttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173417
mdprc 039 09 19 000Leventon S. A. U.DOSIFUSERhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173331
mdprc 038 09 19 000Becton Dickinson & Co. (BD)CM Jamshidi Crown Bone Marrow biopsy/Aspiration Needle with MAChttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175641
mdprc 037 09 19 000Ad-Tech Medical Instrument CorpDepth Electrodeshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172558
mdprc 017 09 19 000Medline Industries, Inc.Primary Warmer Packs Containing Vyaire enFlow Disposable Cartridges .https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173166
mdprc 014 09 19 000Radiometer America IncABL90 FLEXhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174676
mdprc 013 09 19 000Luminex Molecular Diagnostics IncARIES System, ARIES M1 Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168673
mdprc 050 08 19 000Integra LifeSciencesCodman ISOCOOL Bipolar Forcepshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175411
mdprc 043 08 19 000Centurion Medical ProductsVarious Products: Speculum, vaginal, metal, Dressing tray, Circumcision trayhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174737
mdprc 042 08 19 000Ortho-Clinical DiagnosticsVITROS 250, 250AT, 350, 4600, 5600 and 5,1 FS chemistry systems. clinical chemistry analyzerhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174829
mdprc 041 08 19 000Ortho-Clinical DiagnosticsVITROS Chemistry Products GLU Slideshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174082
mdprc 040 08 19 000Ad-Tech Medical Instrument CorpLSB Style Anchor Bolthttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174373
mdprc 039 08 19 000Hycor Biomedical Inc.HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174649
mdprc 038 08 19 000DRG Instruments GmbHDRG Salivary Testosterone ELISAhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173940
mdprc 037 08 19 000Polymer Technology Systems, Inc.PTS Panels Lipid Panel test strip. Ref Number: 1710. Henry Schein Panels Lipid Panel test strip. Ref Number: 570-0414https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173514
mdprc 036 08 19 000Fresenius Medical Care.Liberty Cycler Cassetteshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173897
mdprc 035 08 19 000Howmedica Osteonics Corp.Serrato 9.5mm X 90mm Polyaxial Screw, Serrato 9.5mm X 100mm Polyaxial Screwhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174853
mdprc 005 08 19 000Terumo Medical Corp..Capiox NX19 Oxygenatorhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174208
mdprc 004 08 19 000Inovo, IncSingle Luman Conserverhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172722
mdprc 003 08 19 000Hycor Biomedical Inc.Autostat II Rheumatoid Factor IgM ELISAhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173183
mdprc 002 08 19 000Centurion Medical ProductsSheridan Endotracheal Tubehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174007
mdprc 001 08 19 000Alto Development CorpA&E Medical Corp. UltraFlexhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174555
mdprc 114 07 19 000GETINGE US SALES LLCPulsioFlex Monitorhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174106
mdprc 113 07 19 000Epimed International, Inc.Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm)https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174227
mdprc 112 07 19 000Encore Medical, LpDJO Surgicalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173392
mdprc 111 07 19 000CellEra LLCVITALE Silicon Foam Dressings 4"x4"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174543
mdprc 110 07 19 000Laborie Medical TechnologiesPower Supply Units Used with Solar Blue Urodynamic Systemshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174669
mdprc 109 07 19 000Wilson-Cook Medical, Inc.Acuject Variable Injection Needlehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173789
mdprc 108 07 19 000Bard Pcripheral Vascular (BPV)Powerport Cleavue Slim Implantable Porthttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171729
mdprc 107 07 19 000Teleflex Medical.Rusch EasyCath Kithttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174360
mdprc 106 07 19 000Ralston GroupMaximum Pelvic Trainerhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174733
mdprc 095 07 19 000Zyno Medical LLCAdministration Setshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173367
mdprc 094 07 19 000Merge Healthcare Corp.Merge PACS and Merge OrthoPACShttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174647
mdprc 093 07 19 000InfuTronix LLCNimbus Administration Sethttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173300
mdprc 078 07 19 000Stanley Healthcare SolutionsSTANLEY Healthcare Arial 54315 Network Manager environmental control, poweredhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174497
mdprc 065 07 19 000DeRoyal Industries Inc.CRANI PACKhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173848
mdprc 063 07 19 000Teleflex Medical..HUDSON RDI NEONATAL ConchaSmart Breathing Circuithttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173297
mdprc 062 07 19 000Cooper Surgical, Inc.Advincula Delineator Uterine Manipulators with Soft Koh-Efficient ,https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173714
mdprc 059 07 19 000Pharmaceutical Innovations, Inc.ElectroMisthttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174062
mdprc 058 07 19 000GE HealthcareUltrasound Probe RIC59D and Repair RIC59ARShttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=174509
mdprc 057 07 19 000Rinovum Women's HealthRevive Reusable Bladder Supporthttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173348
mdprc 056 07 19 000Boston ScientificBoston Scientific Extractor Pro RX-S Retrieval Balloon Catheterhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156048
mdprc 028 07 19 000Metrex Research, LLCRegimen 28 Day Glutaraldehyde Sterilizing and Disinfecting Solutionhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171828
mdprc 027 07 19 000Helena Biosciences EuropeColoCAREhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173480
mdprc 017 07 19 000Philips HealthcareVereos PET/CThttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173945
mdprc 016 07 19 000Infinium Medical, Inc.CLEO Patient Monitor /Tranquility VS Patient Monitorhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173303
mdprc 015 07 19 000Cardiac Science CorporationPowerheart G5 Automatic AEDhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173699
mdprc 014 07 19 000BaxterREVACLEAR 400, REVACLEAR 300 Dialyzerhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173325
mdprc 002 07 19 000johnson & johnson Surgical Vision Inc.Disposable 25GA Vitrectomy Cutter https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172948
mdprc 001 07 19 000HitachiPROBEAT-V https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173428
mdprc 099 06 19 000Medtronic Hancock II T510 Bioprosthesis, Mosaic 310 Bioprosthesis,https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173390
mdprc 081 06 19 000TecanFreedom EVO 200https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172787
mdprc 080 06 19 000Thermo FisherFisher Scientific Isotemp -General Purpose Water Bathhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173202
mdprc 075 06 19 000Zimmer, INC….The MobiC Cervical Disc Prosthesis (MobiC; MobiC 14mm Distraction Screwhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173314
mdprc 074 06 19 000Ethicon Inc.Ethicon ETHIBOND EXCEL Polyester Sutureshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=173104
mdprc 073 06 19 000CooperSurgical Inc..LEEP Precision Integrated Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172775
mdprc 072 06 19 000Skytron LLCSteam Sterilizerhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172192
mdprc 071 06 19 000Monarch Medical TechnologiesMonarch Medical Technologies EndoTool IVhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172822
mdprc 055 06 19 000ConforMISiTotal Hip Replacement System https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172560
mdprc 035 06 19 000Zimmer Biomet, Inc.Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172762
mdprc 034 06 19 000Terumo Medical Corp.Advanced Perfusion System 1 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172970
mdprc 030 06 19 000Zimmer Biomet, Inc.Lineum 4.35mm x 28mm Translation Screw https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172921
mdprc 029 06 19 000OMNIlife scienceOMNIBotics iBlock Cutting Guide https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172729
mdprc 028 06 19 000Centurion Medical ProductsSterile Nail Nipper https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172293
mdprc 021 06 19 000Smiths Medical JELCO Hypodermic Needle-Pro EDGE https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171714
mdprc 020 06 19 000NxStage Medical, Inc.NxStage PureFlow B Solution https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172387
mdprc 001 06 19 000Exatech inc.Opteform Allografthttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172638
mdprc 116 05 19 000Polymer Technology Systems, Inc…PTS Panelshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171371
mdprc 115 05 19 000OakworksOakworks Imaging Tableshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172888
mdprc 083 10 17 001CareFusion Alaris A BD CoAlaris Pump Module model 8100https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158454
mdprc 097 05 19 000Remel Inc.Thio Med w/o Ind, w/Dexhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172384
mdprc 096 05 19 000Neusoft Medical SystemsNeuViz 64 Multi-slice, 128 Multislice and 16 Essence Multislice CT Scanner System.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172628
mdprc 095 05 19 000Collagen Matrix, Inc. .Neomemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172146
mdprc 094 05 19 000KaVo Dental GmbHDEXIS Titanium Intraoral Sensorhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172388
mdprc 093 05 19 000Remel Inc.Thio Med w/Dex, Hem, Vit, K (7ml) and (5ml)https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172342
mdprc 087 05 19 000Cooper Surgical, Inc.ICSI MICROPIPETTEhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172286
mdprc 086 05 19 000Roche Diagnostics CorpCobas infinity central lab IT solutionhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171034
mdprc 085 05 19 000Compass Health BrandsMediPress Segmental Garmentshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172123
mdprc 084 05 19 000Integra LifeSciencesIntegra Flowable Wound Matrixhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172221
mdprc 083 05 19 000Stanley Healthcare SolutionsM200 Fall Monitoring Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168681
mdprc 082 05 19 000Terumo Medical Corp..Advanced Perfusion System 1_https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172129
mdprc 068 05 19 000PENTAX Europe GmbHPentax Medical C2 CryoBalloonhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171259
mdprc 067 05 19 000OpGen Inc.GNR PNA FISH Control Slide kit CS01110https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172289
mdprc 040 05 19 000Medica Corporation.Medica Wash1-Wash solution https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171152
mdprc 023 05 19 000Philips HealthcareFetal Spiral Electrodeshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171593
mdprc 022 05 19 000Molnlycke Health Care AB.EZ Derm Porcine Xenograftshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171757
mdprc 145 04 19 000Philips HealthcareIngenia Ambition S (781359), Ingenia Ambition X (781356) with Magnet Energization Device (MED),https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172033
mdprc 144 04 19 000Matrix Surgical Pty LtdOmniPore Surgical Implantshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171695
mdprc 143 04 19 000OssurMR-Conditional Halo System Deviceshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170606
mdprc 132 04 19 000KaVo Dental ORTHOPANTOMOGRAPH OP 3D CBCT xray systemshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170734
mdprc 131 04 19 000Fresenius Kabi LtdCATSmart device (Continuous autotransfusion System) https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171537
mdprc 130 04 19 000Exatech Truliant Tibial Fit Tray Cemented SZ 3F / 3T https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171680
mdprc 108 04 19 000ProSun International, LLCTanning bedhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171404
mdprc 105 04 19 000Integra LifeSciencesSalto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome Total Ankle Prosthesishttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171498
mdprc 095 04 19 000Encore Medical, LpExprt Precision Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171507
mdprc 094 04 19 000Ulrich GmbH & Co. KGULRICH Torque Limiting HandleTorque Wrenchhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171706
mdprc 093 04 19 000Roche Diagnostics CorpBilirubin Total Gen.3, Tina-quant IgM Gen.2 and Lactate Gen.2https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170149
mdprc 092 04 19 000Pintler Medical LLCHeated OR Torso pad of the Pintler Patient Warming Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171774
mdprc 035 04 16 001Philips HealthcareFoot Switches used with the Multiple systemshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171650
mdprc 091 04 19 000Philips BurtonAzurion FlexArmhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171662
mdprc 090 04 19 000Johnson & Johnson Vision CareACUVUE OASYS for ASTIGMATISMhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171551
mdprc 089 04 19 000Depuy Orthopaedics, IncCORAIL AMT STANDARD OFFSET NECK SEGMENT, CORAIL AMT HIGH OFFSET NECK SEGMENT and CORAIL AMT COXA VARA NECK SEGMENThttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171429
mdprc 088 04 19 000Becton Dickinson & Co. (BD)BD Gravity IV Sethttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171415
mdprc 087 04 19 000Beaver Visitec International LtdBeaver Xstar Slit Knife 2.4 mm, 45https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171509
mdprc 064 04 19 000ConforMISiTotal CR Total Knee Replacement System,https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170906
mdprc 060 04 19 000Zimmer, INC….Biomet RingLoc Hip System SelfTapping Bone Screwhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171366
mdprc 059 04 19 000LivaNova PLCSORIN Heater-Cooler System 3Thttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171458
mdprc 058 04 19 000Integra LimitedIntegra bioBLOCK Resorbable subtaler Implanthttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171442
mdprc 011 04 19 000Philips HealthcareLithium-ion Rechargeable Batteries for the Philips MX40 Wearable Monitorhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171236
mdprc 009 04 19 000Medical Action Industries IncLaparotomy Spongeshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171319
mdprc 006 04 19 000MAQUET Cardiovascular LLCCardiohelp Emergency Drivehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171237
mdprc 003 04 19 000ICU Medical, IncICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Porthttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169676
mdprc 002 04 19 000CryoLife, Inc.OnX Aortic Heart Valvehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170731
mdprc 001 04 19 000ConforMISiTotal Posterior Stabilized (PS) Knee Replacement System.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170909
mdprc 096 03 19 000Keystone Dental Inc.PalTophttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171470
mdprc 095 03 19 000Beaver Visitec International LtdBVI Visitec Soft Tip Cannulahttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169745
mdprc 094 03 19 000Accelerate Diagnostics IncAccelerate Pheno systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171153
mdprc 090 03 19 000Randox Laboratories Ltd.Randox Blood Gas Control Level 2https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171118
mdprc 089 03 19 000FenwalCATSmart Vacuum Pumphttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171116
mdprc 085 03 19 000Smith & Nephew incJOURNEY II XR TIBIAL POSTERIOR KEEL PUNCHhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169782
mdprc 084 03 19 000LW Scientific, Inc.LW Scientific ZIP IQ PCV Centrifugehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171148
mdprc 083 03 19 000ConvaTecNelaton Urinary Catheter, Feeding Tube Metric, FilterFlow Suction Handle CH24, Forceps Bluehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170714
mdprc 082 03 19 000Becton Dickinson & Co. (BD)BD Synapsys Microbiology Informatics Solutionhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171162
mdprc 081 03 19 000Avitus Orthopaedics, Inc.Avitushttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171254
mdprc 080 03 19 000ACell IncGentrix Thick Surgical Matriceshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171171
mdprc 070 03 19 000CP Medical IncPlain and Chromic Gut Absorbable Surgical Sutureshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171120
mdprc 025 03 19 000Reckitt Benckiser HealthcareDurex Pleasure Pack.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170511
mdprc 024 03 19 000MicrobiologicsCepheid Respiratory Control PanelQ.M.S. Co. Ltd https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170853
mdprc 023 03 19 000Linet spol. s r.o.AVE 2 Birthing Bedshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170332
mdprc 014 03 19 000Stryker Sustainability SolutionsStryker Sustainability Solutions (SSS)https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170821
mdprc 003 03 19 001Becton Dickinson & Co. (BD)Phoenix ASTs Indicatorhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00332-1
mdprc 002 03 19 000Zimmer, INC….Biomet Comprehensive Reverse Shoulderhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167479
mdprc 001 03 19 000PENTAX C2 CryoBalloon Ablation Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169563
mdprc 135 02 19 000Terumo Medical Corp..Terumo Cardiovascular Systemshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170572
mdprc 134 02 19 000Shimadzu Medical Systems.BRANSIST safirehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170523
mdprc 133 02 19 000BrosMed Medical Co.,Ltd.Hermes NC PTA Balloon Dilation Catheterhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170512
mdprc 132 02 19 000bioMerieux IncVitek 2https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170347
mdprc 131 02 19 000American Contract Systems, Inc.Surgical convenience kitshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169600
mdprc 130 02 19 000Abbott VascularPlus 30 PRIORITY PACK (Accessories Kits)https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170566
mdprc 129 02 19 000ExactechEquinoxe Preserve Humeral Stem, 8mmhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170578
mdprc 090 02 19 000Zimmer, INC….Vanguard Knee System Series-A Standard Patellahttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170553
mdprc 089 02 19 000ICU Medical, IncChemoLock Vial Spikeshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170359
mdprc 085 02 19 000BaxterKaguya Automated Peritoneal Dialysis Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169659
mdprc 073 02 19 000Teleflex Medical ,Pilling COOLEY SUMPSUCTION TUBEhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170297
mdprc 072 02 19 000Smiths Medical International LimitedPortex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin and Portex Pulsator Arterial Blood Sampling Kit with Liquid Sodium Heparinhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166689
mdprc 071 02 19 000Signature OrthopaedicsGenius Total Knee Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170488
mdprc 070 02 19 000Ortho-Clinical DiagnosticsVITROS Immunodiagnostic Products Myoglobin Calibratorshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169785
mdprc 069 02 19 000bioMerieux IncVITEK 2 ASTN351 Test Kithttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170402
mdprc 068 02 19 000AtriCureCOBRA FUSION 50 and 150 Ablation Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170344
mdprc 062 02 19 000STERIS Corporation.ATLAS Loading Carhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170576
mdprc 050 02 19 000West Pharma Services ILVial2Bag Direct Connect 13 mm IV Fluid Transfer Setshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170468
mdprc 045 02 19 000Argon Medical Devices IncBone marrow needlehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170494
mdprc 044 02 19 000Neusoft Medical SystemsNeuViz 128 Multislice CT Scanner Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170298
mdprc 023 11 18 001Roche Diagnostics CorpCoaguChek XS Test Strips INST 48CThttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170144
mdprc 042 01 19 001Arrow International IncArrow CVChttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169383
mdprc 016 02 19 000XTANT MEDICAL INCCalix Lumbar Spinal Implant Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170253
mdprc 005 02 19 000Roche Diagnostics CorpElecsys Anti HAV IgMhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170000
mdprc 084 01 19 001Cook Medical Europe Limited,Captura Serrated Large Forcephttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170186
mdprc 083 01 19 000LivaNova PLCPerfusion Tubing Systems Containing Stopcocks and Stopcock Manifolds.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169426
mdprc 078 01 19 002Stryker Sustainability SolutionsBW Lasso 2515 ANV eco Variable Diagnostic EP Catheterhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170204
mdprc 077 01 19 001LivaNova PLCPerfusion Tubing Systems Containing Stopcocks and Stopcock Manifolds.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169426
mdprc 067 01 19 000Kimberly Clark Health Care..U by Kotex Sleek Tamponshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169746
mdprc 066 01 19 000Fetzer Medical GmbH & Co. KGObstetric Forcepshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170175
mdprc 059 01 19 000DeRoyal Industries Inc.DeRoyal(R) Enteral Safe Feed Tube, REF 542465https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169992
mdprc 058 01 19 000Meridian Bioscience IncPREMIER Cryptococcal Antigen enzyme immunoassay (EIA)https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169846
mdprc 045 01 19 000Zimmer, INC….Biomet DVR Crosslock Screwshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169576
mdprc 044 01 19 000Smith & Nephew incSL PLUS MIA DOUBLE OFFSET ADAPTERhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170307
mdprc 043 01 19 000Canadian Hospital SpecialtiesMEDRX POLYURETHANE FEEDING TUBEhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169778
mdprc 041 01 19 000Cardinal-HealthPresource Kit Total Joint Packhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169742
mdprc 037 01 19 000SwissraySwissray ddRCombi Traumahttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169713
mdprc 012 01 19 000Ultradent products INC.Enamelast Cool Mint/OT Varnish 5 NaF Minthttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168643
mdprc 001 01 19 000Medtronic SAStealthStation Cranial and Synergy Cranial Depth Gaugehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167816
mdprc 126 12 18 000Randox Laboratories Ltd.Liquid Protein Calibratorshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169364
mdprc 125 12 18 000Tosoh CorporationTosoh AIA Packshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169033
mdprc 124 12 18 000KONICA MINOLTA, INCKDR UArm, Bucky and Tubestandhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169254
mdprc 123 12 18 000In2Bones, SASNeoSpan SuperElastic Compression Staple with Instrumentshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169279
mdprc 122 12 18 000Howmedica Osteonics Corp.HydroSet XT Injectable HA Bone Cementhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169172
mdprc 121 12 18 000Fresenius Medical Care.Optiflux F160NR Dialyzershttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169039
mdprc 120 12 18 000Bracco Injeneering S.A.Empower FastLoad CT Syringe Packhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169073
mdprc 113 12 18 000Theragenics CorporationTheragenics Brachytherapy needleshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168923
mdprc 112 12 18 000bioMerieux IncVITEK 2 & VITEK 2 Compacthttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169023
mdprc 111 12 18 000Advanced Instruments IncGloCyte Automated Cell Counter System, GloCyte Low and High Level Controlshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162695
mdprc 108 12 18 000Covidien LLC….Covidien Emprint Standard Percutaneous Antenna with Thermosphere Technologyhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169031
mdprc 107 12 18 000Bausch & Lomb GmbH..enVista One Piece Hydrophobic Acrylic Intraocular lenshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169043
mdprc 081 12 18 000Tosoh CorporationAIA2000 and AIA900 Analyzershttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167743
mdprc 080 12 18 000Tosoh CorporationAIA900 Automated Immunoassay Analyzer.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167650
mdprc 079 12 18 000Tosoh CorporationAIA360 Analyzerhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167620
mdprc 078 12 18 000Philips HealthcareXper Flex Cardio Patient Monitoring Systems (FC2010, FC2020)https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168911
mdprc 077 12 18 000Abbott Laboratories Inci-STAT CG8+ Cartridgeshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167569
mdprc 069 12 18 000AngioDynamics IncNavilyst Medical BioFlo PICC with ENDEXO and PASVhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168815
mdprc 058 12 18 000Philips HealthcareIntelliVue MX40 Patient Monitorhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168916
mdprc 054 12 18 000Zimmer, INC…. Comprehensive Mini Stem, Orthopedic Salvage System (OSS)https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168913
mdprc 053 12 18 000Tosoh CorporationAIA360https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167366
mdprc 052 12 18 000Leoni Fiber Optics GmbHLaser Fiber Assy-Single Usehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168872
mdprc 051 12 18 000Arjo IncFlite Clip Sling, 4 Pointhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168967
mdprc 030 12 18 000Pfizer LimitedVarious Thermacare Heat Wrapshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167683
mdprc 029 12 18 000Zimmer, INCBiomet 20mm Compress Device Short Anchor Plug With Drill Sethttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168863
mdprc 025 12 18 000Invacare CorporatioInvacare 9805 and 9805P Hydraulic Patient Liftshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167386
mdprc 013 12 18 000Becton Dickinson & Co. (BD)BD BBL Trypticase Soy Agar with 5 Sheep Blood, Catalog No. 221261https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168983
mdprc 012 12 18 000ASO, LLCFirst Aid Sterile Gauze Padhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168957
mdprc 008 12 18 000Tosoh CorporationAIA900 Automated Immunoassay Analyzerhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167811
mdprc 007 12 18 000PerkinElmer Life and Analytical SciencesQSight 210 MD Mass Spectrometer Simplicity 3Q MDhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167969
mdprc 006 12 18 000NuMED, Inc.MultiTrack Angiographic Catheter (MMTA)https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168770
mdprc 005 12 18 000Eurotrol B.VEurotrol HemoTrol Hemoglobin Controls..https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168810
mdprc 004 12 18 000W.O.M. World of Medicine GmbH .PNEUMOCLEARhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168818
mdprc 098 11 18 000Zimmer, INC….Vanguard Knee System PS Open Box Femoral Right and lefthttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168792
mdprc 097 11 18 000Becton Dickinson & Co. (BD) BD Vacutainer Urine Cupshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167544
mdprc 081 11 18 000GE HealthcareDeltaVision OMX SR Imaging Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168762
mdprc 080 11 18 000SVS LLCPremierPro Aluminum Adjustable Walkerhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168385
mdprc 079 11 18 000Tosoh CorporationTosoh AIA-900 immunoassay Analyzerhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167822
mdprc 069 11 18 000Zimmer, INC….The Affixus Hip Fracture Nail Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167854
mdprc 068 11 18 000VoluntisInsulia Diabetes Management Companionhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168856
mdprc 067 11 18 000Tosoh CorporationRecall AIA900 Analyzerhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167729
mdprc 066 11 18 000Tosoh CorporationAIA2000 AnalyzerFDA
mdprc 065 11 18 000StrykerReprocessed LASSO NAV eco Electrophysiology Catheterhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168248
mdprc 064 11 18 000Straumann Manufacturing, Inc.Endosseous dental implant abutmenthttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168765
mdprc 063 11 18 000Invivo CorporationXper Flex Cardio Physiomonitoring Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167437
mdprc 062 11 18 000Canon IncRadPRO Mobile 40kW Digital X-Ray Systemshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168732
mdprc 061 11 18 000American Contract Systems, Inc.Powdered Surgical Glvoeshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166267
mdprc 102 04 18 001Zimmer Biomet, Inc.Intramedullary FixationBfArM
mdprc 051 11 18 000Safe N Simple, LLCSimpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING ADHESIVE BORDERhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167530
mdprc 050 11 18 000Medtronic SAMedtronic Navigationhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168363
mdprc 049 11 18 000Integrity Implants Inc.FlareHawkhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167968
mdprc 048 11 18 000Fannin UK LtdEspiner Tissue Retrieval System..https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167206
mdprc 047 11 18 000BioFire Diagnostics IncBioFire FilmArray Meningitis/Encephalitis (ME) Panelhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167757
mdprc 046 11 18 000Arthrex Inc3.2mm Proximal Reamer/Cannulated Drillhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167480
mdprc 045 11 18 000Aroa BiosurgeryOviTex Reinforced BioScaffoldhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167628
mdprc 032 11 18 000Ortho-Clinical DiagnosticsVITROS Immunodiagnostic Products Vitamin B12 Reagent Packhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167380
mdprc 022 11 18 000GE HealthcareCentricity Universal Viewer with PACSIW foundation 6.0.x, entricity PACSIW with Universal Viewer version 5.0.x with PACSIW foundationhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168670
mdprc 021 11 18 000Fresenius Kabi LtdVolumat MC Agiliahttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167772
mdprc 020 11 18 000Coltene Whaledent Inc.ParaPost Plus Postshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167379
mdprc 019 11 18 000Aroa BiosurgeryEndoform Dermal Templatehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167603
mdprc 018 11 18 0003M Health Care Ltd3M Fast Release Varnishhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166237
mdprc 012 11 18 000Philips HealthcareVereos PET/CT, Software version 2.0.1.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167661
mdprc 006 11 18 000CMP Industries, LlcIMPAK ELASTIC ACRYLIC RESIN LIQUIDhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167770
mdprc 180 10 18 000Arrow International IncARROWgard Blue Plus MultiLumen CVC Kithttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167478
mdprc 179 10 18 000Custom Healthcare SystemCHS Custom Convenience Kithttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167781
mdprc 178 10 18 000Magellan Diagnostics IncLeadCare II Blood Lead Test Kithttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167389
mdprc 169 10 18 000GE HealthcareNuclear Magnetic Resonance Imaginghttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168339
mdprc 168 10 18 000Intuitive Surgical Incda Vinci Si Drapes and Disposable Accessory Kitshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167918
mdprc 167 10 18 000Micro-Tech (Nanjing) Co., LtdBiopsy Forcept (Alligator with Spike)https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167676
mdprc 166 10 18 000NakanishiSurgical Handpiecehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166437
mdprc 165 10 18 000Synthes GmbHDePuy Synthes 3.0mm Headless Compression Screwshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167574
mdprc 164 10 18 000bioMerieux IncNucliSENS Magnetic Extraction Reagentshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167420
mdprc 163 10 18 000Howmedica Osteonics Corp.Tritanium TL Steerable Inserterhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167441
mdprc 142 10 18 000Canon Europa N.V.Vantage Titan and Vantage Elan MRI Systemshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167258
mdprc 141 10 18 000Data InnovationsIM Abbott Alinity ciseries (abdicqii) accessory driverhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167216
mdprc 140 10 18 000Smith & Nephew incLEGION A/P FEMORAL CUTTING BLOCKhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167446
mdprc 129 10 18 000CryoLife, IncCryoPatch SG Pulmonary HemiArteryhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167440
mdprc 128 10 18 000GE HealthcareCentricity Universal Viewer 6.0https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168145
mdprc 127 10 18 000Medacta International SAMiniMAX CEMENTLESS ANATOMICAL STEMhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167435
mdprc 126 10 18 000OriGen BiomedicalOriGen Reinforced Dual Lumen Cannulahttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167041
mdprc 125 10 18 000Philips HealthcareHeartStart FR3 Defibrillatorhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167498
mdprc 124 10 18 000Shimadzu Medical SystemsTRINIAShttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167416
mdprc 123 10 18 000A M Systems IncDisposable Smooth Interior Tubinghttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167392
mdprc 122 10 18 000AS Software, Inc.ASOBGYN Information System version 7.824.xhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167364
mdprc 121 10 18 000Cypress Medical Products.McKesson Insulin Syringe 0.3mLhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167474
mdprc 120 10 18 000Life Technologies Limited.Gibcohttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167359
mdprc 118 10 18 000Mindray DS USA, Inc., dba Datascope Patient MonitoringMindray BeneVision Distributed Monitoring System (DMS)https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167424
mdprc 110 10 18 000BESMED HEALTH BUSINESS CORP.Ambu Aura40 Standardhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167221
mdprc 109 10 18 000Carl Zeiss Meditec IncCarl Ziess Meditec AG IOLMaster 700https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167198
mdprc 086 10 18 000Baxter HealthcareSPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWAREhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167598
mdprc 085 10 18 000Beckman CoulterAccess 2 Immunoassay Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146785
mdprc 084 10 18 000Cardiovascular Systems, IncDIAMONDBACK 360 Peripheral Orbital Atherectomy Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160822
mdprc 083 10 18 000ExactechTibial Alignment Guide.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166109
mdprc 082 10 18 000Helena Biosciences EuropeFree and Total Protein S ELISA Kithttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167256
mdprc 081 10 18 000OriGen BiomedicalReinforced Dual Lumen Cannula, VV13Fhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167443
mdprc 080 10 18 000Thoratec CorpThoratec CentriMag Motor, Model: 102956https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166940
mdprc 079 10 18 000Valeris Medical, LLCValeris Medical Apollo Medial Suture Anchorhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166244
mdprc 077 10 18 000Stryker Spine SAAVS Aria Cagehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167153
mdprc 076 10 18 000Widex A/SWIDEX BABY440https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167425
mdprc 055 10 18 000AngioDynamics IncBioFlo Port with ENDEXO and PASV Technologyhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166933
mdprc 054 10 18 000Implant Direct Sybron Manufacturing,LLCImplant Direct Legacy Implanthttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165075
mdprc 053 10 18 000Incisive Surgical IncINSORB SUBCUTICULAR SKIN STAPLER.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167220
mdprc 052 10 18 000Instrumentation Laboratory.HemosIL ReadiPlasTin.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167053
mdprc 051 10 18 000Medline Industries, Inc.Boot Compression Wraphttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167154
mdprc 050 10 18 000SterilmedReprocessed Agilis Steerable Introducerhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167197
mdprc 037 10 18 000Covidien LLCCovidien Kerlix AMD, Kerlix, and Dermacea Bandage and Gauze Rollshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166993
mdprc 036 10 18 000Vision RT LtdIntegrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant onlyhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167432
mdprc 035 10 18 000Beckman Coulter BECKMAN COULTER MicroScan MICroSTREP Plus Panel,MicroScan MuellerHinton Broth with 3 lysed horse bhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163468
mdprc 034 10 18 000Cincinnati Sub-Zero Products IncThe Hemotherm Dual Reservoir Cooler/Heaterhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167066
mdprc 033 10 18 000Ellex iScience, Inc.ellex I.Science iTRACK 250Ahttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165749
mdprc 032 10 18 000ExactechEquinoxe Reverse Drill Bit Kithttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167190
mdprc 012 10 18 000Rayner Intraocular Lenses LtdCflex Intraocular Lenshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167068
mdprc 011 10 18 000Intuitive Surgical Incda Vinci Si/X/Xi Surgical Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167074
mdprc 010 10 18 000Shockwave Medical, Inc.Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166759
mdprc 009 10 18 000SwissrayddR Formula B xray systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167341
mdprc 008 10 18 000Tosoh Bioscience IncG8 Analyzerhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165791
mdprc 007 10 18 000Ventana Medical SystemsImmunohistochemistry (IHC)https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166712
mdprc 006 10 18 000Zimmer Biomet, IncJuggerknot Long Flex Drill Bithttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166941
mdprc 005 10 18 000Zimmer, INCVanguard 360 Revision Knee Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166904
mdprc 122 09 18 000Accuray IncAshland(TM) Box Film Ball Cube II EBT3https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167054
mdprc 121 09 18 000ExactechOptetrak Logic CC Stem Extension, 22mm x 160mmhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166799
mdprc 120 09 18 000Medtronic Temperature sensor catheters https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166446
mdprc 119 09 18 000Reckitt Benckiser HealthcareDurex Real Feel Polyisoprene Condomshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166702
mdprc 118 09 18 000ShinChang Medical Co., LtdDisposable Insulin Syringe 0.3mLhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167073
mdprc 117 09 18 000Arrow International Inc.Bipolar Electrode Catheter with shrouded pins https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166781
mdprc 116 09 18 000Biocare Medical URO-3 Triple Stain (CD44 + p53) with CK20https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165380
mdprc 115 09 18 000Med-Mizer, Inc.PR1000 Pivot Rehab Bed AC powered adjustable bed.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166687
mdprc 114 09 18 000Medtronic Contour Plus Link 2.4 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166154
mdprc 113 09 18 000SwissrayddR Formula B X-ray Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167170
mdprc 111 09 18 000Beaver Visitec International LtdBeaver 2-Inch Shaft with Fine Tip Accu-Temp High-Temperature Cautery Deviceshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166710
mdprc 110 09 18 000MAKO Surgical CorpMakoplasty RIO Standard System https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166807
mdprc 109 09 18 000StrykerIsoFlex LAL Support Surfacehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166820
mdprc 108 09 18 000Zimmer Biomet, Inc.Gentle Thread PLGA Full Thread Interference Screw https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166705
mdprc 107 09 18 000Bayer Medical Care, Inc.Overhead Counterpoise Systems (OCS)https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166230
mdprc 106 09 18 000Cardiovascular Systems, Inc.Orbital Atherectomy System (OAS) Saline Infusion Pump https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166793
mdprc 105 09 18 000Hitachi VidiStar(TM) PACS & DICOM Viewer Software systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166868
mdprc 104 09 18 000Medline Industries Inc.PICC Tray, Art-Line Surgery Pack-LF, Laparoscopy CDS, Cardiac Insulation Pad and LASER CDShttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159473
mdprc 103 09 18 000NordicNeuroLab Inc.fMRI Hardware System VisualSystemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165672
mdprc 102 09 18 000Ohio Medical Corporationcare-e-vac 3 Battery and AC-Powered Portable Aspiratorshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166447
mdprc 101 09 18 000Remel Inc.THIOGLYCOLLATE MEDIUM https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166568
mdprc 100 09 18 000SPS Sterilization, Inc.Multiple Products http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=165305
mdprc 099 09 18 000Zimmer Biomet, Inc.Peg Fully Threadedhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166235
mdprc 098 09 18 000Vascular Technology, Inc.VTI 8 MHz Surgical Dopplerhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165673
mdprc 097 09 18 000Sysmex America Inc (N/A)Sysmex Fluorocell PLThttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166208
mdprc 096 09 18 000Medline Industries Inc.Medline 0.9 Sodium Chloride Injectionhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166187
mdprc 095 09 18 000DePuy International LimitedP.F.C. SIGMA Revision Knee System Distal Augmenthttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166108
mdprc 063 09 18 000C R Bard IncUrine Collection BARD Midstream Catch Kit with Funnel Connectorhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165908
mdprc 062 09 18 000Medtronic SATurboHawk Peripheral Plaque Excision Systemshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166684
mdprc 061 09 18 000Stanbio Laboratory, LPPower adapter for the HemoPoint H2 meter, Model G3000 serieshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165739
mdprc 014 09 18 000Arrow International IncARROW Pediatric TwoLumen Central Venous Catheterization Kit with Blue FlexTip ARROWgard Blue Cathehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165939
mdprc 013 09 18 000bioMerieux IncVITEK 2 Gram Positive, Cefoxitin Screen and AST for Oxacillinhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165899
mdprc 012 09 18 000Johnson & Johnson Vision CareJohnson and Johnson Vision Care 1 Day ACUVUE MOISThttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166086
mdprc 011 09 18 000Smith & Nephew incGENESIS II NONPOROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHThttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166265
mdprc 090 08 18 000Vyaire Medical, Inc..TriFlo Subglottic Suction Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165645
mdprc 089 08 18 000Ortho Kinematics, IncVertebral Motion Analyzerhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166147
mdprc 088 08 18 000LIEBEL-FLARSHEIM COMPANY LLCLiebelFlarsheim Hydra Vision Urology XRay System (DR)https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164768
mdprc 087 08 18 000In2Bones, SASCoLink(TM) Lapidus Plate XPhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165897
mdprc 086 08 18 000Back 2 Basics Direct LLCDymaxeon Spine Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165987
mdprc 085 08 18 000Compass Health BrandsCPAP Mask Cushionhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165713
mdprc 084 08 18 000Philips Healthcarephilips DigitalDiagnost 2.xhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165967
mdprc 083 08 18 000ICU Medical de Mexico, S.A.Ext Sethttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165537
mdprc 082 08 18 000Zimmer Biomet, Inc.ECHO BiMetric Hip Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165699
mdprc 081 08 18 000Zimmer Biomet, Inc.ECHO BiMetric and ARCOS Modular Revision Hip Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165699
mdprc 080 08 18 000Withings SasBlood Pressure Monitorhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165696
mdprc 079 08 18 000TriMed Ulnar Osteotomy Compression Plate, Shorthttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165588
mdprc 078 08 18 000Nico CorpNICO Shepherds Hook Greenberghttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165708
mdprc 077 08 18 000Hitachi America, Ltd.Hitachi Scenaria CT systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166120
mdprc 076 08 18 000DRG Instruments GmbHZ-2836-2018https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165759
mdprc 075 08 18 000Cypress Medical Products.McKesson Powder Free Vinyl Exam Gloveshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166117
mdprc 074 08 18 000bioMerieux IncbioMrieux VITEK 2 NH ID Test Kithttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165596
mdprc 073 08 18 000Becton Dickinson & Co. (BD)BD BBL GCLect Agarhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165757
mdprc 053 08 18 000Vitalgo IncVitalGo Total Lift Bedhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165601
mdprc 052 08 18 000Tosoh Bioscience IncG8 Automated HPLC Analyzerhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164973
mdprc 051 08 18 000Mevion Medical Systems, Inc.MEVION S250/MEVION S250ihttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165886
mdprc 050 08 18 000GUANGZHOU Wondfo Biotech Co., Ltd.TCube One Step MultiDrug Oral Fluid Test Cubehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165501
mdprc 049 08 18 000Cook EndoscopyVentriClearhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165597
mdprc 048 08 18 000Beaver Visitec International LtdBeaver Xstarhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165742
mdprc 047 08 18 000Water Pik, IncSonic-Fusion Flossing Toothbrusheshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165720
mdprc 046 08 18 000Spacelabs Healthcare IncArkon Anesthesia Delivery System..https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165550
mdprc 045 08 18 000Hudson Scientific LLCiTOVi Tracker/Scannerhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165574
mdprc 044 08 18 000Howmedica Osteonics Corp.rHead, Lateral Assembly and multiple Orthopedic implantshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161897
mdprc 043 08 18 000Boston Scientific Cardiac Rhythm Management GroupBoston Scientific Guider Softip XF Guide Catheterhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165651
mdprc 042 08 18 000Think Surgical, Inc.Think Surgical Cutterhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164544
mdprc 027 08 18 000Tandem Diabetes Care Inct:slim G4 Insulin Pump with Dexcom G4 Platinum CGMhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163813
mdprc 023 08 18 000Baxter AMIA Automated PD Cyclerhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165664
mdprc 022 08 18 000Encore Medical, LpInstrument trays used to store AltiVate Small Shell Trialshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165508
mdprc 021 08 18 000Medtronic SACD HORIZON Solera Spinal System Screwshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165709
mdprc 020 08 18 000New Era Orthopaedics, LLcModera Modular Pedicle Screw Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165627
mdprc 011 08 18 000Envoy Medical CorporationFinal Pack, Esteem II, Sound Processor Model 2001https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165600
mdprc 008 08 18 000Arrow International IncArrow Percutaneous Sheath Introducer Kithttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165304
mdprc 153 07 18 000Terumo Cardiovascular Systems CorporationCardiovascular Procedure Kithttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165032
mdprc 152 07 18 000LivaNova PLCVNS Therapy Programming Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165408
mdprc 150 07 18 000CryoLife, Inc.BioGlue Surgical Adhesive.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165020
mdprc 149 07 18 000Cayenne Medical Inc.Quattro Spade Drillhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165400
mdprc 140 07 18 000Bio-Rad Laboratories IncBioRad PR 4100 Microplate Readerhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165373
mdprc 139 07 18 000Cayenne Medical Inc.AperFix Femoral Implant Coring Removal Drillhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165389
mdprc 138 07 18 000Forte Automation Systems IncPATIENT POSITIONING SYSTEMhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165646
mdprc 137 07 18 000Life Technologies Limited.Gibco Dulbecco's Modified Eagle Medium (DMEM)https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165365
mdprc 136 07 18 000OMNIlife scienceOMNI Hip System, ApeXLNK Acetabular Insertshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165379
mdprc 135 07 18 000Tactical Medical SolutionsBLAST Bandagehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164712
mdprc 132 07 18 000Clarity Diagnostics LlcClarity Urocheck 10SG Urinalysis Stripshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165700
mdprc 131 07 18 000Ethicon Inc.PDS" Plus Antibacterial Suture, PDS" II (Polydioxanoe) Suture Dyed & Undyedhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165371
mdprc 130 07 18 000The Brewer Company, LLCAccess HiLow Exam Tables, Model 6501XXhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164734
mdprc 127 07 18 000Siemens Medical SolutionsArtis zee and AXIOM Artis systems with Laird Cooling Unit for SSFDhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165671
mdprc 120 07 18 000Carl Zeiss Meditec IncZeiss Celldiscoverer 7https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165394
mdprc 119 07 18 000Medtronic SAVisualase Cooled Laser Applicator Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165572
mdprc 118 07 18 000Philips HealthcareIngenuity Digital PET/CThttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165369
mdprc 105 07 18 000Ethicon Inc.D-Special PROLENE Polypropylene and D-Special PRONOVA Hexafluoropropylene-VDF Sutureshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165105
mdprc 104 07 18 000Fx SolutionsFx SOLUTIONS CENTERED HEADhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165089
mdprc 116 02 18 001PENTAX Europe GmbHPentax Video Duodenoscopehttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00887-1
mdprc 094 07 18 000Integra LifeSciencesThe UNICP bone fixation systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165161
mdprc 093 07 18 000Intel-GE Care Innovations LLCHealth Harmony Mobilehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165321
mdprc 090 07 18 000Canadian Hospital SpecialtiesMEDRX, Ref 541650R 5Fr X 16" (40cm) Polyurethane Feeding Tube For Pediatric Usehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165293
mdprc 089 07 18 000Edwards LifesciencesEdwards SAPIEN 3 Transcatheter Heart Valve (THV)https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165357
mdprc 088 07 18 000Medtronic SAVectris SureScan and Vectris Trial Screening Lead Kitshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164967
mdprc 087 07 18 000Opgen IncAdvanDx QuickFISH Slideshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165084
mdprc 086 07 18 000QIAGEN IncAmniSure ROM Testhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165377
mdprc 085 07 18 000Valeris Medical, LLCApollo XT Suture Anchorshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164354
mdprc 079 07 18 000Anika Therapeutics Inc.Hyalomatrixhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165068
mdprc 078 07 18 000Dako Denmark A/SPDL1 IHC 22C3 pharmDxhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162750
mdprc 074 07 18 000Cayenne Medical Inc.AperFix Femoral Implanthttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165033
mdprc 073 07 18 000Fort Defiance Industries, LLCP2131 AUTOMATED FIELD STEAM STERILIZERhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165069
mdprc 072 07 18 000Immuno-Mycologics, Inc. (IMMY)Cryptococcal Antigen Lateral Flow Assays.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165046
mdprc 071 07 18 000Ohio Medical CorporationPushToSet Intermittent Suction Unitshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165072
mdprc 069 07 18 000STERIS CorporationReliance 1227 Cart and Utensil Washer/Disinfectorhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164966
mdprc 059 07 18 000Arrow International IncVPS Rhythm ECG , VPS Rhythm ECG , Peripherally Inserted Midline Catheter Kithttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165078
mdprc 058 07 18 000Medline Industries, Inc.BARD MYPICC Kit, REF CK000095Bhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164837
mdprc 057 07 18 000Zimmer Biomet, Inc.Zimmer M/L Taper Hip Prosthesishttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164815
mdprc 043 07 18 000Trilliant Surgical LtdCannulated Driver Handleshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164836
mdprc 037 07 18 000B Braun Medical Inc26Lead Transfer Set for use with APEX Compounding Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164915
mdprc 031 07 18 000Beaver Visitec International LtdSafety Sideport Knifehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165153
mdprc 010 07 18 001Philips HealthcarePhilips Ingenuity Core128/Elite China 728324https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164781
mdprc 011 07 18 000Ion Beam Applications S.A.Proton Therapy System Proteus 235 (brand names: Proteus Plus and Proteus ONE)https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164898
mdprc 009 07 18 000Safe N Simple, LLCSafe N Simple NoSting Skin Barrier Filmhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164916
mdprc 008 07 18 000St. Jude Medical IncMerlin PCS Programmer Softwarehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164947
mdprc 005 07 18 000CenorinHLD Systems 600 Series Washer/Pasteurizerhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165073
mdprc 004 07 18 000KONICA MINOLTA, INCPanasonic Toughbook CF-C2 and CF-SX Laptopshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164903
mdprc 003 07 18 000OlympusModel PJF-160 Duodenoscopes https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164186
mdprc 121 06 18 000Exsurco MedicalAmalgatome SDhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165083
mdprc 120 06 18 000Intersurgical LimitedIntersurgical Breathing Circuit 22mm, nonconductive, single patient usehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164961
mdprc 119 06 18 000Ion Beam Applications S.A.ProteusPLUS and ProteusONEhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165077
mdprc 116 06 18 000B. BRAUN MEDICAL INCSpace Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filterhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164671
mdprc 115 06 18 000HORIBA ABX SAS.ABX Pentra Micro ALBUMIN 2 CPhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164230
mdprc 114 06 18 000Teleflex Medical Pilling(R) UNIVERSAL SHEARShttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165023
mdprc 113 06 18 000Zimmer Biomet, Inc.Various Trauma Guidewireshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164833
mdprc 105 06 18 000Cyberonics IncModel 3000 VNS Therapy Programmershttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164316
mdprc 104 06 18 000Paragon 28, IncDrill guide for the JAWS Nitinol Staple Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164789
mdprc 093 06 18 000Safe N Simple, LLCSimpurity DermaPro Waterproof Silicone Tape, Safe'n'Simple, WOUNDCAREhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164922
mdprc 092 06 18 000Synthes GmbH.Graphic Case 6.5mm & 7.3mm Cannulated Screw Setshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163239
mdprc 091 06 18 000Zimmer Biomet, Inc.Biomet Modular Primary Tibial Tray Implants (size 75 mm)https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164798
mdprc 083 06 18 000AngioDynamics IncBioFlo PICC (NV)https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164762
mdprc 082 06 18 000C2 Therapeutics Inc.Catheter, C2 CryoBalloon" Ablation Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164786
mdprc 062 06 18 000Philips HealthcareBrilliance 16 P, Brilliance 16 and Brilliance 64 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164549
mdprc 061 06 18 000bioMerieux IncThe VITEK 2, The PREVI, VIDAS TOXO IgG, Color Gram 2 and Oxidase Reagenthttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164591
mdprc 060 06 18 000Baxter HealthcareSIGMA Spectrum Infusion Pump with Master Drug Library (Version 6 and Version 8)https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164215
mdprc 059 06 18 000Carl Zeiss Meditec IncCarl Zeiss Microscopy for Laser Scanning Microscopes (Cell Observer SD, Laser TIRF and DirectFRAP)https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164575
mdprc 058 06 18 000Fresenius Medical Care.NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Litershttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164557
mdprc 057 06 18 000IBA Dosimetry GmbH12C, Proteus ONE and Proteus Plushttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164905
mdprc 056 06 18 000IBA Dosimetry GmbH12C (AdaPTinsight)https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164900
mdprc 055 06 18 000Keystone Industries t/a Harry J. Bosworth CompanyPrima Plus 4.1 x 11.5mm Implanthttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164567
mdprc 054 06 18 000Maquet Cardiopulmonary AGAortic Arterial Cannula 20, 22 and 24 Frhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164362
mdprc 053 06 18 000Smiths Medical International LimitedBivona Tracheostomy Tube Tracheostomy Tubeshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164546
mdprc 052 06 18 000Thermo Fisher Scientific Inc.remel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH W/OXACILLINhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164353
mdprc 051 06 18 000Zimmer Biomet, Inc.ROSA Robotized Stereotactic Assistant, Version 2.5https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164315
mdprc 026 06 18 000VGI Medical, LLCVerteLP Instrument Kithttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164210
mdprc 025 06 18 000Tosoh Bioscience IncSTAIA PACKhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163500
mdprc 024 06 18 000NordicNeuroLab ASfMRI Hardware System AudioSystem, Version 1.0https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160719
mdprc 023 06 18 000C R Bard IncBardex Lubricath 3Way 75cc Continuous Irrigation Foley Catheterhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164685
mdprc 020 06 18 000Randox Laboratories Ltd.RX Imolahttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164051
mdprc 019 06 18 000NordicNeuroLab ASnordicICE v 2.3.14https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159628
mdprc 009 06 18 000Stryker CommunicationsDRILOK THREADED CANNULAhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164124
mdprc 008 06 18 000SANTA JOY ORNAMENT & GIFTWARE COEZ Illuminations Northern Lights EZ Illuminations Galaxyhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160993
mdprc 007 06 18 000NordicNeuroLab ASnordicBrainEXhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164721
mdprc 006 06 18 000Medical Action Industries IncMedical Action Industries Inc. Blue OR Towel Non XRay Detectable (6 Towels per Pack)https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164683
mdprc 005 06 18 000Ii-Vi IncorporatedNonCertified laser diode componenthttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164228
mdprc 004 06 18 000Hobbs Medical, IncHobbs Bronchial Cytology Brusheshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163898
mdprc 003 06 18 000Arrow International IncMultible Catheter, percutaneous, Needlshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163837
mdprc 002 06 18 000WRP ASIA PACIFIC SDN BHDAmerisourceBergen Sterile Latex Surgical Gloves, Powder Freehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164146
mdprc 001 06 18 000Philips HealthcareHeartStart MRx Monitor/Defibrillatorhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164128
mdprc 146 05 18 000Respire MedicalRespire Pink Hard/Softhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164720
mdprc 145 05 18 000Genesee BIOMEDICAL, INC.Sternal Valve Retractors with Atrial and Aortic Attachmentshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164233
mdprc 144 05 18 000Dynarex CorporationDynarex CGA870 All Brass Oxygen RegulatorAll Brass 025 LPM, Barb & 2DISS Outlethttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164303
mdprc 143 05 18 000Cook Medical Europe LimitedMINC Benchtop Incubatorshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163146
mdprc 139 05 18 000Symmetry SurgicalSYMMETRY Olsen Single-Use Electrocautery Forceps, Pencils, and Cordshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164447
mdprc 138 05 18 000Siemens Healthcare Diagnostics ProductSyva Emit 2000 Theophylline Assayhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162253
mdprc 137 05 18 000Medline Industries IncNeedle Countershttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164217
mdprc 136 05 18 000Siemens Medical SolutionsSiemens Biograph Horizonhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164356
mdprc 135 05 18 000Baxter HealthcarePrismaflex Control Units https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164046
mdprc 134 05 18 000Baxter HealthcareEXACTAMIX Inletshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164079
mdprc 118 05 18 000LivaNova USAINSPIRE 6 and INSPIRE 8 hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoirhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163774
mdprc 117 05 18 000Smith & Nephew inc5o (degree) GENESIS(R) II VALGUS BUSHINGhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163785
mdprc 116 05 18 000Spinal ElementsAMENDIA Omega Lumbar Interbody Fusion Devicehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163816
mdprc 115 05 18 000Synthes GmbH.Synthes Torque Limiting Handlehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164278
mdprc 114 05 18 000Teleflex MedicalTeleflex MEDICAL LMA(TM) MADgichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162883
mdprc 101 05 18 000Beckman CoulteriChem(R) VELOCITY Urine Chemistry Stripshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163764
mdprc 100 05 18 000Southmedic IncSouthmedic Sterile Disposable Scalpel Rx onlyhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164365
mdprc 099 05 18 000VOLCANO CORPORATIONPhilips Volcano Core M2Imaging Systemshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163160
mdprc 094 05 18 000Coltene Whaledent Inc.Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 packhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164149
mdprc 093 05 18 000ConvaTecConvatec Esteem(TM) Synergy Stomahesive(R)https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164023
mdprc 088 05 18 000CooperSurgical IncFischer Cone Biopsy Excisorhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163620
mdprc 087 05 18 000Epic Extremity, LLCEpic Extremity Plate Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163592
mdprc 086 05 18 000Micro-Tech (Nanjing) Co., LtdTrident Endoscopic Ultrasonic Aspiration Needle (FNA)https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163919
mdprc 085 05 18 000Nipro Medical CorporationNipro Blood Tubing set with Priming Set and Transducer Protectors. Each device is packaged in a filmhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163665
mdprc 082 05 18 000Draeger Medical Systems IncMonitor, Physiological, Patient (with Arrhythmia Detection or Alarms)https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163782
mdprc 081 05 18 000Kelyniam Global, Inc.Kelyniam CSIhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163449
mdprc 080 05 18 000Rockwell Medical, IncDriSatehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163799
mdprc 079 05 18 000Tosoh Bioscience IncTosoh ST AIAPACK HbA1c Calibratorhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163114
mdprc 078 05 18 000Bard Pcripheral Vascular (BPV)POWERPORT(R) ClearVUEhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163713
mdprc 077 05 18 000ICU Medical, IncHemodynamic Monitoring Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163535
mdprc 076 05 18 000Medtronic SAMedtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREWhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163451
mdprc 075 05 18 000Ninepoint Medical Inc.NvisionVLEhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163810
mdprc 074 05 18 000Parker Laboratories, IncSterile Aquasonic 100 Ultrasound Transmission Gelhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163914
mdprc 073 05 18 000Siemens Medical SolutionsSyngo.Via VB20A model 1049610https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163815
mdprc 064 05 18 000Beaver Visitec International LtdWetField Hemostatic Eraser Bipolar 25Ghttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163934
mdprc 063 05 18 000C R Bard IncSEEKER(R) Crossing Support Catheterhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163824
mdprc 062 05 18 000Inpeco S.A.FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2)https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162888
mdprc 061 05 18 000Ondamed IncOndamed Biofeedback Devicehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163767
mdprc 060 05 18 000TP Orthodontics Inc.Jasper Vektorhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163879
mdprc 059 05 18 000Vyaire MedicalResuscitation Devices https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163362
mdprc 050 05 18 000Zimmer Biomet, Inc.LactoSorb RapidFlap Spindown Instrumentshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164133
mdprc 049 05 18 000Microline Surgical Inc. ReNew brand Disposable Scissor and Dissector Tipshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162315
mdprc 048 05 18 000DePuy International LtdLATARJET EXPERIENCE Sharp Curved OstetomeFAROUK, MAAMOUN TAMER & COMPANY
mdprc 047 05 18 000Datascope CorpCustom Tubing Pack with Bioline Coating.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163787
mdprc 034 05 18 000Vygon UK LtdPICC Insertion Trayhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163553
mdprc 033 05 18 000Straumann Manufacturing, Inc.Straumann Emdogainhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163233
mdprc 032 05 18 000Siemens Medical SolutionsSyngo Plazahttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163390
mdprc 029 05 18 000Conseal International, Inc.Nanosil Spray Gelhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164041
mdprc 028 05 18 000IntroMedic Co., Ltd.MiroCam Capsule Endoscope Systehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163624
mdprc 027 05 18 000PerkinElmer Life and Analytical SciencesNeoBase Succinylacetone Assay Solutionhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161848
mdprc 021 05 18 000Beijing Syntech Laser Co., LtdLaser Handpiecehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163046
mdprc 020 05 18 000Stryker Communications Corp6381 M1 and 6376 M1 Cot Fastenerhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163576
mdprc 019 05 18 000DeRoyal Industries Inc.DeRoyal(R) SURGI MATE(R) Electrosurgical Pencil, Button Switchhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163991
mdprc 018 05 18 000CooperSurgical Inc.Apple-Hunt Secondary Cannula/Pyramidal Tip Trocarhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163601
mdprc 011 05 18 000Cardinal-HealthMediVac(TM) Flex Advantage(TM) Suction Canister Linerhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163108
mdprc 158 04 18 000Accelerate Diagnostics IncAccelerate PhenoTest BC kithttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162852
mdprc 157 04 18 000Beaver Visitec International LtdWETFIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVEDhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163908
mdprc 156 04 18 000PerkinElmer Life and Analytical SciencesSpecimen Gate Screening Center Systemshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162274
mdprc 155 04 18 000Polymer Technology Systems, IncPTS Panels CHOLGLU Test Stripshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163394
mdprc 150 04 18 000Ethicon IncEvicel Accessory Devicehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162948
mdprc 149 04 18 000HEIDELBERG ENGINEERING GmbHWidefield OCT softwarehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162348
mdprc 148 04 18 000Menarini Silicon BiosystemsCELLSEARCH Circulating Tunor Cell Kit (Epithelial)https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163784
mdprc 147 04 18 000Smith & NephewWHIPKNOT Soft Tissue Cinchhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163060
mdprc 146 04 18 000Stryker EuropeHinge Coupling Hoffmann LRFhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163236
mdprc 145 04 18 000Zimmer Biomet, Inc.Biomet Hip Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162993
mdprc 138 04 18 000Cook Medical Europe LimitedAdvance 35LP LowProfile PTA Balloon Dilatation Catheterhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163783
mdprc 137 04 18 000Roche Diagnostics CorpEnzymatic assay for the determination of Acetaminophenhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162582
mdprc 136 04 18 000Zimmer Biomet, Inc.Orthopedic Salvage System Modular Arthrodesis Nail 0° Collar Assemblies with Locking Boltshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163021
mdprc 126 04 18 000NeuroLogicaGMR40https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162862
mdprc 125 04 18 000Siemens Medical SolutionsMEVATRON , ONCOR , PRIMUShttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163344
mdprc 124 04 18 000Crimson Trace CorporationCTC laser sightshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162939
mdprc 123 04 18 000Keystone Dental Inc.Genesis Surgical Cassette Taperedhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163234
mdprc 122 04 18 000Stryker InstrumentsStryker Togahttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163400
mdprc 142 03 18 001ConMed Corporation.PadPro MiniInfant Multifunction Electrodes 2602 SeriesFDA and BfArM
mdprc 108 04 18 000Ace Surgical Supply Co., IncDouble Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163464
mdprc 107 04 18 000Cook Medical Cook Vacuum Pumphttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163165
mdprc 106 04 18 000Integra LifeSciencesTITANhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162744
mdprc 105 04 18 000Life Technologies Limited.Oncomine Dx Target Test.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162895
mdprc 104 04 18 000Terumo Cardiovascular Systems CorporationTerumo Advanced Perfusion System 1 Flow Module.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162847
mdprc 103 04 18 000TMJ Solutions IncTMJ Concepts PatientFitted TMJ Reconstruction Prosthesis Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162774
mdprc 089 04 18 000AutochairMilford Smartbasehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162854
mdprc 088 04 18 000Halyard Health Co.Halyard Health Closed Suction Kits with Flex Connectorhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162853
mdprc 087 04 18 000Philips HealthcareNuclear, Magnetic Resonance Imaginghttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162712
mdprc 086 04 18 000Draeger Medical Systems IncInfinity Acute Care System (lACS) Monitoring Solutionhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162928
mdprc 085 04 18 000Preservation Solutions, IncBelzer UW & Waters IGL Cold Storage Solutionhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162159
mdprc 084 04 18 000Southern Implants, IncImplant, Ext. Hex, tapered 12o CoAxishttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162906
mdprc 083 04 18 000Zimmer Biomet, Inc38 mm Offset Segmental System Proximal Femoral Componentshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162988
mdprc 077 04 18 000Fresenius Medical CareLiberty Select Cyclerhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162848
mdprc 076 04 18 000Tornier IncPhantom Fiber Biofiber Sutureshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162146
mdprc 075 04 18 000Bard Pcripheral Vascular (BPV)Nasogastric Sump Tubes with ENFit Connectorhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162514
mdprc 074 04 18 000Certified Safety Mfg IncFirst aid/emergency kits containing Honeywell eyewashhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162951
mdprc 073 04 18 000The Magstim Company LimitedRapid2 Therapy Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162681
mdprc 072 04 18 000OrthofixORTHOFIX, Connector System, SMALL and LARGE SET SCREWhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162480
mdprc 069 04 18 000Arrow International IncMultible Introducers and Cathetershttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162552
mdprc 068 04 18 000Ethicon Inc.PDS Plus Antibacterial monofilament syntheticabsorbable sutureshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162610
mdprc 066 04 18 000ICU Medical, IncSmallbore Ext Set w/MicroClave, Clave TConnector, Clamp, Rotating Luerhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161287
mdprc 065 04 18 000Nidek Inc.AUTO REF/KERATOMETER ARK1shttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162625
mdprc 064 04 18 000Reliance Medical Products.Refractor Suspension Arm (P/N: 525004, 05 and 525006, 07)https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162749
mdprc 063 04 18 000Shenzhen MindrayM-30D Diluent used with BC-3200 and BC-3600 Auto Hematology Analyzers , Hematology Diluent M-53D used with BC-5390 Hematology Analyzerhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162631
mdprc 052 04 18 000Lifeline Systems, IncorporatedHomeSafe AutoAlert Pendant, AAHB, or AutoAlert Fall Detectorhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161078
mdprc 051 04 18 000Phadia LtdImmunoCAP Allergen c6, Amoxicilloylhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162339
mdprc 050 04 18 000Philips BurtonIntellivue X3https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160242
mdprc 049 04 18 000Smith & Nephew incDRAD SelfTapping Locking Screwhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162539
mdprc 048 04 18 000Terumo Cardiovascular Systems CorporationCardiovascular Procedure Kits, Tubing Packhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162581
mdprc 032 04 18 000Magellan Diagnostics IncLeadCare Plus and LeadCare II Blood Lead Analyzerhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161822
mdprc 031 04 18 000Siemens Medical SolutionsSyngo.via.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162599
mdprc 030 04 18 000Zimmer Biomet, Inc.A.L.P.S. MinimallyInvasive (MIS) and Mesh Calcaneus Plating Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162202
mdprc 027 04 18 000Seiler Instrument & Manufacturing Inc, CoAlpha Air 6 ENT Microscopehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162123
mdprc 026 04 18 000Fresenius Medical Care.2008 Series Hemodialysis Machinehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162434
mdprc 025 04 18 000Ion Beam Applications S.A.Proteus 235 Proton Therapy Systemshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161705
mdprc 024 04 18 000Medical Components, Inc8F Plastic Dignity Low Profile CT Porthttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162340
mdprc 023 04 18 000Medtronic SA6F Taiga Guiding Catheterhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162346
mdprc 022 04 18 000Mesa Laboratories, Inc.SporAmpule Biological Indicatorhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162162
mdprc 021 04 18 000SIE AG, Surgical Instrument EngineeringFEMTO LDV(TM)Z8 Femtosecond Surgical Laserhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162149
mdprc 008 04 18 000Allen Medical SystemsTrumpf Medical T3 Spinal Tabletop Systemshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162773
mdprc 007 04 18 000Arrow International IncARROW ENDURANCE" Extended Dwell Peripheral Catheter Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162429
mdprc 006 04 18 000Deerfield ImagingIMRIS ORT300 Removable Operating Room Tablehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162137
mdprc 005 04 18 000Encore Medical, LpAltiVate Reverse, HUMERAL SOCKET SHELL TRIAL, STANDARDhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162109
mdprc 004 04 18 000Roche Diagnostics Corpcobas c 6000 MODULAR Series System e 601https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161278
mdprc 003 04 18 000Siemens Medical SolutionsSyngo.via softwarehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162538
mdprc 002 04 18 000Zimmer Biomet, Inc.Phoenix Nail Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162454
mdprc 001 04 18 000Zimmer Biomet, Inc.PERSONA THE PERSONALIZED KNEE SYSTEMhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162203
mdprc 154 03 18 000Cook Medical Europe LimitedNorm-Ject Tuberkulin Syringeshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162423
mdprc 153 03 18 000GE HealthcareTec 7 Vaporizer, Aisys CS2 Aladin Cassettehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162478
mdprc 152 03 18 000Madison Polymeric EngineeringFirst Step Flexible Endoscope Bedside PreClean Kit, EP4.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162225
mdprc 151 03 18 000Ohmeda MedicalRotating IV Polehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162347
mdprc 150 03 18 000Quidel CorporationSofia 2https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161800
mdprc 141 03 18 000Zimmer Biomet, Inc.Comprehensive Segmental Revision Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162212
mdprc 140 03 18 000GETINGE US SALES LLCHEMASHIELD Knitted Double Velour Cardiovascular Fabrichttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162603
mdprc 139 03 18 000Circulatory Technology IncBetterBladderhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162626
mdprc 138 03 18 000Becton Dickinson & Co. (BD)BD Vacutainer EDTA Tubeshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161776
mdprc 137 03 18 000Beckman CoulterAutoMate 2500 Familyhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161071
mdprc 136 03 18 000Arrow International IncARROW, ARROWGARD AND ARROWGARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETERhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162075
mdprc 123 03 18 000Arrow International IncARROWgard Blue PLUShttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162585
mdprc 122 03 18 000Bovie Medical CorporationJ-Plasma Handpieceshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162211
mdprc 121 03 18 000Ethicon Inc.Dermabond " Prineo " Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162112
mdprc 120 03 18 000Medica Corporation.Chemistry Wash1 REF 10680https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161792
mdprc 119 03 18 000Vascular Insights, LLCClariVein IC infusion catheterhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161969
mdprc 115 03 18 000Merit Medical Systems, IncCustom Dialysis Kithttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162332
mdprc 111 03 18 000CooperSurgical Inc2 MHZ Waterproof OB Probehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161662
mdprc 110 03 18 000HYPHEN BioMedZYMUTEST HIA IgGAMhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161801
mdprc 109 03 18 000IRIDEX CorporationLaser Indirect Ophthalmoscope (LIO) .https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162191
mdprc 108 03 18 000Medical Components, IncREPAIR KIThttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162326
mdprc 107 03 18 000OMNIlife scienceApex Knee Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161796
mdprc 106 03 18 000Smith & Nephew incLEGION HK FEMORAL WEDGEhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161747
mdprc 105 03 18 000Smiths Medical ASD IncPower PORTACATHhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162308
mdprc 104 03 18 000Stanbio Laboratory, LPRF Latex Reagenthttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161742
mdprc 103 03 18 000Zimmer Biomet, Inc.Cannulated Screw Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162192
mdprc 096 03 18 000Zimmer Biomet, Inc.Comprehensive Shoulder Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162190
mdprc 095 03 18 000Zimmer Biomet, Inc.Vanguard Complete Knee Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161749
mdprc 094 03 18 000Zimmer Biomet, Inc.SnapShot" Fixation Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161802
mdprc 093 03 18 000Zimmer Biomet, Inc.Ringloc CoCr Modular Femoral Headshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161757
mdprc 092 03 18 000Zimmer Biomet, Inc.NEXGEN LPSFLEX MOBILE AND LPSMOBILE BEARING KNEE SYSTEMhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162418
mdprc 091 03 18 000Zimmer Biomet, Inc.JUGGERKNOThttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161740
mdprc 090 03 18 000Fresenius Medical CareNaturaLyte Liquid Acidhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161727
mdprc 089 03 18 000Alden OpticalAlden Soft contacthttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162157
mdprc 072 03 18 000Roche Diagnostics Corpcobas 6000, cobas 8000https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161418
mdprc 071 03 18 000Medimop Medical Projects Ltd.Via2BagDirect Connecthttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161741
mdprc 070 03 18 000Laerdal Medical AsAPPARATUS, SUCTION, WARD USE, PORTABLE, ACPOWEREDhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161566
mdprc 063 03 18 000Abbott Point of CareiSTAT DEhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161446
mdprc 062 03 18 000Becton Dickinson & Co. (BD)Difco Agar Noble, 500g bottlehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161669
mdprc 061 03 18 000Cook MedicalHeparin-Coated Guidewires and Catheter Setshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161581
mdprc 060 03 18 000Ion Beam Applications S.A.ProteusONEhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161706
mdprc 059 03 18 000Ion Beam Applications S.A.ProteusONE and ProteusPLUS Proteus 235 Proton Therapy Systemshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161709
mdprc 058 03 18 000Ion Beam Applications S.A.Proteus 235https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161689
mdprc 057 03 18 000Zimmer incTrabecular Metal Primary Hip Prosthesishttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162208
mdprc 056 03 18 000Z-Medica LLCQuikClot Trauma Padhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162235
mdprc 047 03 18 000Covidien LLCstaple, implantable, Endo GIAhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161502
mdprc 046 03 18 000Ortho-Clinical DiagnosticsVITROS DAT Performance Verifierhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161474
mdprc 045 03 18 000Stryker Sustainability SolutionsStryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Cathetershttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161322
mdprc 044 03 18 000Wiener LaboratoriesWiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161541
mdprc 032 03 18 000DePuy International LtdConcorde Lifthttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161277
mdprc 031 03 18 000Stryker CommunicationsStrykeFlow 2 suction/irrigator, STRYKER WEDGE, ACL DISPOSABLE , STRYKER CASSETTE PUMPhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160091
mdprc 030 03 18 000ToshibaFluoroscopic XRay Systemshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161847
mdprc 028 03 18 000Accord Media, LLCUltra Renew, Truth Renew, Ultra Renew Plus, Truth Renew Plushttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161783
mdprc 027 03 18 000Alto Development CorpMYO/Punch; A&E Surgical Punchhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161805
mdprc 026 03 18 000Baxter HealthcareSterile EXACTAMED Oral Liquid Dispenserhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161319
mdprc 025 03 18 000Hitachi America, Ltd.UST5550R Ultrasound Transducerhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161462
mdprc 024 03 18 000Howmedica Osteonics Corp.ORTHOPEDIC MANUAL SURGICAL INSTRUMENThttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161444
mdprc 023 03 18 000NxStage Medical, Inc.Dialysate Sacks https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161554
mdprc 022 03 18 000Otto Bock Healthcare Products GmbHOTTO BOCK Kenevo knee jointshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161206
mdprc 017 03 18 000Avid Medical, Inc.AVID TruCustomhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161497
mdprc 016 03 18 000B Braun Medical IncSterile IV Start Kithttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149990
mdprc 010 03 18 000Cosmedent, Inc.Dentin/Enamel Etchhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159642
mdprc 009 03 18 000Keystone Dental Inc.RESTORE, STAGE1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTShttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161389
mdprc 008 03 18 000Keystone Dental Inc.Max Implant Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161267
mdprc 007 03 18 000Medistim ASAVeriQ Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160991
mdprc 006 03 18 000Steris CorporationSterilization Wraphttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161343
mdprc 005 03 18 000Terumo BCT IncDestination Guiding Sheathhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161503
mdprc 130 02 18 000Arrow International IncARROW PICChttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161626
mdprc 129 02 18 000Atrium Medical CorporationProLite Meshhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161830
mdprc 128 02 18 000DePuy International LimitedFMS Gravity Tube Sethttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161398
mdprc 127 02 18 000Siemens Medical SolutionsArtis Q and Q.Zen, Artis Zee and Zeego, Axiom Artishttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161336
mdprc 126 02 18 000Med Tec IncProtura Software which utilizes Elektas iCOM interfacehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161544
mdprc 125 02 18 000Zimmer, INCNexGen LPShttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160970
mdprc 117 02 18 000Medtronic SAImplantable Cardioverter Defibrillators (ICDs)https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161074
mdprc 101 02 18 000DeRoyal Industries Inc.GEOMED CABG PACK PGYBK A & Bhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161247
mdprc 100 02 18 000Zimmer, INCROSA 1.0.2, ROSA 3.0 (Spine application)https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160940
mdprc 096 02 18 000AesculapELAN 4 Air Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161326
mdprc 095 02 18 000AesculapELAN 4https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161269
mdprc 094 02 18 000AesculapSterilization wrap, JS Series SterilContainer"S2 Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161320
mdprc 093 02 18 000Cook Inc,Central Venous Catheter.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161240
mdprc 092 02 18 000Fukuda DenshiFukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitorhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159575
mdprc 091 02 18 000Zimmer BiometAGC Porous Patellar SM and Medhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161330
mdprc 090 02 18 000Zimmer BiometAcetabular Hip Replacement Componentshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161382
mdprc 084 02 18 000Gibson Laboratories LLCGibson Bioscience Blastomyces dermatitidis Antiserumhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160239
mdprc 083 02 18 000Keystone Dental Inc.PrimaConnex Implant Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161223
mdprc 082 02 18 000OrthoPediatrics Corpthoracolumbosacral pedicle screw systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161268
mdprc 081 02 18 000PENTAX Europe GmbHVideo Cystoscope models ECY1570 and ECY1570Khttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161420
mdprc 080 02 18 000Sanofi GenzymeSynviscOnehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160495
mdprc 060 02 18 000Beckman CoulterAU Lyophilized Chemistry Level 1 Calibratorshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160143
mdprc 059 02 18 000ConforMISiTotal Posterior Stabilized (PS) Knee Replacement Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160828
mdprc 058 02 18 000ExactechExactech GPS Total Shoulder Application 3.2mm Vix Bithttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158599
mdprc 057 02 18 000Synthes IncTitanium Trochanteric Fixation Nail (TFN)https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160966
mdprc 056 02 18 000CepheidXpert CT/NG.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160839
mdprc 055 02 18 000HOLOGIC NVHologic Panther(R) Fusionhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161072
mdprc 044 02 18 000Avid Medical, Inc.AVID Medical QA Packhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161426
mdprc 043 02 18 000B Braun Medical IncSpinal & Epidural Anesthesia Trayhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160795
mdprc 042 02 18 000Cyberonics IncVNS(R) Therapy Programmerhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160846
mdprc 041 02 18 000LITTLE RAPIDS CORPORATIONSnugFit(R) Expandable Mattress Coverhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160825
mdprc 040 02 18 000Medtronic SAMedtronic ANGLED DRILLhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160709
mdprc 039 02 18 000Mindray DS USA, Inc., dba Datascope Patient MonitoringTD60 Transmitter Battery Chargerhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161211
mdprc 038 02 18 000Philips HealthcareHeartStart MRx Monitor/Defibrillatorhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159291
mdprc 037 02 18 000Smiths MedicalCustom Made Tracheostomy Devicehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161230
mdprc 036 02 18 0003M Health Care LtdACE(TM) BRAND, ULTRA LITE ANKLE bracehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159601
mdprc 035 02 18 000Robert Busse & Co. IncLumbar Puncture Trayhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160967
mdprc 034 02 18 000Zimmer BiometZimmer Natural Nail System Tear Drop Guide Wirehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158903
mdprc 030 02 18 000Implant Direct Sybron Manufacturing,LLCImplant Direct, INTERACTIVE HEALING COLLARhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160855
mdprc 029 02 18 000Medical Components, IncPlastic Dignity Low Profile CT Porthttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158909
mdprc 025 02 18 000ConvaTecSURFIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Collarhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159675
mdprc 024 02 18 000Siemens Medical SolutionsSyngo.plaza systems.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160104
mdprc 023 02 18 000Spacelabs Healthcare IncSpacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161031
mdprc 022 02 18 000Panoramic Rental Corp.Panoramic Xray Model PC1000, Laser1000https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158982
mdprc 010 02 18 000Siemens Medical SolutionsSyngo.plaza Picture Archiving and Communication Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161248
mdprc 009 02 18 000Tosoh CorporationTosoh Automated Enzyme Immunoassay Analyzer AIA900, Tosoh Sorter 9tray and Tosoh Sorter 19trayhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160396
mdprc 004 02 18 000AlereTriage Drugs of Abuse Plus TCA 25 Test Kithttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159878
mdprc 003 02 18 000C R Bard IncUROS AUTOMATED URINE OUPTUT AND TEMPERATURE MONITORhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158971
mdprc 002 02 18 000ExactechEquinoxe Cage, Glenoid, Alpha, Small and Mediumhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160830
mdprc 097 01 18 000Carl Zeiss Meditec IncMetrotom 800https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160805
mdprc 096 01 18 000SOMATEX Medical Technologies GmbHTumark Qhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159289
mdprc 094 01 18 000Inovo, IncPure Stationary Oxygen Concentrators https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160803
mdprc 093 01 18 000Siemens Medical SolutionsSyngo Imaginghttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160841
mdprc 092 01 18 000Smith & Nephew incEVOS FLEX PLATEhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160095
mdprc 091 01 18 000Smith & Nephew incRadial Osteotome Bladehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159544
mdprc 090 01 18 000Vyaire MedicalAirLife Humidification Chambers and Heated Breathing Circuits https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160041
mdprc 078 01 18 000Valeant Pharmaceuticals International, IncSPAG2 unit nebulizershttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155627
mdprc 074 01 18 000Measurement Specialties Inc.Measurement Specialties Reusable Temperature Probe Autoclavablehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158538
mdprc 073 01 18 000Philips HealthcareBrilliance iCT, Brilliance 64, Ingenuity Core, and Ingenuity Core128 Computed Tomography Systemshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160870
mdprc 072 01 18 000Smith & Nephew incMiniMod Small Bone Plating Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160614
mdprc 071 01 18 000The Anspach Effort, IncOSCILLATING SAW ATTACHMENThttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160829
mdprc 062 01 18 000ZOLL Medical CorpLifeVest Wearable Defibrillatorhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160876
mdprc 060 01 18 000Merge Healthcare Corp.Mighty 8 Power strip, TrippLite Power striphttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154394
mdprc 058 01 18 000DeRoyal Industries Inc.DeRoyal Sterile Custom kitshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160713
mdprc 052 01 18 000Physio Control IncLIFEPAK 20e Defibrillator/Monitors https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159792
mdprc 051 01 18 000SPINEARTTRYPTIK(R) 2 CPLATE SELFTAPPING POLYAXIAL SCREWhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160051
mdprc 046 01 18 000Amendia, IncMac Pin NonCannulated Screwhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158459
mdprc 045 01 18 000Encore Medical, LpEMPOWR Porous Knee System TIBIAL PUNCH, LARGE, MEDIUM and SMALLhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160234
mdprc 044 01 18 000OrthoScan, Inc.OrthoScan Mobile DI Mini Carm, OrthoScan Mobile DI Mini Carm, HD (10000001), HD (10000004)https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160429
mdprc 037 01 18 000Amendia, IncCeres SelfDrilling Variable Screw 4.0 x 12mmhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158455
mdprc 036 01 18 000King Systems Corp. dba Ambu, Inc.UNIVERSAL FLEX2 BREATHING CIRCUIThttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160526
mdprc 035 01 18 000ProSun International, LLCSundream 12 V tanning bedhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159784
mdprc 034 01 18 000Repro-Med Systems, IncFreedom 60 Precision Flow Rate Tubing Setshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153551
mdprc 033 01 18 000Zimmer Biomet, Inc.RingLoc Acetabular Shellshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160291
mdprc 019 01 18 000Smiths Medical ASD IncCADD Legacyhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160096
mdprc 002 01 18 000St. Jude Medical IncAgilishttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156097
mdprc 001 01 18 000Zimmer incOSS CEMENTED IM STEM , CER BIOLOXD OPTION HD , CER OPTION TYPEhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158814
mdprc 119 12 17 000Accuray IncTomoHDA Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160116
mdprc 103 12 17 000L3 Security & DetectionExaminer 3DX 6000 StandAlone & InLine Systemshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160074
mdprc 102 12 17 000Ortho-Clinical DiagnosticsVITROS Chemistry Products PHYT Slideshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156825
mdprc 101 12 17 000Randox Laboratories Ltd.HbA1chttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156814
mdprc 100 12 17 000Stryker NeurovascularStroke Fast Pack.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159875
mdprc 099 12 17 000Stryker Sustainability SolutionsVenaFlow Calf Garment (Aircast)https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160214
mdprc 081 12 17 000C R Bard IncArcticGel Padshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160082
mdprc 080 12 17 000C R Bard IncI125 CE Marked QuickLink Cartridgeshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156058
mdprc 079 12 17 000NXTHERARezum Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157922
mdprc 064 12 17 000AngioDynamics IncBioStable 5F DL55CM MST70 KIT NonValved w/ Nit GWhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160033
mdprc 063 12 17 000ConMed CorporationPopLok Knotless Suture Anchor with Disposable Driverhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154857
mdprc 062 12 17 000Ortho-Clinical DiagnosticsenGen Laboratory Automation Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155157
mdprc 056 12 17 000Amendia, IncOmni Spine Anterior Cervical Plate Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159848
mdprc 055 12 17 000DUKALDukal Burn Sheetshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159183
mdprc 054 12 17 000FUJIFILM Medical SystemsFDR Visionary Suite with CH200 stationary xray systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160059
mdprc 041 12 17 000Biosense Webster Inc.SMARTABLATE Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156581
mdprc 040 12 17 000United Nuclear Scientific Supplies, LLCHigh Power Handheld Laserhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159398
mdprc 026 12 17 000DeRoyal Industries Inc.DeRoyal Sterile Custom kitshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159686
mdprc 025 12 17 000ExactechVintage Total Ankle Tibia Inserthttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156247
mdprc 024 12 17 000Won Industry Co.Morning Lifehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158850
mdprc 012 12 17 000VOLCANO CORPORATIONVolcano s5i, CORE and CORE Mobile systemshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159781
mdprc 003 12 17 000Implant Direct Sybron Manufacturing,LLCLegacy 3 Implanthttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159290
mdprc 002 12 17 000Medtronic IncEverflex SelfExpanding Peripheral Stent with Entrust Delivery Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159783
mdprc 125 11 17 000Brainlab AGBRAINLAB EXACTRAC VEROhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159653
mdprc 124 11 17 000Zimmer BiometComputer Assisted Surgical Device.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157472
mdprc 123 11 17 000Zimmer BiometComputerAssisted Surgical Devicehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159343
mdprc 122 11 17 000Zimmer BiometROSA Spine 1.0.2https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159599
mdprc 094 11 17 000Medline Industries IncTransfer/Gait Belthttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159345
mdprc 093 11 17 000Becton Dickinson & Co. (BD)BD Phoenix PMIC107https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155855
mdprc 092 11 17 000Zimmer BiometComputerAssisted Surgical Device.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157814
mdprc 091 11 17 000Zimmer BiometComputerAssisted Surgical Device..https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159350
mdprc 090 11 17 000Siemens Medical SolutionsSyngo.plazahttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156080
mdprc 089 11 17 000Resource Optimization & Innovation LlcRegard Custom Surgical Packhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159384
mdprc 088 11 17 000Medline Industries Inc….Green Polyisoprene Surgical Gloves with Aloe Verahttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159624
mdprc 081 11 17 000AbbottCELL-DYN RubyNCMDR
mdprc 080 11 17 000Zimmer BiometComputerAssisted Surgical Devicehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157798
mdprc 079 11 17 000Zimmer BiometComputerAssisted Surgical Device, ROSA BRAIN 3.0.0https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157797
mdprc 078 11 17 000Terumo BCT IncHARVEST(R) TERUMOBCT, BMAC3007 Bone Marrow Procedure Packhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159143
mdprc 077 11 17 000Smith & Nephew incLEGION LWEDGE.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158754
mdprc 076 11 17 000Medline Industries Inc….MEDLINE PEDI ELBOW and COUBLE SWIVEL CLOSED SUCTION CATHETERhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159165
mdprc 075 11 17 000ICU Medical, IncICU Medical Intravenous Sets with Stopcockshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158863
mdprc 074 11 17 000Smith & Nephew incLEGION LWEDGEhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158754
mdprc 073 11 17 000Smith & Nephew incTRIGEN INTERTAN 10Shttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159397
mdprc 072 11 17 000Siemens Medical SolutionsSymbia Intevo 6 and 16https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158854
mdprc 071 11 17 000Arthrex InciBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERALhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159082
mdprc 049 11 17 000Smiths Medical ASD Inc..CADD Medication Cassette Reservoirhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159024
mdprc 048 11 17 000WalkMed Infusion, LLCReservoir Bag for Infusion Pumphttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159086
mdprc 037 11 17 000Zimmer inc Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Kneehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159084
mdprc 036 11 17 000Windstone Medical Packaging, IncT&A Packhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159349
mdprc 035 11 17 000Terumo BCT IncHarvest Graft Delivery GDP-10 Procedure Packs ,https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159146
mdprc 034 11 17 000Sorin GroupFlexFlowTM venous cannula Catalog 200200https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159209
mdprc 033 11 17 000Northgate9195371DS Lithrotripsy Probe LotLDS12516https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155847
mdprc 032 11 17 000North Star Imaging IncXray Cabinet Modelshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159021
mdprc 031 11 17 000Invivo CorporationFlex Cardio Patient Monitoring Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159623
mdprc 030 11 17 000Epimed International IncTuohy Epidural Needleshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158023
mdprc 029 11 17 000Encore Medical, LpCobalt HV Bone Cement..https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158794
mdprc 028 11 17 000Bioseal CorporationCustom surgical kitshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159381
mdprc 027 11 17 000Aaren Scientific Inc,Z28 Cartridgeshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158541
mdprc 012 11 17 000Teleflex MedicalTeleflex(R) Percuvance(TM) Percutaneous Surgical System, Gripper Grasperhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159243
mdprc 108 10 17 000Alcon Laboratories Inc.Alcon Surgical Procedure Packshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158368
mdprc 107 10 17 000Bios S.r.l.THERMI250 Radiofrequency Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157831
mdprc 106 10 17 000EDAP TMS FRANCE SASAblatherm Integrated Imaging devicehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158643
mdprc 100 10 17 000Beckman CoulterPower Processor 1K Stockyardhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158433
mdprc 087 10 17 000Kamiya Biomedical Company, LLC KAssay(R) MultiAnalyte Calibratorhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158212
mdprc 086 10 17 000Hologic IncPanther(R) Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158900
mdprc 085 10 17 000Genesys Orthopedic SystemsGenesys spine, Binary Screwdriverhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158848
mdprc 084 10 17 000Encore Medical, LpEMPOWR PS KNEE(TM) ehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158867
mdprc 065 10 17 000Toshiba Medical Systems CorporationKalare (DREXKL80)https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158813
mdprc 052 10 17 000Handicare LtdCarina Mobile Lifts https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158744
mdprc 034 04 17 001bioMerieux IncNucliSENS Lysis Bufferhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153791
mdprc 044 10 17 000Handicare LtdPRISM MEDICAL A625https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158653
mdprc 030 10 17 000Philips HealthcareIntelliVue Information Centers, Monitorshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156055
mdprc 018 10 17 000Implant Direct LLCSwish DuoGrip Healing Collarhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157875
mdprc 010 10 17 000BOMImed IncBOMImed Disposable Fiber Optic Medium Laryngoscope Handlehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158329
mdprc 009 10 17 000Medtronic SAHeli-FX Guide Deviceshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158729
mdprc 008 10 17 000Novadaq Technologies Inc.SPY-PHI Drapeshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158170
mdprc 007 10 17 000Radiometer America IncAutoCheck5https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158651
mdprc 006 10 17 000The Metrix CoSECURE(R) 100mL EMPTY VINYL CONTAINER With 2 Portshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158688
mdprc 005 10 17 000Deerfield ImagingHead Fixation Device (HFD100) Starburst adaptor thumb screwhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158467
mdprc 004 10 17 000Firefly Medical, IncIVEAhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158512
mdprc 003 10 17 000Teleflex MedicalLMA(TM) MADgic(TM) LaryngoTracheal Mucosal Atomization Deviceshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158408
mdprc 002 10 17 000Zimmer BiometDrill Bit QuickConnecthttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156023
mdprc 001 10 17 000Zimmer BiometEndosseous Dental Implant Accessorieshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158315
mdprc 050 09 17 000FUJIFILM CorporationVarious Duodenoscopes ,.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154542
mdprc 049 09 17 000Baxter Corp CanadaBaxter Amia Automated Peritoneal Dialysis Set with Cassettehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158638
mdprc 048 09 17 000Becton Dickinson & Co. (BD)BD Needle 22GA 11/2in SafetyGlidehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157172
mdprc 047 09 17 000Boston ScientificFFR LinkFFR Signal Processing Modulehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156068
mdprc 046 09 17 000X-Laser LlcAurora, Caliente Aurora, PSX400, Mobile Beat Max, Mobile Beat Max MKII, Xbeam, and Hawk 500 modelshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158026
mdprc 045 09 17 000Zimmer BiometHerga foot switch, a component of ROSA Surgical Devicehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156850
mdprc 044 09 17 000OrthofixFirebird NXG Spinal Fixation System Decorticating Planerhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158127
mdprc 034 09 17 000Organ Recovery SystemsSPS-1 Static Preservation Solutionhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151877
mdprc 029 09 17 000Toshiba Medical Systems CorporationUltimax Digital Fluoroscopic XRay Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157489
mdprc 028 09 17 000Merge Healthcare Corp.Merge Unity softwarehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157956
mdprc 007 09 17 000Encore Medical, LpTuron Glenoid Reamerhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158249
mdprc 006 09 17 000Beckman CoulterUniCel DxH Slidemaker Stainer Coulter Cellular Analysis Systems.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157861
mdprc 003 09 17 000Vyaire MedicalAirLife(TM) Arterial Blood Gas (ABG) Sampling Kithttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158028
mdprc 002 09 17 000Neusoft Medical System Co.NeuViz 64 Multislice CT Scanner System, NeuViz 128 CT Scanner Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156762
mdprc 001 09 17 000Master & Frank Enterprise Co LtdMEDLINE SIRUS Surgical Gown, Strong Protection, Poly-Reinforced, Breathable Film Sleevehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156974
mdprc 106 08 17 000Certified Safety Mfg Inc.Burn Sheet, sterile 60 x 96https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156722
mdprc 098 08 17 000Smiths Medical ASD Inc.CADD(R) Medication Cassette with clamp and female Luerhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156494
mdprc 097 08 17 000Medspira LLCmcompass Balloon 2-Channel Cathetershttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157691
mdprc 096 08 17 000Kentec Medical IncENFit(R) AMERITUS NG FEEDING TUBEhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157812
mdprc 095 08 17 000bioMerieux IncVITEK 2 Compact 15 and VITEK 2 Compact 30https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157918
mdprc 087 08 17 000Acumed LLCOPT Croutons synthetic bone substitutehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151650
mdprc 085 08 17 000Solta MedicalVASER Amplifiershttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157186
mdprc 084 08 17 000Custom Assemblies IncVarious custom surgical kitshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158352
mdprc 083 08 17 000Cardinal Health..Convertors Robotic Drape with Attached Leggings; Product is packaged as Single Sterile Drapehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158213
mdprc 082 08 17 000Alcon Research, LtdORA System with VerifEyehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157981
mdprc 065 08 17 000Randox Laboratories Ltd.IgE Calibrator Serieshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149667
mdprc 064 08 17 000Boston Scientific LtdVarious S-ICD Systemshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157929
mdprc 044 08 17 000CenorinThermaSure, a CENORIN product, 1000 Series, 130 Series, 300 Serieshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157002
mdprc 029 08 17 000ExactechManual Surgical Instrumenthttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156716
mdprc 028 08 17 000Valorem Surgical LLCMAXIMIS Pedicle Screw Spinal Fixation Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156169
mdprc 027 08 17 000Sorin GroupCardiopulmonary Bypass Catheter Cannula and Tubinghttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157559
mdprc 026 08 17 000GE HealthcareSIGNA, Brivo, Optima MRIhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156163
mdprc 025 08 17 000C R Bard Incleg baghttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157782
mdprc 024 08 17 000StrykerStroke Fast Packhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157439
mdprc 023 08 17 000Spectranetics CorporationRapid Exchange Turbo Elite Atherectomy Cathetershttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156104
mdprc 021 08 17 000Myelotec Inc. 2010 Video Guided Catheterhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156176
mdprc 118 07 17 000Smiths Medical ASD Inc..CADD BlueStriped Administration Sethttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157885
mdprc 117 07 17 000Fisher DiagnosticsPacific Hemostasis Fibrinogen Degradation Productshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155789
mdprc 116 07 17 000Cardinal Health..Converters(R) Tiburon(R) Arthroscopy Drapehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157506
mdprc 109 07 17 000GE Medical SystemsOEC 9800 and OEC 9900 Elitehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152098
mdprc 108 07 17 000Penumbra, Inc.3D Revascularization Deviceshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156554
mdprc 107 07 17 000PENTAX MedicalCart-Mounted Computer Systemshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155016
mdprc 106 07 17 000Medtronic SASpine Tools Install CDs Used with StealthStation S7 Systemshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155812
mdprc 105 07 17 000Medtronic SAVisualase Cooled Laser Applicator System 15 mm Tip Capshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156887
mdprc 093 07 17 000Mesa Laboratories, Inc.Conductivity/TDS Calibrator Solution.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155840
mdprc 092 07 17 000Flowonix MedicalPrometra II Programmable Pumpshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156065
mdprc 070 07 17 000Beckman Coulter UK LtdSynchron Systems AQUA Cal 1 Reagentshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155844
mdprc 069 07 17 000ICU Medical, IncStopcock, i.V. Sethttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156514
mdprc 068 07 17 000Merge Healthcare Corp.Schiller PB 1000 Used with Hemo Softwarehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154942
mdprc 067 07 17 000Natus NeurologyElite 2,Elite 3,Elite 5https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156547
mdprc 066 07 17 000Oscor Inc.Reusable ATAR Extension Cableshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154469
mdprc 065 07 17 000O-Two Medical Technologies, IncTimer, General Laboratoryhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156310
mdprc 064 07 17 000PENTAX Europe GmbHPentax Video Duodenoscopehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155670
mdprc 048 07 17 000Arrow International IncArrow Glide Thru PeelAway Sheath/Dilator Introducerhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156760
mdprc 047 07 17 000BD BiosciencesModel 8100 Alaris Pump Modules and Pump Module Door Latch Kitshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155608
mdprc 046 07 17 000ExactechTibial Augment Screwhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156193
mdprc 045 07 17 000Ion Beam Applications S.A.ProteusPlus, Proteus 235, Proton Therapy Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156863
mdprc 044 07 17 000Mallinckrodt AGTenaxis Medical ArterX(TM) Surgical Sealanthttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156110
mdprc 043 07 17 000Natus Medical Inc.Olympic Pasteurmatic 3000; Olympic Pasteurmatic 3500https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153196
mdprc 037 07 17 000SIEMENSVibe Sensis Systemshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155711
mdprc 017 07 17 000Ion Beam Applications S.A.Proteus 235 and Proteus ONE proton therapy systemshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156859
mdprc 016 07 17 000AGFA Corp.IMPAX Cardiovascularhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156955
mdprc 015 07 17 000bioMerieux Inc. VIDAS Testosteronehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155630
mdprc 014 07 17 000JAS Diagnostics Inc. Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156089
mdprc 013 07 17 0003M Health Care Ltd3M Ranger(TM) Pressure Infusorhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155950
mdprc 012 07 17 000Boston Scientific LtdImager II Angiographic Catheterhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154140
mdprc 011 07 17 000CryoLife, Inc.BioGlue Surgical Adhesivehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155852
mdprc 010 07 17 000Mindray DS USA, Inc.TI Transport Monitor/Module Battery Packhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155916
mdprc 009 07 17 000Onkos Surgical, Inc.ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEMhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156329

mdprc 083 06 17 000Depuy Orthopaedics, Inc. LATARJET EXPERIENCE Systems Instrumentshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155555
mdprc 082 06 17 000IBA Dosimetry GmbHProteus 235https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155167
mdprc 081 06 17 000Merge Healthcare Corp.Merge PACS software https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155551
mdprc 080 06 17 000Merge Healthcare Corp.Merge PACS software https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155552
mdprc 079 06 17 000Omega Medical Imaging, Inc.2 over 2 Elevating Monitor Suspension pillar/column accessoryhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156081
mdprc 078 06 17 000SIEMENSSOMATOM Perspective, SOMATOM Scope Power, and SOMATOM Scopehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151463

mdprc 077 06 17 000Teleflex MedicalSheridan SHER-I-SLIP and SOFT-TIP Intubating Styletshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155751
mdprc 076 06 17 000Z-Medica LLCQuikClot TraumaPadshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155692
mdprc 059 06 17 000Monica Healthcare Ltd.Uterine Electromyographic Monitorhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155680
mdprc 058 06 17 000Teleflex Medical..Various Arrow Arterial, CVC, Hemodialysis, MAC, PICC, and PSI Kits ,https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155537
mdprc 057 06 17 000GE HealthcareVarious CT, NM, and PET Scannershttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155861
mdprc 056 06 17 000Arrow International IncARROWgard Blue CVC, ARROW MAC TwoLumen Central Venous Access, Arrow Pressure Injectable PICC Kithttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155539
mdprc 047 06 17 000OrthoPediatrics CorpResponse BandLoc 5.5/6.0 Tensioner Instrumenthttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155589
mdprc 045 06 17 000Nexstim OYNexstim, NBS Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155420
mdprc 041 06 17 000GE HealthcareInfant Radiant Warmer.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155625
mdprc 040 06 17 000Depuy Orthopaedics, IncDePuy Synthes orthopedic instrumentshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151963
mdprc 027 06 17 000Magellan Diagnostics IncLeadCare Blood Lead Testing Systemshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155438
mdprc 026 06 17 000Laserex Systems IncTango Reflexhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155147
mdprc 025 06 17 000Circadiance LLCSmartMonitor 2 PS/PSL Monitorshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155172
mdprc 024 06 17 000Argon Medical DevicesClear Flashback and Winged Arterial Needleshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155591
mdprc 023 06 17 000Stryker CommunicationsBerchtold Chromopharehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155570
mdprc 017 06 17 000Orthosoft, IncSesamoid Plastyhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154865
mdprc 016 06 17 000Madison Polymeric EngineeringDraco Enzymatic DeepCleaning Pad with Enzymatic Detergenthttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155123
mdprc 015 06 17 000Cell Marque CorporationEstrogen Receptor (EP1)https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155439
mdprc 014 06 17 000Cardinal Scale Mfg CoCardinal, Digital Bariatric Scalehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154739
mdprc 013 06 17 000Baxter Transfer Sethttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153044
mdprc 005 06 17 000Vascular Solutions Incdolphin Inflation Devicehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154966
mdprc 004 06 17 000Toshiba American Medical Systems IncToshiba Angio WorkStation (XIDFAWS801)https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155327
mdprc 003 06 17 000Hans Pausch Rontgengeratebau GmbhPausch Medical Uroview FDhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154240
mdprc 002 06 17 000Acumed LLCAcumed SlideLoc Anatomic Radial Head Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154986
mdprc 001 06 17 000AbbVie Inc..AbbVie PEG, PEG Kit 15FR, 20FRhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155421
mdprc 148 05 17 000Zimmer BiometSpFXL IIB 2/DM and SpFPLUS Implantable Stimulatorshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154946
mdprc 147 05 17 000Medtest Holdings, IncPointe Scientific Lactate Dehydrogenase (Liquid) Reagenthttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154879
mdprc 146 05 17 000CORPAK MedSystems .CORFLO PEG Y Adapters with ENFit Connectorshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155499
mdprc 145 05 17 000Arrow International Inc.Arrow VPS Access Kithttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155122
mdprc 142 05 17 000Cardiovascular Systems, IncSaline Infusion Pumpshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154675
mdprc 138 05 17 000Implant Direct LLCHLA3-5 Legacy Full Contour Abutment Assemblieshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155149
mdprc 137 05 17 000Cardiovascular Systems, IncCSI, Orbital Atherectomy System (OAS) Saline Infusion Pumphttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154675
mdprc 136 05 17 000Bard Pcripheral Vascular (BPV)StatLock IV Premium Catheter Stabilization Devicehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155010
mdprc 135 05 17 000B Braun Medical IncElcam CytoGuard Closed Luer Connectorshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155027
mdprc 134 05 17 000Mesa Laboratories, Inc.Conductivity/TDS Calibrator Solutionhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155628
mdprc 133 05 17 000Bard Pcripheral Vascular (BPV)StatLock IV Premium Catheter Stabilization Devicehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155010
mdprc 132 05 17 000Cardiovascular Systems, IncCSI, Orbital Atherectomy System (OAS) Saline Infusion Pumphttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154675
mdprc 131 05 17 000Implant Direct LLCHLA3-5 Legacy Full Contour Abutment Assemblieshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155149
mdprc 127 05 17 000bioMerieux IncETEST Ceftriaxonehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155036
mdprc 126 05 17 000Cardiovascular Systems, Inc. Saline Infusion Pumpshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154675
mdprc 125 05 17 000Magellan Diagnostics Inc. Magellan Diagnostics LeadCare Ultra Blood Analyzerhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154783
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154782
mdprc 124 05 17 000Zimmer inc. NexGen Offset Stem Extensionhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155137
mdprc 113 05 17 000Medline Industries IncAnterior Cervical Distraction Pinshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152774
mdprc 112 05 17 000Ziehm Imaging GmbH.Ziehm Solo FDhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154847
mdprc 088 05 17 000Del Mar Reynolds MedicalArkon Anesthesia Delivery System.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154830
mdprc 087 05 17 000IBA Dosimetry GmbHProteus One, Proteus Plushttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154743
mdprc 076 05 17 000Vortran Medical Technology 1, IncVORTRAN Automatic Resuscitator, VARPlushttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154926
mdprc 075 05 17 000Stryker InstrumentsStryker PROFESShttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154817
mdprc 074 05 17 000Orthosoft, IncNavitrack System OS Knee Universal, Stereotaxic instrumenthttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154873
mdprc 073 05 17 000Ortho-Clinical DiagnosticsenGen Laboratory Automation Systems Using TCAutomation Software with InOut Communication Interfacehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154093
mdprc 072 05 17 000Mentor Texas IncSalineFilled SPECTRUM Breast Implantshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154428
mdprc 071 05 17 000Hitachi Medical CorpArietta70 Ultrasound Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154883
mdprc 070 05 17 000Eden MedicalGIZA Vertebral Body Replacementhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154405
mdprc 069 05 17 000Biomet MicrofixationBiomet Microfixation TraumaOne System Surgical Trayhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154834
mdprc 068 05 17 000Zimmer BiometRegenerex Series A Patella Pegs .https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154964
mdprc 067 05 17 000Stryker CommunicationsGaymar Medi-Therm Hypothermia Systemshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154824
mdprc 066 05 17 000Almore International IncMicrofil Composite Instrumentshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154721
mdprc 057 05 17 000Med-Hot Thermal Imaging, IncMEDHOT MTI 2000 THERMAL IMAGING SYSTEMMedhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153694
mdprc 056 05 17 000GREATBATCH MEDICALLinear Straight Broach Handle, (Rasp Handle) EZ Clean" Linear Broach Handlehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154992
mdprc 055 05 17 000The Anspach Effort, Inc.Table and attachments, operating-roomhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152393
mdprc 054 05 17 000Orthosoft, IncNDI P7 Position Sensor, Stereotaxic Instrumenthttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154878
mdprc 053 05 17 000Medtronic Sofamor DanekPAK NEEDLE BEVELED AND TROCAR TIPShttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154880
mdprc 052 05 17 000Mederi Therapeutics, IncMederi Stretta Catheter and Accessory Kithttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154736
mdprc 042 05 17 000Sysmex America IncSysmex XN Series Automated Hematology Analyzershttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154358
mdprc 041 05 17 000Smith & Nephew incPERILOC VOLAR DISTAL RADIUS RIGHT 3H STD HEAD LOCKING PLATEhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154604
mdprc 040 05 17 000Dale Medical Products, Inc.Dale Medical Stabilock Endotracheal Tube Holder, Adhesive Basehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154789
mdprc 039 05 17 000C R Bard IncGHIATAS Beaded Breast Localization Wireshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154553
mdprc 038 05 17 000Breg IncVarious Dressingshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154790
mdprc 037 05 17 000Boston Scientific.JETSTREAMhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154677
mdprc 033 05 17 000XTANT MEDICAL INCFortex Pedicle Screw Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154382
mdprc 032 05 17 000Ulrich GmbH & Co. KGuNion CPShttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154069
mdprc 030 05 17 000Sonesta MedicalSonesta S2https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154929
mdprc 029 05 17 000Savaria Concord Lifts, Inc.Omega Incline Platform Lift.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154907
mdprc 028 05 17 000Richard-Allan ScientificShandon Rapid Chrome KwikDiffhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154823
mdprc 027 05 17 000RemelBlood Agar (TSA with 5 Sheep Blood)https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154393
mdprc 026 05 17 000Orthosoft, IncNavitrack System OS Knee Universalhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154874
mdprc 024 05 17 000Medtronic SAHeartWare Ventricular Assist Device Controllers and Heart Ware 1435 DC Adaptershttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153628
mdprc 023 05 17 000Amendia, Inc Guide Wireshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154922
mdprc 013 05 17 000Ion Beam Applications S.A.Proteus Plushttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154230
mdprc 012 05 17 000Philips BurtonBrightView SPECT, XCT, X 3/4https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154006
mdprc 056 04 17 001Cardiovascular Systems, IncViperWire Advance Peripheral Guide Wire with Flex Tiphttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154580
mdprc 011 05 17 000Zimmer BiometSmartTools Knee Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153399
mdprc 010 05 17 000BD Diagnostic SystemsBD Viper LT software, version 3.00Hhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154526
mdprc 009 05 17 000Avid Medical, Inc.Vacutainer Tubeshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154076
mdprc 008 05 17 000Arrow International IncArrow gard Blue PLUS Central Venous Catheterhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154605
mdprc 007 05 17 000AngioDynamics IncNAMIC Fluid Delivery Sets ,https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152938
mdprc 006 05 17 000Alcon Research, LtdPackaged Kitshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154408
mdprc 072 04 17 000Signal Medical CorporationSoft Face "No Bounce" Mallethttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153400
mdprc 070 04 17 000Beckman Coulter IncAccess Ferritin Calibrators for Access Ferritin assay on the Access Immunoassay Systemshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154369
mdprc 069 04 17 000Keystone Dental IncKeystone Dental PrimaConnex Straight Implant TChttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154175
mdprc 068 04 17 000Intuitive Surgical IncDa Vinci Xi EndoWrist Suction Irrigators ,https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154548
mdprc 067 04 17 000Ferno-Washington IncFerno PROFlexx Model 28Z Chair Cothttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154113
mdprc 066 04 17 000Cincinnati Sub-Zero Products IncHemotherm CE, model 400CE, HeaterCooling Devicehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154013
mdprc 064 04 17 000Micromedics IncFibriJet Endoscopic Catheter Introducerhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151600
mdprc 063 04 17 000Hill-Rom, Inc. &SubsidiariesTotalCare Bed Systems with 3-Level Patient Position Monitoringhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153395
mdprc 062 04 17 000AesculapAESCULAP (FH620R) MINOP InVent 30 Trocar Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154132
mdprc 061 04 17 0002k Innovations IncVolt Resistancehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154190
mdprc 060 04 17 000Windstone Medical Packaging, Inc.Ophthalmic Packhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154151
mdprc 059 04 17 000Welch Allyn Protocol IncMicrolife ProBP 2400 Digital Blood Pressure Deviceshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153506
mdprc 058 04 17 000GE Medical SystemsGE Centricity Web Diagnostic (WebDx)https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116455
mdprc 057 04 17 000Draeger Medical Systems IncKappa, Delta, Delta XLhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154433
mdprc 055 04 17 000VOLCANO CORPORATIONREFINITYhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154474
mdprc 053 04 17 000Nihon Kohden CorpCSM1901https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154033
mdprc 052 04 17 000Merit Medical Systems IncPreludeSYNC Radial Compression Devicehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154106
mdprc 051 04 17 000Datascope CorpCustom Tubing Pack with Bioline Coatinghttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153411
mdprc 050 04 17 000PerkinElmer Life and Analytical SciencesSpecimen Gate Laboratoryhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153750
mdprc 038 04 17 000Centurion Medical ProductsOPHTHALMIC DRESSING TRAYhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154052
mdprc 037 04 17 000Agilent Technologies, Inc.Bond Elut Dried Matrix Spotting (DMS) cardshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153930
mdprc 036 04 17 000Philips HealthcareIntelliVue MX40 WLAN Patient Wearable Monitors.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153762
mdprc 035 04 17 000Philips Burton eCare Coordinatorhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153766
mdprc 033 04 17 000Arrow International IncARROW Antimicrobial/Antithrombogenic PICC Kitshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153712
mdprc 016 04 17 000United Orthopedic CorporationUOC Femoral driverhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153467
mdprc 015 04 17 000Medtronic SASynchroMed II implantable drug infusion pumphttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153615
mdprc 014 04 17 000Biomet 3i IncBIOMET 3i LTX DENTAL IMPLANTShttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154241
mdprc 013 04 17 000Zimmer incAltius MINI OCT Posterior Spinal Fixation Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153660
mdprc 012 04 17 000Strata Skin Sciences, Inc.XTRAC Excimer Laser, Model No. AL8000, AL10000https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153927
mdprc 011 04 17 000Nonin Medical, Inc.Nonin, 8500M Handheld Pulse Oximeterhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150238
mdprc 010 04 17 000Focus Diagnostics IncLegionella IFA Substrate Slidehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153688
mdprc 116 03 17 000Terumo Cardiovascular Systems CorporationLevel Sensor II Padshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153246
mdprc 115 03 17 000Tearscience, IncLipiFlowhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152977
mdprc 114 03 17 000StreckCytoChex BCThttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153381
mdprc 113 03 17 000Siemens Medical SolutionsSyngo.plaza Picture Archiving and communications systemshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153715
mdprc 111 03 17 000Philips HealthcareHeartStart MRx Monitor/Defibrillators ,.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153480
mdprc 110 03 17 000National Biological CorpHand Foot IIhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154038
mdprc 109 03 17 000Molded Products IncNonSterile Double DIN to DIN "Y" Connectorhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154105
mdprc 108 03 17 000Merit Medical Systems Inc7 Fr Prelude Short Sheath Introducershttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153619
mdprc 107 03 17 000Medical Components, Inc9.6F Plastic Dignity MidSized CT port w/PreAttached Silicone Catheterhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153698
mdprc 106 03 17 000Hitachi Medical CorpHitachi Echelon MRI Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152994
mdprc 105 03 17 000Teleflex MedicalRusch, Latex Free Robertazzi Airwayhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152601
mdprc 104 03 17 000Siemens Medical SolutionsARTISTE MV System, Mevatron M2/Primus Mid Energy and PRIMUS HI, ONCOR" Avantgarde, ONCOR" Expression, Impression and Impression plushttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153976
mdprc 103 03 17 000Revision Optics IncRaindrop Near Vision Inlayhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153166
mdprc 102 03 17 000Medtronic LimitedPoly Component Trial, CRhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153924
mdprc 101 03 17 000Crossroads Extremity Systems LlcMotoCLIP(TM) Super Elastic Fusion Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153844
mdprc 100 03 17 000Zimmer BiometOrthosize Templatinghttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153219
mdprc 099 03 17 000Stanley Healthcare SolutionsArial WaterResistant Pendant, model 59350http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152047
mdprc 098 03 17 000Philips HealthcareBrilliance BigBore Radiology CThttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153825
mdprc 097 03 17 000Merge Healthcare Corp.Merge Cardio with Issuer Patient ID ( IPID)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154005
mdprc 096 03 17 000GE HealthcareElectri-Cord Power Cords Used with Various Incubators, Warmers, and Exam Lights:http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152634
mdprc 096 12 16 001Vygon UK LtdVygonhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153644
mdprc 085 03 17 000Acumed LLCGuide Wirehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153524
mdprc 084 03 17 000Toshiba Medical Systems CorporationToshiba Kalare DREXKL80, Ultimax DREXULT80http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152450
mdprc 083 03 17 000Smiths Medical International LimitedBivona TTS (Tight to Shaft) Pediatric Tracheostomy Tubehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153205
mdprc 082 03 17 000Maquet Cardiopulmonary AGVASOVIEW HEMOPRO VH-3500 Endoscopic Vessel Harvesting Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152788
mdprc 081 03 17 000Del Mar Reynolds Medical, Ltd.Arkon Anesthesia Delivery Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153199
mdprc 022 11 15 001Encore Medical, LpRSP and Turon Impaction Fixtureshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153244
mdprc 057 03 17 000CORENTEC CO., LTDBencox Mirabo PE Liner 36/44http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153590
mdprc 056 03 17 000Smiths Medical ASD Inc..CADD Solis VIPhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152490
mdprc 055 03 17 000Siemens Medical SolutionsPRIMUS HI, MEVATRONhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153261
mdprc 054 03 17 000RTI Surgical, IncRTI Biologics BioSet IC RT Paste 2 cchttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153287
mdprc 110 02 17 001Phadia LtdRecall EliA Sample Diluenthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152965
mdprc 033 03 17 001Parker HealthcareParker Left Double Lumen Endobronchial Tube with Parker FlexTiphttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00258-1
mdprc 035 03 17 000The See Clear CompanyDiamond, Fierce, Ambition, Circle Collection, Lunatic, Fright, Desire and See Clearhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152629
mdprc 034 03 17 000RemelHaemophilus Test Mediumhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153231
mdprc 032 03 17 000MicroAire Surgical Instruments.MicroAire K-Wireshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153520
mdprc 031 03 17 000Metrex Research, LLCCaviWipes1 Extra Largehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152763
mdprc 030 03 17 000Medtronic SARF Surgical Systems Sterile Drapeshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152794
mdprc 019 03 17 000Mckesson Information Solutions LLCMcKesson Radiology 12.2 Picture Archive Communication Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153379
mdprc 018 03 17 000Ergosafe Products LLCA-series lift - A625http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153404
mdprc 010 03 17 000Windstone Medical Packaging, Inc.Gloveshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152631
mdprc 009 03 17 000Synthes GmbHPRODISChttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153344
mdprc 008 03 17 000Matrix SurgicalOMNIPORE Surgical Implant Design Y Mandible Onlayhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152960
mdprc 112 02 17 000Roche Diagnostics LtdCobas b 123 POC systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151082
mdprc 111 02 17 000Vascular Solutions IncGrebSet MicroIntroducer Kithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152975
mdprc 109 02 17 000OlympusUretero-Reno Fiberscopeshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151898
mdprc 108 02 17 000Smith & NephewDyonics Saw Bladehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153146
mdprc 107 02 17 000Quidel CorporationInfluenza Transport Swabhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152840
mdprc 106 02 17 000Degania Silicone, LtdJackson Pratt" Channel drainhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152988
mdprc 105 02 17 000Custom Medical Specialties, IncCMS2193R7 and CMS1911R3 Custom Biopsy Trayhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152617
mdprc 104 02 17 000Cardiovascular Systems, IncDIAMONDBACK 360 Peripheral Orbital Atherectomy Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152955
mdprc 103 02 17 000Biomet IncOxford Partial Knee Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=152481
mdprc 102 02 17 000Arrow International IncArrow PICC Kits with Peel-Away Sheath Componenthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152569
mdprc 078 02 17 000Zimmer BiometCranio-maxillofacial Bone Screwshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152996
mdprc 077 02 17 000Tosoh CorporationTosoh Bioscience HLC723G8 Analyzerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151106
mdprc 076 02 17 000Philips HealthcareInfiniBand Cables Used with Cisco 3850 Layer 3 Switches Used with IntelliVue Information Center iX or Classic Information Centershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152105
mdprc 075 02 17 000Biomet IncVanguard Kneehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152728
mdprc 074 02 17 000AngioDynamics IncCelerity PICC Tip Confirmation Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149720
mdprc 053 02 17 000Argon Medical Devices IncBone Needlehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152717
mdprc 052 02 17 000Acumed LLC6-hole Pubic Symphysis platehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152823
mdprc 051 02 17 000Integra LifeSciencesIntegra Cadence Total Ankle Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152681
mdprc 050 02 17 000Encore Medical, LpLIMA Modular Revision Hip Stemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152523
mdprc 034 02 17 000Vertebral Technologies, Inc InterFuse Tail Traction Toolhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152615
mdprc 033 02 17 000Teleflex MedicalSheridan HVT, Cuffed, Uncuffed Tracheal Tubehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152271
mdprc 032 02 17 000Merge Healthcare Corp.Merge RadSuite softwarehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152597
mdprc 031 02 17 000Ortho-Clinical DiagnosticsVITROS Immunodiagnostichttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147282
mdprc 030 02 17 000Physio Control IncLIFEPAK 12, LIFEPAK 15 Defibrillator/Monitorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152423
mdprc 017 02 17 000Mevion Medical Systems, Inc.MEVION S250-Proton Radiation Therapyhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152138
mdprc 016 02 17 000Medtronic Advanced Energy, LLCIntact Disposable Wandshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152248
mdprc 015 02 17 000AngioDynamics IncCelerity PICC Tip Confirmation Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149720
mdprc 009 02 17 000Siemens Medical SolutionsSyngo.plaza, picture archiving and communications systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152622
mdprc 124 01 17 000Zimmer incOrthopedic Salvage System (OSS) 9cmhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152112
mdprc 123 01 17 000Implant Direct LLCSwishTapered Implanthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152174
mdprc 122 01 17 000Flower Orthopedics CorporationCannulated Drill bit 2.0mm and 2.6 mmhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152401
mdprc 121 01 17 000Smiths MedicalNORMOFLO H1100 Irrigation Fluid Warmershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152491
mdprc 120 01 17 000SCC Soft ComputerSoftbank IIhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152048
mdprc 119 01 17 000PerkinElmer Life and Analytical SciencesSpare Disk Remover Modulehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152448
mdprc 118 01 17 000Hitachi Medical CorpHitachi Oasis MRI System CSpine Coilhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152058
mdprc 117 01 17 000Biom'upRENOVIX Guided Healing Collagen Membranehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152768
mdprc 107 01 17 000Baxter HealthcarePhoenix Monitorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152438
mdprc 106 01 17 000Acumedia Manufacturers, IncNeogenhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152054
mdprc 105 01 17 000Roche Diagnostics CorpTinaQuant (Latex) HS Test System (CReactive Protein (Latex) High Sensitive)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151085
mdprc 097 01 17 000Sekisui DiagnosticsAmmonia L3K Assayhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151386
mdprc 096 01 17 000PENTAX Europe GmbHPentax Rigid Laryngostroboscopeshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152137
mdprc 095 01 17 000Medtronic Navigation IncTouch N Go pointerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152061
mdprc 094 01 17 000Medline Industries IncE-Z Lubricating Jellyhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151810
mdprc 093 01 17 000INO Therapeutics (dba Ikaria)INOmax DSIR Plus delivery systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151520
mdprc 092 01 17 000Philips BurtonBrilliance iCThttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152295
mdprc 091 01 17 000On-X Life Technologies, IncChordX Chordal Sizerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151822
mdprc 090 01 17 000The Binding SiteDigital RID Plate Readerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152040
mdprc 089 01 17 000Great Basin Scientific, IncGreat Basin Staph lD/R Blood Culture Panelhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152100
mdprc 088 01 17 000DICOM GRID INCAmbra PACShttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152488
mdprc 087 01 17 000Carestream HealthCarestream Touch Prime and Carestream Touch Prime XEhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152532
mdprc 086 01 17 000CareFusion..Model 8100 Alaris Pump Modules and Air-in-Line Sensor Kitshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150442
mdprc 085 01 17 000Bard Pcripheral Vascular (BPV)Halo One ThinWalled Guiding Sheathhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151513
mdprc 075 01 17 000Zimmer incArComXL Polyethylene Bearings and Linershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151858
mdprc 074 01 17 000Ultradent Products, IncNanoTipshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152022
mdprc 073 01 17 000Stryker Howmedica Osteonics CorpReunion TSA Peg Alignment Sound, Stryker Orthopaedicshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151592
mdprc 072 01 17 000Fresenius Medical Care.Fresenius Home Dialysis Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152020
mdprc 071 01 17 000ExactechAlteon Neck Preserving Stem, AcuMatch ASeries Connexion GXL Enhanced Polyethylene Acetabular Liner, Novation Cemented Plus Femoral Stemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151892
mdprc 070 01 17 000Health Roboticsi.v.STATION ONCO Automated Drug Compounding Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152440
mdprc 069 01 17 000ConforMISiTotal PS Knee Replacement Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151856
mdprc 068 01 17 000Bard Access SystemsSafeStep Huber Needle Set with YInjection Site and MiniLoc Safety Infusion Set Winged without YInjection Sitehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151928
mdprc 060 01 17 000Alcon Research, LtdAlcon Monarch III (1) "C" Cartridgehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149191
mdprc 059 01 17 000Amendia, IncCeres-C Standalone Cervical Interbodyhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151460
mdprc 058 01 17 000Advanced Sterilization ProductsEVOTECH Endoscope Cleaner and Reprocessor System 208V,http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149985
mdprc 057 01 17 000Implant Direct LLCGoDirect Screw-Retaining Tophttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151437
mdprc 051 01 17 000Trilliant Surgical LtdTiger Cannulated Screw Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151974
mdprc 048 01 17 000In2Bones, SASDRP SCREWhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152164
mdprc 047 01 17 000Natus Medical Inc.Warmette Blanket Cabinet and Warmette Dual Cabinethttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151447
mdprc 046 01 17 000VocoVOCO Futurabond M adhesivehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151254
mdprc 035 01 17 000Infraredx, Inc.TVC Imaging System model TVC-MC9http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151938
mdprc 034 01 17 000Pride Mobility Products LtdTRU-Balance 3 Power Positioning Systems, TB3 Lift/Tilt/Recline (Gen 1).http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151534
mdprc 033 01 17 000Tepha IncorporatedGalaSHAPE 3Dhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151792
mdprc 032 01 17 000Merit Medical Systems IncPreludeEASE Dilators Used with 6 Fr PreludeEASE Hydrophilic Sheath Introducershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151906
mdprc 031 01 17 000AesculapGomco Circumcision Clamps with separate ORinghttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151777
mdprc 124 12 16 000Neusoft Medical System CoNeuViz 128, NeuViz 64http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150175
mdprc 123 12 16 000Synthes IncSynthes VA Implant Rack for the Compact Distal Radius Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151426
mdprc 122 12 16 000Stryker CommunicationsMIS (Minimally Invasive Surgery) Toolsteel Burshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151387
mdprc 121 12 16 000Owens & MinorArm Slinghttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150987
mdprc 120 12 16 000PerkinElmer Life and Analytical SciencesSpecimen Gate Laboratory eReportshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151383
mdprc 119 12 16 000NorthgateInsufflator, laparoscopichttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151095
mdprc 118 12 16 000Medtronic Advanced Energy, LLCPowerCross .018 OTW PTA Dilation Catheterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151248
mdprc 112 12 16 000Philips Medical SystemsBrilliance and Ingenuity Computed Tomography Xray system..http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142085
mdprc 097 12 16 000Medtronic Advanced Energy, LLCSynchroMed II Implantable Drug Infusion Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150480
mdprc 095 12 16 000Teleflex MedicalRUSCHhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151249
mdprc 094 12 16 000Natus Medical Inc. Natus neoBLUE blanket LED Phototherapy systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147989
mdprc 093 12 16 000Firefly Medical, IncIVEA 500Ahttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150828
mdprc 084 12 16 000Stryker Sustainability SolutionsReprocessed Xcel Bladeless Trocarhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151030
mdprc 083 12 16 000Roche Diagnostics LtdRoche Molecular Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151271
mdprc 082 12 16 000PENTAX Europe GmbHUltrasound Video Bronchoscopehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149791
mdprc 081 12 16 000Olympus Winter & IBE GmbHHF Cable WA00014Ahttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150883
mdprc 080 12 16 000Oculus Innovative Sciences IncCeramax Skin Barrier Cream, FROWound cleanser/ Dressing, wound, drughttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151214
mdprc 079 12 16 000Inovo, IncPurefill Oxygen Compressor, model PF1100http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150020
mdprc 078 12 16 000Covidien LLCCovidien Precision Specimen Containershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150473
mdprc 071 12 16 000PerkinElmer Life and Analytical SciencesPipette tips, Perkin Elmer RoboRackhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150563
mdprc 070 12 16 000Steris CorpHarmony Insight Diagnostic Monitor Support Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150180
mdprc 069 12 16 000GF Health ProductsPatriot Full Electric Homecare Beds, Patriot LX Full Electric Homecare Bedshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150433
mdprc 068 12 16 000Cook MedicalSpectrum Minocycline/Rifampin Impregnated Central Venous Catheter Trayshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151288
mdprc 067 12 16 000Becton Dickinson & Co. (BD)BD Spinal Anesthesia Trayhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151303
mdprc 053 12 16 000SynCardia Systems IncSynCardia Freedom Driver Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150882
mdprc 052 12 16 000Randox Laboratories LtdMagnesium Assays used with Rx Imola Analyzershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149845
mdprc 051 12 16 000Prism Medical LtdC-Series Ceiling Lifts Carry Barshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147755
mdprc 050 12 16 000Halyard Health Co.C-Section Drape with Clear Screen or Pouchhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151051
mdprc 048 12 16 000Elekta CMS SoftwareMOSAIQ Oncology Information System..http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151455
mdprc 047 12 16 000OlympusVANTA Analytical X-Ray Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150838
mdprc 040 12 16 000Merge Healthcare Corp.eFilm Workstation and eFilm Litehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149867
mdprc 039 12 16 000Ivoclar Vivadent AGVirtual XDhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150948
mdprc 038 12 16 000DeRoyal Europe LtdTENNIS ELBOW SUPPORT, PneuGel(TM),http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151016
mdprc 037 12 16 000AngioDynamics IncBioFlo PICC with ENDEXO and PASV Valve Technology Maximal Barrier Nursing Kit and Xcela Power Injectable PICC Maximal Barrier Nursing Kithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150100
mdprc 036 12 16 000AngioDynamics Inc. Peripherally Inserted Central Catheters (PICC)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148877
mdprc 028 12 16 000Thayer Intellectual Property, Inc.MANOS EXhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150962
mdprc 027 12 16 000Tornier Inc. Aequalis Fx2http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150330
mdprc 026 12 16 000Terumo BCT Inc. Adiprep Adipose Transfer Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150857
mdprc 025 12 16 000Sorin GroupSTOCKERT HeaterCooler System 3Thttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150831
mdprc 024 12 16 000Elana Inc. Elana Surgical KitHUDhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150965
mdprc 022 12 16 000Domain Surgical, Inc.FMsealer Open Shearshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150959
mdprc 021 12 16 000DePuySynthesStryker J-Latch Drill Bitshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151063
mdprc 004 12 16 000Spectranetics CorporationELCA Coronary and Turbo Elite Atherectomy Cathetershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150921
mdprc 003 12 16 000SIEMENSZ6Ms transesophageal transducers used on ACUSON SC2000 ultrasound systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150975
mdprc 002 12 16 000Hamilton Medical Inc. Hamilton-MR1 Ventilatorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150064
mdprc 167 11 16 000Roche Diagnostics LtdHandheld Base Unit for CoaguChek XS Plus and CoaguChek XS Pro Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150869
mdprc 166 11 16 000Lsi Medience CorporationPathfast D-Dimerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150602
mdprc 165 11 16 000Hologic Inc.SureSound + Uterine Sound Device Multipackshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150787
mdprc 164 11 16 000DePuy International LtdACTIS Flex Reamershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150760
mdprc 163 11 16 000ConforMISConforMIS iTotal Cruciate Retaining (CR) Knee Replacement Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150776
mdprc 162 11 16 000Cincinnati Sub-Zero Products Inc. The Hemotherm 400CEhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150976
mdprc 161 11 16 000Bausch & Lomb Inc.PeroxiClear Peroxide Solutionhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150049
mdprc 154 11 16 000Merit Medical Systems Inc. Custom Fluid Management Sethttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149111
mdprc 153 11 16 000Trilliant Surgical LtdTiger Large Cannulated Headless Screw Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149612
mdprc 152 11 16 000SorinORCHESTRA Programmer and ORCHESTRA PLUS Programmerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150425
mdprc 151 11 16 000SIEMENSSOMATOM Definition AS, SOMATOM Definition Flash and SOMATOM Definition Edgehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=151034
mdprc 150 11 16 000Mevion Medical Systems, Inc.MEVION S250 Radiation Therapy Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150527
mdprc 149 11 16 000Merge Healthcare Corp.Merge RadSuitehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149859
mdprc 148 11 16 000DePuy Spine, Inc.SKYLINE Variable and Constrained Screwshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150407
mdprc 147 11 16 000C R Bard Inc. Magic3 Antibacterial Hydrophilic Intermittent Catheterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150148
mdprc 146 11 16 000Alphatec Spine Inc.Set Screws Used with Arsenal Spinal Fixation Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150094
mdprc 145 11 16 000AlereAlere Triage Total 5 Control Level 1http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150328
mdprc 133 11 16 000Reshape Medical Inc. ReShape Integrated Dual Balloon Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150463
mdprc 131 11 16 000Bayer Healthcare LLC.MEDRAD Intego PET Infusion Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150186
mdprc 130 11 16 000StrykerReprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophysiology Cathetershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150221
mdprc 129 11 16 000Medline Industries Inc.Rigid Suction Canister 3000 CC and 2000 CC.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149428
mdprc 128 11 16 000Akita Sumitomo Bakelite Co., Ltd.SB (Sumitomo Bakelite Co.,) Electrosurgical Knifehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150181
mdprc 102 11 16 000Arrow International IncHANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow IPTD thermodilution catheter enclosed in a contamination shield (Arrow Cath-Gard) with integral flushing/balloon test chamber.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150156
mdprc 101 11 16 000Azer Scientific, Inc.Glucose Tolerance Beverage, Fruit Punch Glucosehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149271
mdprc 100 11 16 000B Braun Medical IncHospira 5% Lidocaine Hydrochloride and 7.5% Dextrose Injections Contained in Custom Spinal Anesthesia Trayshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148668
mdprc 099 11 16 000Spacelabs Healthcare IncModel 96102 Xhibit Central Stationshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150467
mdprc 092 11 16 000TEM Systems Incex-TEM Assay for ROTEM delta Thromboelastometry Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149847
mdprc 090 11 16 000Epimed International Inc15 G R.K. Epidural Needleshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=145925
mdprc 088 11 16 000Medtronic IncVisualase Visualization Stylets and Body Accessory Kitshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149419
mdprc 086 11 16 000BBI SolutionsSimpliRED D-Dimer Reagentshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148459
mdprc 061 11 16 000US EndoscopyVari-Safe Injection Needlehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147998
mdprc 060 11 16 000TZ Medical Inc.Neptune Plus (Hemostatic Pad)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148503
mdprc 059 11 16 000Ortho-Clinical DiagnosticsEnGen Laboratory Automation Systems Configured with Thermo Scientific Centrifuge Moduleshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149527
mdprc 058 11 16 000OlympusOER-Pro Automated Endoscope Reprocessorshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147873
mdprc 053 11 16 000Tearscience, IncLipiFlow thermal Pulsation Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149494
mdprc 052 11 16 000Synergetics Inc. 25 gauge VersaVit 2.0 Core Essentials Procedure Packhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148781
mdprc 051 11 16 000Osteogenics Biomedical, Inc.Cytoplast Titanium-Reinforced Posterior Singles Membranehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149396
mdprc 050 11 16 000Hand Biomechanics Lab Inc. Agee- WristJack Fracture Reduction System;http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149824
mdprc 049 11 16 000Becton Dickinson & Co. (BD)CD79b PE (ASR)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149794
mdprc 048 11 16 000Zimmer Inc.Uniflex Humeral Nailshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149723
mdprc 047 11 16 000Zimmer incThe Phoenix Femoral Nail System .http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149728
mdprc 028 11 16 000Winco, Inc.TransMotion Stretcher Chairhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148797
mdprc 027 11 16 000Medtronic SAMedtronic Navigation O-arm O2 Surgical Imaging Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149921
mdprc 026 11 16 000BOMImed Inc. Introes Pocket Bougieshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149464
mdprc 025 11 16 000Becton Dickinson & Co. (BD)V. Mueller Sterile Distraction Screwshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149995
mdprc 024 11 16 000Banyan Medical, LLC5 x 55mm Pyramidal Tip Trocarhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149913
mdprc 023 11 16 000Zimmer Inc. LDR Spine ROI-A Anterior Delivery Deviceshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149274
mdprc 022 11 16 000Toshiba Medical Systems CorporationAquilion and Celesteion CT Scannershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148646
mdprc 021 11 16 000Teleflex MedicalGripper Graspers and Johans Graspershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149434
mdprc 020 11 16 000Siemens Medical SolutionsSymbia T and Symbia S Series CThttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122573
mdprc 019 11 16 000Natus Medical IncorporatedNatalCare ST-LX Incubatorshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148064
mdprc 018 11 16 000Argon Medical Devices Inc. MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149676
mdprc 167 10 16 000Zimmer Biomet, Inc.Vanguard 360 Revision Knee System http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149732
mdprc 165 10 16 000Teleflex MedicalWilly Rusch GmbH Tracheostomy Tube Sethttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149196
mdprc 164 10 16 000Merit Medical Systems IncMerit Inflation Syringehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149424
mdprc 163 10 16 000HeartWare IncHeartWare Ventricular Assist System Controller http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146078
mdprc 162 10 16 000Sorin GroupAortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballonhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148853
mdprc 158 10 16 000Arrow International Inc.Walrus Arterial Embolectomy Catheterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149374
mdprc 157 10 16 000Philips HealthcareVarious Brilliance and Ingenuity Computed Tomography Systems..http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140467
mdprc 156 10 16 000Medtronic CareLink iPro Version 1.10http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148899
mdprc 130 10 16 000Zyno Medical LLCZyno Medical Administration Sethttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148698
mdprc 129 10 16 000EKOS CorpEkoSonic Endovascular System Cartshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149355
mdprc 128 10 16 000Microgenics Corp.DRI Salicylate Serum Tox Assayhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148620
mdprc 127 10 16 000Trividia Health (formerly Nipro Diagnostics)TRUEread , TRUEtrack , TRUEbalance and TRUEtest Blood Glucose Test Stripshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148492
mdprc 110 10 16 000Philips Medical SystemsBrilliance CT System, Big Bore Configurationhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129644
mdprc 109 10 16 000SIEMENSSyngo Plaza picture archiving and communication system http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149421
mdprc 106 10 16 000SIEMENSSyngo.x and Syngo.via picture archiving and communication systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149459
mdprc 104 10 16 000TriMed OrthoSemi-Tubular Plateshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149324
mdprc 103 10 16 000Sorin GroupStockert S5 Heart-Lung Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149150
mdprc 102 10 16 000OrthoPediatrics Corp3.5mm Bowed Locking Compression Femur Plateshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149114
mdprc 101 10 16 000Ortho SolutionsFPS 35mm x 3.5 mm non-locking screwhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148595
mdprc 100 10 16 000Integra LifeSciencesPHS Spinal Tray 24G Gertie Marxhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149139
mdprc 099 10 16 000Hologic Inc. Sertera Biopsy Devicehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149028
mdprc 076 10 16 000Merge Healthcare CorpRadSuite softwarehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148661
mdprc 075 10 16 000C R Bard Inc. Option-vm and Option-vf Urinary Cathetershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148280
mdprc 074 10 16 000Alcon Laboratories Inc.LAUREATE World Phaco Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148531
mdprc 073 10 16 000AirStrip Technologies, Inc.The Sense4Baby Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148904
mdprc 072 10 16 000AirStrip Technologies, Inc.The Sense4Baby Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148904
mdprc 063 10 16 000Thermo Fisher Scientific Inc.Endura MR Mass Spectrometerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148564
mdprc 062 10 16 000Mentor Texas Inc.CPX4 and Artoura Breast Tissue Expanderhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148715
mdprc 061 10 16 000T2 BiosystemsT2Candida Cartridgeshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148334
mdprc 060 10 16 000Stryker Howmedica Osteonics T2 Femoral Nailing System and T2 Supracondylar Nail Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148300
mdprc 059 10 16 000Stryker Howmedica Osteonics CorpStryker AccuLIF PL Cageshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148845
mdprc 009 10 16 000Sysmex America Inc. Fluorocell PLT Hematology Reagents Used with XN-Series Automated Hematology Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148122
mdprc 008 10 16 000Integra LifeSciencesIntegra Meshed Dermal Regeneration Templatehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144759
mdprc 007 10 16 000Hologic Inc.SureSight Obturator Introducer Localization System Sets Used with ATEC Breast Biopsy Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148567
mdprc 006 10 16 000Arrow International Inc.Multiple Arrow cathetershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148712
mdprc 049 09 16 000Zimmer Inc. Coonrad/Morrey Elbow Pin/Bushing Replacement Kitshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149116
mdprc 048 09 16 000Riverpoint Medical, LLCNylon Surgical Suture and Polypropylene Surgical Sutureshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148695
mdprc 047 09 16 000Novadaq Technologies Inc.SK6000 PAQ Sterile Drape Pouches Used with SPY Fluorescence Imaging Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149092
mdprc 046 09 16 000Hill RomAffinity Four Birthing Bedhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148397
mdprc 045 09 16 000Blackrock MicrosystemsNeural Signal Amplifiers and Patient Cables Used with NeuroPort Biopotential Signal Processing Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148706
mdprc 044 09 16 000Aspen Surgical Products, Inc.Bard-Parker 12B Conventional Stainless Steel Surgical Bladeshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147986
mdprc 031 09 16 000Mentor Texas Inc.MENTOR 2" Tall Height TE With Sutures 350cchttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148700
mdprc 030 09 16 000Integra LifeSciencesIntegra Cranial Access Kitshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149138
mdprc 029 09 16 000TopconPASCAL Synthesishttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148296
mdprc 028 09 16 000Merge Healthcare Corp.Merge Cardio softwarehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149136
mdprc 027 09 16 000Elekta LimitedPrecise Digital Accelerator http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=149195
mdprc 011 09 16 000Terumo Cardiovascular SystemsTerumo Custom Cardiovascular Kitshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148609
mdprc 009 09 16 000Medical Vision AbDouble Pump RF Patient Cassettehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146681
mdprc 008 09 16 000MindrayA7 Anesthesia Delivery Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148395
mdprc 006 09 16 000Integra LifeSciencesINTEGRA Spinal Trayhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148639
mdprc 005 09 16 000Philips HealthcarePower Supplies Used with PCR Compano Basic Digital Imaging Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148782
mdprc 003 09 16 000Hitachi Medical CorpHitachi Scenaria Computed Tomography Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148276
mdprc 002 09 16 000DeRoyal Industries Inc.CYSTO TRAYhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148841
mdprc 001 09 16 000Novarad CorporationNovaPACShttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148855
mdprc 148 08 16 000Bovie Medical CorporationBovie Precise 360 Handpiecehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148466
mdprc 147 08 16 000Ziehm Imaging GmbH.Ziehm Vision RFD, Vision RFD Mo, Vision RFD 3D, Vision2, Solo and Vision R Mobile C-arm for Mobile Fluoroscopic Imaginghttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=145913
mdprc 131 08 16 000GE HealthcareOEC UroView 2800 and OEC 9800http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148502
mdprc 130 08 16 000Stryker Instruments.120 V Neptune 3 Roverhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148396
mdprc 129 08 16 000Merge Healthcare Corp.RadSuite softwarehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148776
mdprc 128 08 16 000American National Mfg IncPanacea Air Pro Mattress Control Unithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148350
mdprc 127 08 16 000MedtronicLead Kit for DBS Stimulationhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147876
mdprc 126 08 16 000Richard Wolf GmbHConical portio adapter (acorn)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148125
mdprc 125 08 16 000AlereAlere INRatio and INRatio2 PT/INR Home Monitoring Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148145
mdprc 123 08 16 000Encore Medical, LpCobalt HV Bone Cement .http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148478
mdprc 092 08 16 000ResMed SAQuattro Air FFM MED AMERhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148349
mdprc 091 08 16 000OraSure Technologies, Inc.OraQuick Ebola Rapid Antigen Testhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148583
mdprc 090 08 16 000Merge Healthcare Corp.Merge Unity Z3D softwarehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148592
mdprc 089 08 16 000GE HealthcareGE Centricity PACS Workstationhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117066
mdprc 088 08 16 000CepheidXpert MRSAhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148487
mdprc 087 08 16 000Teleflex MedicalWeck EFx Classic Fascial Closure Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148177
mdprc 086 08 16 000Straumann USA, LLCStraumann Bone Level Implanthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148476
mdprc 085 08 16 000Medtronic Cardiovascular Revascularization & Surgical TherapTRYX Neuro Absorbable Antibacterial Envelopehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148164
mdprc 084 08 16 000Danville Materials, IncPerioscopy Sheathhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147855
mdprc 083 08 16 000Stryker Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lockhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148055
mdprc 082 08 16 000ColoplastGenesis Malleable Penile Prosthesishttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135724
mdprc 074 08 16 000Integra LifeSciencesIntegra External Fixation System Slotted Post and Universal Wire Fixation Bolthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148491
mdprc 073 08 16 000Halyard Health Co.Coolife Sinergy Radiofrequencyhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147894
mdprc 068 08 16 000Teleflex MedicalServo Humidifier 163http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148176
mdprc 059 08 16 000Richard-Allan Scientific10% Neutral Buffered Formalinhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147901
mdprc 058 08 16 000SIEMENSArtis zee/ zeego, Artis Q/ Q.zen, stand alone system.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148124
mdprc 057 08 16 000Dako Denmark A/SEnVision FLEX+, Mouse, High pH (Link)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148026
mdprc 056 08 16 000Teleflex MedicalHorizon 24 Large Titanium Clips with Adhesive Backinghttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148156
mdprc 054 08 16 000StrykerSpirit Select and Spirit Plus A-C powered hospital bedshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148254
mdprc 047 08 16 000Cardinal Health6F/7F MynxGrip Vascular Closure Devicehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148244
mdprc 016 08 16 000Implant Direct Sybron Manufacturing, LLCRePlant Angled Abutmenthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148061
mdprc 005 08 16 000Smith & NephewREFLECTION Spherical Head Screwhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148051
mdprc 004 08 16 000OlympusAnalytical X-Ray Fluorescence Systems of model family Deltahttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148001
mdprc 003 08 16 000Moller VitalMolift Air 205, Molift Air 205 Propulsion, Molift Air IRC, Molift Air 205 IRC Propulsion, Molift Air 300, Molift Air 300 Propulsion, Molift Air 300 IRC, Molift Air 300 IRC Propulsionhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147850
mdprc 002 08 16 000Merge Healthcare Corp.Merge PACShttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148106
mdprc 001 08 16 000GE HealthcareImagecast PACS with Centricity RIS-IChttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117002
mdprc 158 07 16 000The Anspach Effort, Inc.Anspach G1 High Speed Electric Handpiece Air Cooled (eG1A)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147607
mdprc 157 07 16 000Ortho-Clinical DiagnosticsVITROS Chemistry Products Ca Slideshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147262
mdprc 156 07 16 000GE Inspection TechnologiesPhoenix vtomex m240 cabinet x-ray systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147897
mdprc 155 07 16 000CareFusion DIAMOND-FLEX CIRCULAR RETRACTORhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147639
mdprc 154 07 16 000BEST THERATRONICS LTDBest Theratronics cabinet x-ray systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148078
mdprc 153 07 16 000BD BiosciencesBD Trucount Tubes.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147864
mdprc 152 07 16 000Zimmer BiometTSP Hip Fracture Plating Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147936
mdprc 150 07 16 000WalkMed Infusion, LLCTriton Infusion Pump and Triton FP Infusion Pumphttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147529
mdprc 149 07 16 000Toshiba Medical Systems CorporationAngio WorkStation: XIDF-AWS801v6.00, v6.01, and V6.10 System: INFX-8000V Bi-Plane Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147685
mdprc 148 07 16 000Steris CorpOT1000 Series Orthopedic Surgical Tableshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147015
mdprc 147 07 16 000SIEMENSSyngo.via, picture archiving and communications systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148056
mdprc 146 07 16 000Parks MedicalParker Trach-Vac Endotracheal Tubeshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147877
mdprc 144 07 16 000Hologic Inc. ATEC CANISTERhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147096
mdprc 142 07 16 000Encore Medical, LpLinear Hip Neck Trialshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147751
mdprc 141 07 16 000DeVilbiss Healthcare LLCDeVilbiss Model 7305P-D Powered Suction Unithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147116
mdprc 140 07 16 000Carestream HealthCarestream Touch Primehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148112
mdprc 106 07 16 000Terumo Cardiovascular Systems CorporationHX2 Temperature Management Systems and The Sarns Temperature Control and Monitor unithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147333
mdprc 105 07 16 000Stryker Instruments6.0mm and 5.0mm Round Fluted Burhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147988
mdprc 104 07 16 000Roche Diagnostics CorpCobas Liat Analyzer.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146266
mdprc 103 07 16 000Devicor Medical Products,Inc.Mammotome Revolve Dual Vacuum Assist Biopsy Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147103
mdprc 077 07 16 000Varian Medical SystemsTrueBeam EDGE, Optical Surface Monitoring Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147985
mdprc 076 07 16 000Novarad CorporationNovaPACS http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147900
mdprc 075 07 16 000Arrow International Inc.Femoral Arterial Linehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147757
mdprc 064 07 16 000Synthes Inc. Ti Button Plate , Matrix Neuro Screwdriver Blade and Low Profile Neuro Screwdriver Bladehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147490
mdprc 063 07 16 000Toshiba American Medical Systems Inc. Vantage Titan 3T MRI Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147627
mdprc 061 07 16 000Sorin GroupAORTIC ARCH CANNULAhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147758
mdprc 060 07 16 000Philips HealthcareBrilliance CT Big Bore Oncology & Brilliance CT Big Bore Radiologyhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124851
mdprc 059 07 16 000Medtronic Navigation Inc.Medtronic Navigation O-arm 02http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147271
mdprc 058 07 16 000Medtronic Navigation Inc. Medtronic 0-arm Imaging mobile x-ray system.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146523
mdprc 057 07 16 000Lifeline First Aid LLCFirst Aid Kitshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147244
mdprc 056 07 16 000Hardy DiagnosticsQuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPROhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147263
mdprc 055 07 16 000ExactechNovation Press-Fit Splined RDDhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147140
mdprc 054 07 16 000Custom Ultrasonics, IncThe System 83 Plus, Endoscope Washer/Disinfectorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147130
mdprc 053 07 16 000Arrow International Inc. ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147271
mdprc 036 07 16 000Siemens Medical SolutionsSyngo.plazahttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147343
mdprc 035 07 16 000Physio Control IncLIFEPAK CR Plus and LIFEPAK EXPRESS Automatic External Defibrillatorshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146712
mdprc 034 07 16 000PENTAX Europe GmbHPENTAX—Reusable Water Bottle Assemblies Used with Video Processors, Light Sources, and Endoscopes with Air/Water Channelshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=145337
mdprc 033 07 16 000Medtest Holdings, IncLiquid Stable 2Part Homocysteine Reagenthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146910
mdprc 032 07 16 000Hospira IncLIifeShield CLAVEhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122209
mdprc 031 07 16 000Dynarex Corporationdynarex Specimen Containershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144534
mdprc 030 07 16 000CMP Industries, LlcIMPAK Liquid Acrylic Resinhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146129
mdprc 029 07 16 000CareFusion..Model 8015 Alaris Infusion System PC Units.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146476
mdprc 028 07 16 000Alcon Grieshaber AG.phacofragmentation system, CENTURION Vision Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147055
mdprc 018 07 16 000Nephron CorpNephron Sodium Chloride Solutionhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144035
mdprc 017 07 16 000Implant Direct LLCInterActive Implant OpenTray Transfer Narrowhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146782
mdprc 016 07 16 000EV3 IncEV3 EverFiex Selfexpanding Peripheral Stent Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=147048
mdprc 015 07 16 000Circulatory Technology IncBBB38http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144568
mdprc 014 07 16 000Ceg Enterprises LlcGerm Terminator Toothbrush Steam Sterilizationhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=145923
mdprc 095 06 16 000SIEMENSBiograph mCT Positron Emission Tomography and Computed Tomography Systems. .http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146913
mdprc 094 06 16 000Physio-Control Inc.LIFEPAK15 monitor/defibrillatorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144259
mdprc 090 06 16 000Nico CorpMyriad Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146888
mdprc 087 06 16 000Natus Medical Inc.Natus neoBLUE Phototherapy systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143307
mdprc 080 06 16 000Fresenius Medical Care.Crit Line in a Clip (CLiC).http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146919
mdprc 079 06 16 000Excelsior Medical CorpExcelsior Disposable Syringe Heparin Lock Flushhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146056
mdprc 078 06 16 000Ethicon Endo Surgery Inc. EVARREST Fibrin Sealant Patchhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=145857
mdprc 077 06 16 000Cell Marque CorporationSIOOA I (EP I84) Rabbit Monoclonal Antibodyhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146611
mdprc 076 06 16 000CarboFix Orthopedics, LtdPiccolo Composite Tibia and Femoral Nailing Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146900
mdprc 075 06 16 000Arthrex Inc.BioSync Anatomic Cotton Wedgehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146246
mdprc 058 06 16 000Teleflex MedicalSterile Sheridan/HVT Cuffed, Murphy Eye, Tracheal Tubehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146015
mdprc 057 06 16 000Sysmex Corporation Sysmex XN10 and XN20 Hematology Analyzershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132191
mdprc 056 06 16 000Synthes LCP Dia-Meta Volar Distal Radius Plate 15 H Shaft/LT-Sterilehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146232
mdprc 055 06 16 000Synthes Inc.Norian Drillable Inject Bone Void Fillerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146596
mdprc 054 06 16 000Materialise USA LLCSignature Personalized Patient Care System .http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146807
mdprc 053 06 16 000Becton Dickinson & Co. (BD)Henry Schein Single Use Syringe Luer-Lock, 10 mLhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=145062
mdprc 044 06 16 000Beckman Coulter IncLactate OSR6x93, acid OSR6x98, Cholesterol OSR6x16, Triglyceride OSR6x118 and Lipase OSR6x30 Reagentshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=145427
mdprc 043 06 16 000DePuySynthes1.5 mm RAPIDSORB Rapid Resorbable Orbital Floor Plates with Bending Templateshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146069
mdprc 042 06 16 000Integrated Science Systems IncSure Vue Color Staph 150T, Sure Vue Color Staph 300T, Sure Vue SELECT Staph, biokit SELECT Staph 75Thttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146458
mdprc 041 06 16 000Medical Components, IncTearaway Introducerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146602
mdprc 040 06 16 000Sedecal S.ASedecal SA Mobile Diagnost w DR x-ray systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146293
mdprc 039 06 16 000StrykerStryker FlowPort II Adapterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146181
mdprc 028 06 16 000Windstone Medical Packaging, Inc..Multiple surgical pack..http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144842
mdprc 027 06 16 000Ventlab CorpSTAT-Check Resuscitation Baghttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144926
mdprc 026 06 16 000Natus Medical IncReplacement HEPA filterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=145885
mdprc 025 06 16 000ExactechFemoral Stem and Acetabular Cuphttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146149
mdprc 024 06 16 000Integra YorkMiltex Premium Grade Self-Lock Chisel Blade Handlehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146227
mdprc 010 06 16 000SterilmedReprocessed Microline Scissor Tipshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=145714
mdprc 009 06 16 000Skytron LLCSkytron EZ Slide Operating Tablehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146394
mdprc 008 06 16 000Skytron LLCErgon III Series Articulating Equipment Boom Flatscreen Monitor Bracketshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144784
mdprc 007 06 16 000OlympusModel TJF-160F/VF Duodenoscopeshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144647
mdprc 006 06 16 000MicroAire Surgical InstrumentsPneumatic Impactorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144676
mdprc 005 06 16 000Medscience IncAllergiEnd ST9 Multiple Skin Test Applicator (Item 1000) and AllergiEnd ST9 Multiple Well Test Trahttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144685
mdprc 004 06 16 000Integra LifeSciences Ltd Miltex Premium Grade SelfLocking Chisel Blade Handlehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146227
mdprc 003 06 16 000Baxter Healthcare.COSEAL Surgical Sealant Kitshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146452
mdprc 167 05 16 000American Surgical CompanyAmerican Surgical Various deviceshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=145262
mdprc 158 05 16 000StrykerReprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Cathetershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=145823
mdprc 157 05 16 000Valeant Pharmaceuticals North America LLCOrapharma (Onpharma) Onset Mixing Pen Rx onlyhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144726
mdprc 156 05 16 000Biomet IncPerFuse Decompression Instrumenthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146013
mdprc 155 05 16 000Diamedix CorporationDiamedix Is-CMV IgG Test Kit.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=145394
mdprc 113 05 16 000Zimmer incVarious Sterile-Packaged Hip and Trauma Implant Screwshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=145990
mdprc 112 05 16 000Monteris Medical CorpNeuroBiate System SideFireTM Select 2.2 mm Directional Laser Probehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=145141
mdprc 111 05 16 000Hummingbird MedicalABG-HM-1 Hummi Micro Draw Blood Transfer Deviceshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140711
mdprc 110 05 16 000B Braun Surgical SA90° Huber Needle and Wing Contained in WHIN Infusion Setshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146593
mdprc 109 05 16 000Anspach Cos OCM Cutting Burrs (Cutters)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144999
mdprc 108 05 16 000Neusoft Medical System CoNeuViz 64 Multi-Slice CT Scanner Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=145070
mdprc 107 05 16 000Medtronic Advanced Energy, LLCVisualase Cooled Laser Applicator System (VCLAS)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=146274
mdprc 106 05 16 000Lumenis IncLumenis M22 Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144941
mdprc 105 05 16 000Diamedix CorporationDiamedix Is-Mumps IgG Test Kithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144776
mdprc 079 05 16 000Stryker Sustainability SolutionsMallinckrodt Evac Tracheal Tubeshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=145078
mdprc 078 05 16 000Siemens Healthcare Diagnostics GmbHDimension clinical chemistry system, Sirolimus (SIRO) Flex reagent cartridgehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144211
mdprc 077 05 16 000Covidien LLCCovidien Kangaroo Connect Enteral Feeding Pumphttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144698
mdprc 076 05 16 000Baxter Healthcare CorpGEM Microvascular Anastomotic FlowCOUPLER Deviceshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=145391
mdprc 075 05 16 000AscomAscom Mobile Monitoring Gatewayhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144525
mdprc 062 05 16 000RESEARCH INSTRUMENTS LTDIntegra 3http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144524
mdprc 061 05 16 000Siemens Medical SolutionsSyngo Dynamics; Kinetdx Picture Archiving and Communications Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=145387
mdprc 060 05 16 000Novarad CorporationNovaPAC Diagnostic Viewerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=145814
mdprc 059 05 16 000Ferno-Washington Inc.Poly-bags containing splint strap labeled with "Pediatric" stickerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144677
mdprc 058 05 16 000Atlas SpineAtlas Spine Torque Limiting Handle 6N-mhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144672
mdprc 040 05 16 000SIEMENSMAGNETOM Aera/Skyra Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=145542
mdprc 039 05 16 000FUJIFILM Medical SystemsPower Supply Used with Smart CR Digital X-Ray Cassette Readershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144696
mdprc 037 05 16 000bioMerieux IncVITEK 2 Gram Positive Susceptibility Test Cardshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144536
mdprc 036 05 16 000Alcon Research, Ltd.INFINITI Ultrasound Packhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144937
mdprc 035 05 16 000Synthes GmbHPeriprosthetic Locking Screw Self-tapping 12 mmhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144953
mdprc 034 05 16 000SIEMENSACUSON X700 Ultrasound System http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=145322
mdprc 033 05 16 000Shimadzu Medical Systems.X-Ray Diagnostic Table, Model No. YSF-300http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144860
mdprc 032 05 16 000Philips HealthcareNeuViz 16 Multi-Slice CT Scanner Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144838
mdprc 031 05 16 000Mindray DS USAPanorama Patient Monitoring Network.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144763
mdprc 030 05 16 000LED Technologies, LLCreVive Light Therapy Pain Relief Devicehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144963
mdprc 029 05 16 000JAS Diagnostics Inc.D3 Hematology AnalyzerD3 Reagent Packhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144664
mdprc 025 05 16 000Intuitive Surgical IncEndoWrist Stapler 45 and Stapler 30 instruments used on the da Vinci Xi systems (IS4000)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144835
mdprc 024 05 16 000Hologic IncCF InPlex ASR Cardhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144865
mdprc 023 05 16 000Hardy DiagnosticsGBS Detecthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144758
mdprc 022 05 16 000Becton Dickinson & Co. (BD)BD Trucount Absolute Counting Tubeshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144863
mdprc 138 04 16 000WFR-Aquaplast/Q-Fix SystemsClearVue Prone Breast Treatment Tablehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144438
mdprc 135 04 16 000StrykerSpirit One A-C Powered Hospital Bedhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138676
mdprc 134 04 16 000SIEMENSSiemens SOMATOM Definitionhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144615
mdprc 133 04 16 000Siemens Healthcare Diagnostics ADVIA 560 Hematology Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144542
mdprc 132 04 16 000Philips HealthcareeCareCoordinatorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144720
mdprc 131 04 16 000Mevion Medical Systems, Inc.MEVION S250 for Proton Radiation Therapyhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144555
mdprc 130 04 16 000Hansen Medical, Inc.Magellan Robotic Catheter Accessory Kitshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144725
mdprc 129 04 16 000Boston ScientificUltraflex Tracheobronchial Distal Release Stent Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144674
mdprc 128 04 16 000Becton Dickinson & Co. (BD)Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agarhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144969
mdprc 126 04 16 000Baxter HealthcareAMIA Automated Peritoneal Dialysis System.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144203
mdprc 078 04 16 000Merit Medical Systems IncBoston Scientific TSX Transseptal Needlehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144636
mdprc 077 04 16 000AD-TECH Medical Instrument CorporationAd-Tech Electrode Connection System/Cableshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144756
mdprc 075 04 16 000ICU Medical, IncDiana Automated Compounding Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144403
mdprc 074 04 16 000Natus Medical IncMedix NatalCare ST-LX Intensive Care Incubatorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142443
mdprc 073 04 16 000Us EndovascularUSE (Ebony) PTA .014" rapid exchange (RX) Peripheral Dilatation Catheterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143315
mdprc 048 04 16 000SIEMENSPicture Archiving and Communication System , syngo Imaging.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144261
mdprc 047 04 16 000Arthrex IncArthrex Deltoid Ligamenthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144510
mdprc 046 04 16 000AngioDynamics IncNAMIC Convenience Kithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142590
mdprc 045 04 16 000Therakos Inc A Johnson & Johnson CoThe THERAKOS CELLEX Photopheresis Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142725
mdprc 044 04 16 000ScottCare CorpModel TS01 TeleSentry Batterieshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143993
mdprc 043 04 16 000Philips Electronicsevaluemed Infant Heel Warmer and eValueMed Infant Transport Mattresseshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143732
mdprc 042 04 16 000Innovative Ophthalmic Products, IncMolteno3 Glaucoma Implants G-Serieshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144004
mdprc 041 04 16 000Fresenius Medical CareHemoflow F3 Dialyzershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144015
mdprc 040 04 16 000Cardinal HealthGomco Style Circumcision Clamp Trayshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144307
mdprc 039 04 16 000Biomet Inc.Prelude PF Resurfacing Knee System.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144285
mdprc 038 04 16 000Amd RitmedIMCO brand Conforming Stretch Gauze Bandageshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143875
mdprc 037 04 16 000Implant Direct LLCGoDirect Implantshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144215
mdprc 036 04 16 000Medtronic NeuromodulationModel 8781 Ascenda" Intrathecal Catheter kit, Rx Onlyhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144178
mdprc 034 04 16 000SIEMENSSOMATOM Emotion and Sensation Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144267
mdprc 033 04 16 000SIEMENSArtis zee/ zeego system, x-ray, angiographichttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144445
mdprc 032 04 16 000SIEMENSCIOS ALPHA (Image-intensified fluoroscope x-ray system)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144441
mdprc 031 04 16 000SIEMENSArtis One, Interventional, Fluoroscopic, x-ray systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144567
mdprc 030 04 16 000SIEMENSCios Alpha, mobile X-ray systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144566
mdprc 027 04 16 000PMBS, LLCThe S.C.O.R.E.S. Unithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143282
mdprc 026 04 16 000The Anspach Effort, Inc.Irrigation Clip 30http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144160
mdprc 025 04 16 000Neurotherm, Inc.Neurotherm Curved Radiofrequency (RF) cannnula 10 cmhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144148
mdprc 024 04 16 000Cook Inc,Ascend AQ and UltraxxTM Nephrostomy Balloon Sethttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144044
mdprc 023 04 16 000Biomet IncVanguard XP Knee Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144063
mdprc 004 04 16 000Toshiba Medical Systems CorporationDRAD-3000E FPD Wireless Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142948
mdprc 003 04 16 000Sorin GroupHeaterCooler 3Thttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143928
mdprc 002 04 16 000Siemens Medical SolutionsSiemens Syngo Dynamicshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=144270
mdprc 001 04 16 000Arthrex InciBalance TKA Tibial Trayshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143925
mdprc 152 03 16 000Carl Zeiss Meditec IncSurgical microscope and accessories, OPMI Pentero CFDA
mdprc 146 03 16 000Nordisk Rontgen Teknik A/SGE Precision MPi is an all-digital multipurpose tilt-C x-ray systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141343
mdprc 145 03 16 000Cook Inc,Flexor Check-Flo IntroducerFDA
mdprc 140 03 16 000Value Plastics, Inc.Custom FCFFM x/8.2 cm Tubing Extensionhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142593
mdprc 139 03 16 000TEM Innovations GmbHROTROL P Control for ROTEM delta Thromboelastometry Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143943
mdprc 138 03 16 000Pro-Dex IncKLSBP001 Battery Packhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142867
mdprc 137 03 16 000Medtronic Navigation, Inc.The O-arm O2 Imaging Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143801
mdprc 136 03 16 000Collagen Matrix IncNuOss XC Sinushttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143566
mdprc 135 03 16 000Becton Dickinson & Co. (BD)BD Intelliport Medication Management System Sensorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142710
mdprc 134 03 16 000Bard Pcripheral Vascular (BPV)Nordson Medical Stopcocks Used with Denali Inferior Vena Cava Filtershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143978
mdprc 133 03 16 000Zimmer inc.M/L Taper Hip Prosthesishttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143788
mdprc 132 03 16 000StrykerAccuPlace Needle Guideshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143589
mdprc 131 03 16 000Novadaq Technologies Inc.PINPOINT Endoscopic Fluorescence Imaging Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143596
mdprc 130 03 16 000Medical Action Industries IncTegaderm PICC/CVC dressing change convenience kithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143609
mdprc 129 03 16 000Gi SupplyLarge Volume Paracentesis Kithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143218
mdprc 128 03 16 000Bigwall EnterprisesWarm Steam Personal Steam Inhalerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142338
mdprc 127 03 16 000Cooper Surgical, Inc.Milex Arcing Diaphragmhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143902
mdprc 126 03 16 000AesculapColumbus Revision Knee System, EnduRo Knee Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142358
mdprc 125 03 16 000Xeridiem Mediem Medical Devices IncEndoVive 3s Low Profile Balloonhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142778
mdprc 124 03 16 000Teleflex MedicalWECK AutoEndo5 Hem-o-lok 5 mm Automatic Endoscopic Hem-o-lok Appliershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143353
mdprc 123 03 16 000SIEMENSMammomat Inspiration with Tomosynthesis functionalityhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143817
mdprc 122 03 16 000Karman Healthcare Inc. Karma Flexx Wheelchairhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143292
mdprc 121 03 16 000Ivoclar Vivadent AGHelioseal Clear Refillhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143819
mdprc 120 03 16 000Integrated Medical Systems IncOlympus endoscopehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143143
mdprc 119 03 16 000Fresenius Kabi LtdFresenius Naturalyte Liquid Acid Concentratehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143014
mdprc 005 01 16 001Draeger Medical Systems IncEvita V500 Ventilator and Babylog VN500 Ventilatorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143615
mdprc 118 03 16 000Cook Inc,Kopans Breast Lesion Localization Needleshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143030
mdprc 117 03 16 000Biomet Inc.HipLOC CHS Plate/Lag Screw Introducerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143636
mdprc 093 03 16 000Stryker Howmedica Osteonics CorpStryker Vitallium Wire (6 Pack) Non Sterile.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142877
mdprc 092 03 16 000SIEMENSSyngo Plaza Picture archiving and communication systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142876
mdprc 091 03 16 000Hospira Inc.Symbiq Infusion Pump System Pole Clamp Assemblieshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143072
mdprc 090 03 16 000Hill RomBariatric Power Reclinerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143155
mdprc 089 03 16 000EKOS CorpEkoSonic Endovascular Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143565
mdprc 083 03 16 000Centurion Medical ProductsCenturion Convenience Kitshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143304
mdprc 081 03 16 000SorinDual Stage Venous Return Catheter.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143595
mdprc 080 03 16 000Smith & NephewHigh Flow Irrigation Extenderhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142484
mdprc 079 03 16 000OlympusDELTA XRF analyzerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143625
mdprc 078 03 16 000Bio RadEVOLIS Microplate Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142855
mdprc 050 03 16 000Viewray IncorporatedMRIdian ViewRay Radiation Therapy Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143035
mdprc 049 03 16 000Pharmacaribe llcPulmoSalhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142921
mdprc 048 03 16 000OrthofixFirebird Spinal Fixation System Torque Limiting Handlehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142988
mdprc 047 03 16 000Moog Medical Devices Group IncCurlin and Painsmart Ambulatory Volumetric Infusion Pumpshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142508
mdprc 046 03 16 000Zimmer incZimmer IMPLANT,TM, MTXhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142734
mdprc 045 03 16 000Toshiba Medical Systems INFX-8000V Bi-Planehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143016
mdprc 044 03 16 000Salter LabsT-piece Nebulizer with in-line connectorshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143122
mdprc 041 03 16 000Mizuho Mizuho OSI Trios, Table Basehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142535
mdprc 080 02 16 000Siemens Healthcare Diagnostics GmbHMultiple acute care kitshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141547
mdprc 079 02 16 000Trumpf Medical Systems, Inc.Jupiter, Mars, Titan, TruSystem and Saturn operating table systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143071
mdprc 078 02 16 000Spectranetics Corporation2.3mm Turbo-Power OTWhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=143064
mdprc 077 02 16 000Philips Medical SystemsThe Pinnacle3 Radiation Therapy Planning Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142775
mdprc 076 02 16 000Del Medical, Inc.VS300 and VS200 radiographic Cassette Holder or Wall Standhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142237
mdprc 075 02 16 000Bard Pcripheral Vascular (BPV)Bard Distaflo Vascular Bypass Grafthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142774
mdprc 055 02 16 000Radiometer MedicalAQURE System.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142591
mdprc 054 02 16 000Global Healthcare Inc.ET-20 Anesthesia Extension Tubeshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142907
mdprc 036 02 16 000Instrumentation LaboratoryHemosIL Plasminogenhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142610
mdprc 035 02 16 000HORIBA ABX DiagnosticsABX PENTRA http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142858
mdprc 034 02 16 000Baxter HealthcareRAPIDFILL Syringe Strip.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142564
mdprc 033 02 16 000Bard Pcripheral Vascular (BPV)Bard Denali IVC Filterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142563
mdprc 100 01 16 000Siemens Medical SolutionsE.cam Dual Signature; Gamma Camerahttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142872
mdprc 099 01 16 000Rymed Technologies, LLCInVision-Plus, InVision-Plus and InVision-Plus CS Needleless IV Connectorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142692
mdprc 077 01 16 000MAQUET IncServo-I ventilator system CO2 analyzerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132596
mdprc 076 01 16 000Zimmer incPeriarticular Locking Plate System http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142544
mdprc 075 01 16 000Biomet IncBiomet Integral Centralizer Hip Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141358
mdprc 074 01 16 000Beckman Coulter InciChem 10 SG Urine Chemistry Stripshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142510
mdprc 070 01 16 000Thornhill Research IncMOVES Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142381
mdprc 069 01 16 000StrykerReprocessed Stryker Color Cuff and Color Cuff IIhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142400
mdprc 068 01 16 000PerkinelmerWIZARD2 Automatic Gamma Counterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142254
mdprc 067 01 16 000Mercury MedicalNeo-Tee T-Piece Resuscitator and T-Piece Circuithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141479
mdprc 061 01 16 000OrthoPediatrics CorpUniAxial Pedicle Screw & UniAxial Reduction Pedicle Screwhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142594
mdprc 060 01 16 000Nipro Medical CorporationNIPRO SET / SLIMLINE BLOOD TUBING SEThttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142001
mdprc 047 01 16 000Ultradent Products, IncInterGuard 5.5mm Econo Refillhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142285
mdprc 046 01 16 000Steris CorpAMSCO® Warming Cabinethttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142305
mdprc 045 01 16 000Philips Philips Lumify Diagnostic Ultrasoundhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142399
mdprc 044 01 16 000Benlan, Inc.MED-RXhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142354
mdprc 041 01 16 000Vidco, Inc.Remote Patient Monitoring Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142223
mdprc 040 01 16 000Stryker Sustainability SolutionsResterilized Fuhrman Pleural/Pneumopericardial Drainage Setshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142020
mdprc 039 01 16 000Smith & NephewGENESIS II/LEGION Resurfacing Patella with JOURNEY Peghttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142377
mdprc 038 01 16 000CorflexContender Post-op-Knee Brace Litehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142040
mdprc 037 01 16 000CNSystems CNSystems TASK FORCE MONITOR 3040ihttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142016
mdprc 011 01 16 000Biomet 3i IncART 1036 Radiographic Transparencyhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141861
mdprc 010 01 16 000Becton Dickinson & Co. (BD)Vacutainer K2EDTA Plus Plastic Blood Collection Tubeshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142383
mdprc 009 01 16 000Rainbow Specialty & Health ProductsDressit-Xhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142039
mdprc 008 01 16 000Philips HealthcareCardinal Health Tiny Toeshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141972
mdprc 007 01 16 000Merge Healthcare Corp.Merge Hemo and Merge Cardiohttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141901
mdprc 006 01 16 000Hardy DiagnosticsFB Brothhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142209
mdprc 004 01 16 000DePuy International LtdVAPR TRIPOLAR 90" Degree Suction Electrodeshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142122
mdprc 003 01 16 000Biomet IncGreen and Black Mamba Suture Passerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142310
mdprc 002 01 16 000Arthrosurface, Inc.Total Toe Instrument Kithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141991
mdprc 001 01 16 000Airways Development LLCWaterPAP Positive Airway Pressure Devicehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142352
mdprc 113 12 15 000Zimmer incZimmer Oscillating Flathttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142288
mdprc 108 12 15 000SIEMENSSOMATOM Definitionhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142157
mdprc 107 12 15 000Instratek IncorporatedEndoscopic Tarsal Tunnel Decompressionhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142098
mdprc 106 12 15 000DePuy Spine, Inc Aegis Torque Handlehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141825
mdprc 105 12 15 000CareFusion 303, Inc.Alaris EtCO2 Moduleshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141712
mdprc 100 12 15 000Edwards LifesciencesIntravascular (IV) Administration Setshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141985
mdprc 099 12 15 000Myco Medical SuppliesUnolok Blunt Fill Needle 18G x 1.5" Red, Sterile, Single usehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141671
mdprc 098 12 15 000RemelOxoid Gentamicin Antimicrobial Susceptibility Testing Disc (CN10),http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141388
mdprc 097 12 15 000Summit Medical, Inc.AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Packhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140459
mdprc 093 12 15 000Verathon IncGlideScope Video GVL and AVL Laryngoscope Bladeshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141766
mdprc 092 12 15 000Teleflex MedicalHudson RCI Heated Ventilator Circuitshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142044
mdprc 091 12 15 000Stryker CommunicationsStryker Cournand Modified 2PC 19 gauge, 5.4 centimeter guidewire introducer needleshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=142281
mdprc 090 12 15 000Moog Medical Devices Group IncEnteraLite Infinity Enteral Pumps and Administration Setshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141973
mdprc 089 12 15 000K-jump Health Co LtdK-Jump Digital Temple Thermometershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141980
mdprc 088 12 15 000FUJIFILM Medical SystemsDudenoscopehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140362
mdprc 073 12 15 000Philips HealthcareBrilliance CT (computed tomography) scanners, Big Bore configurationhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129680
mdprc 072 12 15 000Philips HealthcareThe eCareManager systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135619
mdprc 071 12 15 000Boston ScientificOne Step Button, Low Profile Initial Placement PEG Kit.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140781
mdprc 070 12 15 000Draeger Medical IncPerseus A500 Anesthesia Workstation, MK06000.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141791
mdprc 069 12 15 000Philips HealthcarePhilips Healthcare Brilliance 64, Ingenuity Core, Ingenuity Core 128 and Ingenuity CT Computed Tomography X-ray systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139378
mdprc 043 12 15 000Intuitive Surgical Inc Telemanipulation Systems, Surgical, Minimally Invasive, daVincihttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117854
mdprc 028 12 15 000WalkMed Infusion, LLCTriton fp Infusion Pump (model 400000)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141640
mdprc 027 12 15 000Merz pharmceuticalsPROLARYN Gel and PROLARYN PLUS Injectable Implantshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141619
mdprc 020 12 15 000DeRoyal Industries Inc.HYDRO-TEMP®http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141078
mdprc 019 12 15 000DeRoyal Industries Inc.Various DeRoyal Surgical Kits.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141577
mdprc 117 11 15 000Alcon Research, LtdAcrySof IQ Toric IOLhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140828
mdprc 114 11 15 000Philips Medical SystemsIngenia, Intera, Achieva and Achieve dStreamhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129687
mdprc 113 11 15 000Leonhard Lang GmbHECG Electrodes 50007http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141578
mdprc 099 11 15 000Teleflex MedicalPI-93 Taut Intraducer Peritoneal Catheters with Martech Hemo Valve Flat Capshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140988
mdprc 098 11 15 000Cyberonics IncCyberonics VNS Therapy AspireSR Generatorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140876
mdprc 097 11 15 000Civco Medical Instruments IncInfiniti Plus kitshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140835
mdprc 096 11 15 000AstoraMiniArc Prohttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141509
mdprc 095 11 15 000AGFA Corp.IMPAX Cardiovascular IMPAX CV12http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140966
mdprc 083 11 15 000Precision Medical.Easy Dial Oxygen Regulatorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141042
mdprc 082 11 15 000MedtronicPerfusion Tubing Packshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141501
mdprc 081 11 15 000Instrumentation Industries IncCuffed Ventilator Tubinghttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140927
mdprc 073 11 15 000Ceterix Orthopedics, Inc.NovoCut Suture Managerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141289
mdprc 061 11 15 000Villa Radiology Systems LLC.Villa Sistemi Rotograph EVO and Owandy Radiology I -MAX Touch 3D X-rayhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139450
mdprc 060 11 15 000Utah Medical Products, IncMyelo-Nate CSF Sampling Kitshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141130
mdprc 059 11 15 000Resource Optimization & Innovation LlcRegard Custom Surgical Pack..http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139676
mdprc 058 11 15 000Miramar Labs, Inc.miraDry Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140877
mdprc 057 11 15 000DeRoyal Industries Inc.DeRoyal Sterile Custom Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solutionhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139865
mdprc 056 11 15 000CareFusion 303, IncSmartSite Extension Sets.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140871
mdprc 055 11 15 000Stryker Spine UniVise Spinous Process Fixation Plate System Inserterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141264
mdprc 054 11 15 000Ivoclar Vivadent Helioseal F Sealant Refill 1 x 1.25 ghttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140485
mdprc 053 11 15 000ELITech Clinical Systems SASEnvoy 500 , Eon 100, Eon 300 and Selectra ProS and ProM systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140619
mdprc 052 11 15 000Bausch & Lomb Inc.BAUSCH + LOMB Biotrue(R) ONEday lenses (nesofilcon A)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140144
mdprc 051 11 15 000Arrow International IncPICC Kits with GLIDETHRU Componentshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141136
mdprc 035 11 15 000MedtronicMedtronic Achieve Cableshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139896
mdprc 034 11 15 000Biomet IncMaxAn 4.0mm and 4.5mm fixed screwshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140568
mdprc 024 11 15 000Synthes IncSynthes Threaded Plate Holder Long for 3.5mm Locking Holdhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140745
mdprc 023 11 15 000Integra LifeSciencesIntegra® Bone Marrow Biopsy Trayshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140452
mdprc 021 11 15 000Baxter HealthcareBaxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid pathhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140768
mdprc 002 11 15 000Perkin Elmer Life Sciences IncPerkin Elmer Specimen Gatehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139579
mdprc 001 11 15 000Encore Medical, LpExprt Precision System: Revision Kneehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140223
mdprc 111 10 15 000Stryker TELETOM Series 4 and 6 Boomshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140448
mdprc 110 10 15 000Materialise N.VThe Signature Personalized Patient Care Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=141084
mdprc 109 10 15 000Biomet IncThinflap System Case and Neuro Combo Set Casehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140801
mdprc 108 10 15 000B Braun Medical IncPerifix Continous Epidural Anesthesia Pain Control Trayshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140317
mdprc 100 10 15 000Synthes Inc5.0mm Unit Stainless Steel Rods for the Synthes Small Stature USShttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139928
mdprc 099 10 15 000Cardinal-HealthAmbitex NMD400 Nitrile Exam Gloveshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140214
mdprc 098 10 15 000Encore Medical, LpAltiVate Humeral Socket Shell Trialhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140188
mdprc 090 10 15 000Synthes IncSynthes Screw Inserterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140322
mdprc 089 10 15 000Synthes Inc2.7 mm/3.5 mm VA-LCP Medial Distal Plateshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140637
mdprc 088 10 15 000DJO LCMonode , Shortwave Accessoryhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140080
mdprc 068 10 15 000Natus Medical IncNicoletOne Software v5.94 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139574
mdprc 067 10 15 000Medtronic IncPipeline and Pipeline Flex Embolization Devices http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140075
mdprc 050 10 15 000Concentric Medical IncDistal Access Cathetershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140343
mdprc 049 10 15 000Viewray IncorporatedMRIdian® ViewRay® Radiation Therapy Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140076
mdprc 048 10 15 000SIEMENSSOMATOM Forcehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139933
mdprc 043 10 15 000Beckman Coulter, Inc..MICroSTREP plus 1 and MICroSTREP plus 2 Panelshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140096
mdprc 042 10 15 000Toshiba Medical Systems CorporationToshiba Celesteion PCA-9000A/2 PET/CT Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138996
mdprc 041 10 15 000Resource Optimization & Innovation LlcMultiple surgical kitshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139308
mdprc 040 10 15 000Zimmer incZimmer Universal Locking Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139904
mdprc 039 10 15 000Ortho SolutionsUltOS Locking Screwshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139303
mdprc 037 10 15 000Integra LifeSciencesUniversal Compact Head Ring Adapter Plate (UCHRAP)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139703
mdprc 036 10 15 000Synthes IncPeriarticular Insertion Handle and Periarticular Aiming Arm for 4.5mm LCP Proximal Tibia Plateshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140316
mdprc 025 10 15 000Ferno-Washington IncFerno iNX Wheeled Stretcherhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139518
mdprc 024 10 15 000Biosense Webster Inc SOUNDSTAR eco 8F and 10Fhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140078
mdprc 016 10 15 000Lifeline Systems, IncorporatedPhilips GoSafe Mobile Help Button; 7000MHBhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139235
mdprc 007 10 15 000Arrow International IncKits Containing Medtronic Covidien 0.9% Sodium Chloride Flush Syringeshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139778
mdprc 136 09 15 000STERILMED, INCReprocessed Zimmer Tourniquet Cuffshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139625
mdprc 126 09 15 000Synthes IncCranial Flap Tube Clamp and Crimping Devicehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139935
mdprc 111 09 15 000Resource Optimization & Innovation LlcRegard ™http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139600
mdprc 097 09 15 000Terumo Cardiovascular Systems CorporationTerumo Custom Cardiovascular Procedure Kit X-Coated.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139621
mdprc 096 09 15 000Ecolab IncORS Fluid Warming and Slush Drapeshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139446
mdprc 094 09 15 000SynCardia Systems IncTemporary Total Artificial Heart (TAH-t) with Freedom Driver Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139311
mdprc 093 09 15 000Intuitive Surgical IncFluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=140020
mdprc 092 09 15 000Edwards LifesciencesPressure Monitoring Kits and Setshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139472
mdprc 091 09 15 000Lumenis IncLumenis—VersaCut+ Tissue Morcellator Handpieceshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139255
mdprc 083 09 15 000Nico CorpNICO Myriad Consolehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139582
mdprc 082 09 15 000Applied Medical ResourcesVoyant Open Fusion Devicehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139445
mdprc 081 09 15 000Med Tec IncCIVCO Shoulder Retractorshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139409
mdprc 072 09 15 000Revmedx IncXGAUZE Trauma Dressinghttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139586
mdprc 071 09 15 000Biomet 3i IncUCLA Abutment Hexed Castable Cylinder 3.4mmhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139565
mdprc 070 09 15 000Intuitive Surgical IncDa Vinci Si Single-Site Gripping Instrumentshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139635
mdprc 069 09 15 000Terumo Cardiovascular Systems CorporationCDI 500 Blood Parameter Monitoring Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139412
mdprc 068 09 15 000Biomet Inc4 0 MM X 14 MM Variable Screw CTek Maxan Anterior Cervical Plate Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139414
mdprc 061 09 15 000Wright Medical Technology, Inc.CrossCHECK™http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139287
mdprc 060 09 15 000SIEMENSSyngo.plaza;picture archiving and communications systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139480
mdprc 059 09 15 000Roche Diagnostics Corpcobas® Liat Analyzerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139100
mdprc 058 09 15 000Panoramic Rental Corp.PC-1000 Panoramic X-Ray Machineshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138586
mdprc 057 09 15 000Mindray DS USA, Inc.DPM 7 Monitorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139403
mdprc 056 09 15 000MedtronicMEDTRONIC PERFUSION TUBING PACKS and MEDIVATORS HEMOCORhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139597
mdprc 055 09 15 000LimacorporateTrial Adaptor Headhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139473
mdprc 054 09 15 000Covidien LLCCovidien Monoject 0.9% Saline Flush Syringes and Prefill Double Poucheshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139418
mdprc 053 09 15 000C.R. Bard, Inc.Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tiphttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139591
mdprc 032 09 15 000Trilliant Surgical Ltd7, 9, & 11Hole VL Gridlock Fibula Plating Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139466
mdprc 030 09 15 000Arrow International IncPICC Kits and VPS Access Kits with Touhy Borst Componenthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139228
mdprc 029 09 15 000Pointe Scientific IncG6PD Screening Controlshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139536
mdprc 028 09 15 000Biomet IncVision RingLoc Acetabular Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139224
mdprc 027 09 15 000Trilliant Surgical LtdTiger Cannulated Tray Lidhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139142
mdprc 026 09 15 000Tornier IncSalto Talaris Tibial Guidehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139327
mdprc 025 09 15 000Synthes IncSynthes Application Instrument for Sternal ZIPFIXhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139179
mdprc 024 09 15 000Sunrise MedicalZippie IRIS and Quickie IRIS Wheelchairshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139171
mdprc 023 09 15 000Stryker Reprocessed Ethicon ExcelTrocar Sleevehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139129
mdprc 022 09 15 000Nidek Co. Ltd.OPD-Scan III Refractive Power/Corneal Analyzer Opthalmichttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138756
mdprc 021 09 15 000Hardy DiagnosticsHardyCHROM MRSAhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139127
mdprc 010 06 14 001Physio Control IncLIFEPAK 1000 DefibrillatorsSwissmedic
mdprc 211 08 15 000RaySearch Laboratories RayStation 4.7http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137704
mdprc 208 08 15 000The Anspach Effort, Inc.Synthes Battery Power Line II Oscillatorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138616
mdprc 207 08 15 000Symmetry SurgicalDisposable Towel Clampshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137258
mdprc 206 08 15 000Sedecal S.ARadPro 40kW Digital X-Ray Panel and Mobile/Portable Diagnostic X-Rayhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138818
mdprc 205 08 15 000Medtronic Navigation IncMedtronic Passive Biopsy Needle Kithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138971
mdprc 204 08 15 000GE HealthcareGE Optional Laser Centering Device X-ray generator.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131702
mdprc 141 06 15 001Fresenius Medical CareFresenius NaturaLyte Bicarbonate Concentrate Bottleshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=136307
mdprc 203 08 15 000CareFusion 303, IncAlaris Syringe Pump, Model No. 8110http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138585
mdprc 202 08 15 000C.R. Bard, Inc.Magic3 Hydrophiliccoated Female Intermittent Catheterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138833
mdprc 201 08 15 000B BraunCelsite Implantable Access Port Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138664
mdprc 200 08 15 000American Science & Engineering, Inc.Gemini Cabinet Xray systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138765
mdprc 199 08 15 000Advanced Sterilization ProductsWall Chart for STERRAD 100NX Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138474
mdprc 198 08 15 000The Anspach Effort, Inc.Synthes Battery Power Line II Oscillatorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138616
mdprc 197 08 15 000Trilliant Surgical LtdConcave Reamer Head, Cannulated Drill Bithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139145
mdprc 196 08 15 000Synthes IncTibial Nail Wrap Holds 11 Nails and Synthes Intramedullary Nail Wrap Holds 10 Nailshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138815
mdprc 195 08 15 000SIEMENSSiemens Symbia T Series, Siemens Intevo Series system, Siemens Symbia S Series systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139260
mdprc 194 08 15 000Otto Bock Healthcare Products GmbHGenium X3http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139437
mdprc 193 08 15 000Elite Biomedical SolutionsAlaris Medley Large Volume Pump Frame Membraneshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138352
mdprc 192 08 15 000Covidien LLCCovidien Argyle Infant Heel Warmershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=139096
mdprc 189 08 15 000Zimmer incDual Port/Single Bladder Disposable Tourniquet Cuffhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138728
mdprc 188 08 15 000Roche Diagnostics CorpS2 Fluid Pack as a part of the cobas b221 Roche OMNI S systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138377
mdprc 187 08 15 000Invacare CorporationInvacare Pronto Air Personal Transporterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138406
mdprc 186 08 15 000Atrium Medical CorporationAtrium 36Fr Right Angled Firm PVC Thoracic Catheterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138023
mdprc 153 08 15 000Synthes IncTitanium Matrix Pre-bent Maxillary Plateshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138328
mdprc 152 08 15 000Skeletal Kinetics, LlcInjectionPlasty 1.0http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137879
mdprc 151 08 15 000Otto Bock Healthcare Products GmbHOttobock Pheon 3R62 Knee Jointhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138816
mdprc 150 08 15 000McKesson Technologies, IncParagon Laboratory Managementhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138221
mdprc 149 08 15 000Encore Medical, LpFemoral Cut Blockhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138622
mdprc 122 08 15 000Myoscience Inciovera 155 Smart Tiphttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138539
mdprc 121 08 15 000EKOS CorpEKOS EkoSonic Endovascular Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138434
mdprc 120 08 15 000Cochlear AGCochlear Nucleus Sterile Silicone Templatehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138017
mdprc 119 08 15 000Abbott LaboratoriesARCHITECT c8000 Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137918
mdprc 097 05 15 001GE HealthcareCT LightSpeed 16http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=136320
mdprc 109 08 15 000Stryker CommunicationsStryker SelectCore Variable Throw Biopsy Device, 14G, 10CMhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138120
mdprc 108 08 15 000Allergan services international LimitedNatrelle 133 Series Tissue Expandershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137972
mdprc 011 08 15 000Synthes IncTFNA Helical-Blade Impactorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137950
mdprc 010 08 15 000Stryker InstrumentsNeptune 2 Waste Management Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137933
mdprc 009 08 15 000Cooper Surgical, Inc.Milex Vaginal-Hymenal Silicone Dilatorshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138256
mdprc 008 08 15 000AlereAlere i flu, Alere i, Alere Influenza A & Bhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138289
mdprc 007 08 15 000Zimmer incZNN Antegrade Femoral Nail (ZNN AF)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138114
mdprc 006 08 15 000StrykerStryker Woundcare Tubing Replacement Setshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137181
mdprc 005 08 15 000OMNIlife scienceApex ARC Hip Stemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137697
mdprc 004 08 15 000Integra LifeSciencesIntegra Long Epidural Steroid Injection Needle (Tuohy Needle).http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=136261
mdprc 003 08 15 000ExactechExactech Ambassador Cervical Plate System and Exactech Single Barrel Drill Guideshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138003
mdprc 002 08 15 000ExactechExactech Spine, Large Set Screwhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138110
mdprc 001 08 15 000Biomet IncA.L.P.S., Distal Tibia Plating Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138179
mdprc 058 07 15 000Synthes IncTITANIUM END CAP WITH T40 STARDRIVE RECESShttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137807
mdprc 057 07 15 000Maquet CardiovascularSuspension Arms Used With PowerLED, Volista, and X-TEN Surgical Light Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137391
mdprc 056 07 15 000Biomet IncA.L.P.S. Foot Locking Calcaneus Platehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138025
mdprc 055 07 15 000Allergan IncNatrelle Re-sterilizable Breast Implant Sizerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137741
mdprc 035 07 15 000SIEMENSACUSON SC2000 Ultrasound Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137900
mdprc 034 07 15 000SIEMENSSYNGO IMAGINGhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138013
mdprc 091 09 14 001Justright Surgical, LLCJustRight 5mm Reloadhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129735
mdprc 029 07 15 000SIEMENSSOMATOM Emotion 6 & SOMATOM Emotion 16http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138061
mdprc 028 07 15 000Sechrist Industries IncSechrist Low Profile Wheeled Stretcherhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137869
mdprc 027 07 15 000Ortho-Clinical DiagnosticsVITROS 5,1 FS Chemistry System, VITROS 5,1 Refurbished, VITROS 4600 and 5600 Chemistry System..http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119029
mdprc 026 07 15 000New Star Lasers, Inc.StoneLight 30 Laser System (NS3000)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137356
mdprc 025 07 15 000LifeHealth, LLCIRMA TRUPOINThttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137245
mdprc 024 07 15 000Biomet IncGentle Threads Interference Screw 9x35mm Full Threadhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138106
mdprc 023 07 15 000Atrium Medical CorporationA.Oasis Drain, Dry Single W/AChttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135861
mdprc 022 07 15 000RTI Surgical, IncBullet-Tip PEEKVBR/IBF Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137744
mdprc 021 07 15 000Pega MedicalSCFE Drivers of the FreeGliding SCFE Screw Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138189
mdprc 012 07 15 000Teleflex MedicalHudson RCI LIFESAVER Neonate Manual Resuscitatorshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137056
mdprc 011 07 15 000Cook MedicalLapSac Surgical Tissue Poucheshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137267
mdprc 010 07 15 000StrykerSERFAS 90 degree Energy Probehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137610
mdprc 149 06 15 000Terumo Cardiovascular SystemsCustom Cardiovascular Procedure Kitshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=136456
mdprc 148 06 15 000X Spine Systems IncFortex Pedicle Screw System Continuous Radius Rod 5.5 50mmhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137421
mdprc 147 06 15 000Merit Medical Systems IncPrelude Sheath Introducershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=138060
mdprc 140 06 15 000Cooper Surgical, Inc.McKesson Medi-Pak Vaginal Speculumhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137298
mdprc 118 06 15 000Biomet IncConstrux Alum Ankle Clamphttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137058
mdprc 117 06 15 000MedtronicMedtronic Passive Planar Blunt Probehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137215
mdprc 116 06 15 000Mortara Instrument, Inc.ELI 380 Electrocardiographhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137689
mdprc 115 06 15 000Smith & Nephew OrthopaedicREFLECTION 3 Acetabular System-Constrained Acetabular Linerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137316
mdprc 114 06 15 000OrthofixFirebird Spinal Fixation Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137255
mdprc 113 06 15 000Teleflex MedicalTHE T.A.L.O.N. INTRAOSSOUS INFUSION SYSTEMhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137034
mdprc 112 06 15 000Stryker InstrumentsNavigation Systems-II Carts and Articulated Arm Camerashttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137176
mdprc 111 06 15 000Siemens Healthcare Diagnostics GmbHEasyLink(TM) Informatics System included with the Dimension Vista Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110905
mdprc 110 06 15 000Neusoft Medical System CoNeusoft NeuViz 64 Multi-slicehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137271
mdprc 065 06 15 001MRP, LLC dba AMUSA0.9 Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterilehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135755
mdprc 109 06 15 000DePuySynthesPull Reduction Devices for 4.3 mm Percutaneous Drill Guideshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137453
mdprc 108 06 15 000CareFusion Alaris PC unit model 8015http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=136048
mdprc 092 06 15 000Zimmer incZimmer M/L Taper Hip Prosthesis with Kinectiv Technologyhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137182
mdprc 091 06 15 000Vilex In Tennessee IncVilex, Inc., FUZE 10.0 mm x 150 mmhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137355
mdprc 090 06 15 000Cooper Surgical, Inc.Ally Uterine Positioning System (Ally UPS)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137273
mdprc 089 06 15 000Alcon Research, LtdThe Alcon Custom Pakhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=136291
mdprc 088 06 15 000Advanced Sterilization ProductsTyvek Pouch/Roll with STERRAD Chemical Indicatorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132564
mdprc 067 06 15 000Advanced Back Technologies, Inc.Extentrac Elitehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135953
mdprc 066 06 15 000Roscoe Medical IncNEBROS, Roscoe Mini Neb Compressorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=136146
mdprc 063 06 15 000Synthes, Inc.Cannulated Drill Bitshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137214
mdprc 041 06 15 000Zimmer incTibial Alignment Guidehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137123
mdprc 040 06 15 000SIEMENSSyngo.via and Syngo.xhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137299
mdprc 039 06 15 000Smiths Medical, IncBCI Advisor Vital Signs Monitorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134714
mdprc 038 06 15 000Philips Medical SystemsIngenuity TF PET/MRhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=136871
mdprc 037 06 15 000Philips Medical SystemsBrilliance iCThttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=136899
mdprc 036 06 15 000Bayer Healthcare LLC…MEDRAD Stellant CT Injector System with Certegrahttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137254
mdprc 029 06 15 000Coreva Health Science LLCActCel Topical Hemostatic Dressinghttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137216
mdprc 006 06 15 000Stryker InstrumentsEliteCore FullCore Biopsy deviceshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=136466
mdprc 005 06 15 000DePuy Spine, IncEXPEDIUM Spine System/Synapse Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135980
mdprc 004 06 15 000Alere International LimitedAlere i Influenza A & Bhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135960
mdprc 132 05 15 000Ethicon Endo Surgery IncENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip,http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=136653
mdprc 131 05 15 000Richard-Allan ScientificLerner Laboratories Mucolexx, Mucolytic Agent 1http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=136396
mdprc 130 05 15 000DeRoyal Industries IncDeRoyal Medium Specimen Retrieval Bag,http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=136431
mdprc 129 05 15 000CooperSurgical IncModel CTI-1015P 15 mm Suture Guide Used with Carter Thomason II Port Closure Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134970
mdprc 128 05 15 000Philips HealthcarePhilips Healthcare DigitalDiagnost and DuraDiagnost Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135515
mdprc 127 05 15 000Philips HealthcareEPIQ 7 Ultrasound System, WITHOUT the Pediatric Cardiology optionhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=136136
mdprc 126 05 15 000Stryker OrthopaedicsTriathlon Femoral, Scorpio Femoral, Restoration Wedge Augmentshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135835
mdprc 125 05 15 000Siemens Medical SolutionsSIEMENS Axiom Luminos dRF Maxhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137251
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137253
mdprc 124 05 15 000United Surgical Associates.iGO, Elastic Ankle Support.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137082
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137085
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137088
mdprc 123 05 15 000Siemens Medical SolutionsSOMATOM Perspective, SOMATOM Emotion 16, SOMATOM Emotion 6http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=136101
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137249
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137248
mdprc 102 05 15 000Stryker Howmedica Osteonics CorpKinemax Stem Extenders, 80 mmhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134666
mdprc 101 05 15 000HeartWare IncHeartWare Ventricular Assist System (HVAD)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=136083
mdprc 100 05 15 000Handicare GmbHReTurn belthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135822
mdprc 099 05 15 000FUJIFILM Medical SystemsFujiMedical Synapse® Cardiovascular I ProSolv® CardioVascularhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135415
mdprc 098 05 15 000Wright Medical Technology, Inc.PHALINX (TM) HAMMER TOE HANDLEhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=136234
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=136235
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=136231
mdprc 096 05 15 000Baxter HealthcareABACUS Total Parenteral Nutrition Calculation Software.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135694
mdprc 088 05 15 000Philips HealthcareADAC Vertex and Solus Gamma Camera Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=136423
mdprc 087 05 15 000Philips Medical SystemsADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60 & ADAC CARDIO C60http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=136200
mdprc 050 05 15 000BD Diagnostic Systemsliquid-based thin layer cell preparation process, PrepStain Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109899
mdprc 049 05 15 000Zimmer incNexGen Augmenthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135840
mdprc 048 05 15 000Teleflex MedicalHudson RCI ConchaTherm Neptune Heated Humidifiershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135428
mdprc 047 05 15 000Steris CorpAMSCO C and AMSCO 400 Steam Sterilizershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135639
mdprc 046 05 15 000GE HealthcareGE Discovery MR950http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134519
mdprc 045 05 15 000CareFusion CorpVital Signs z Styletshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134609
mdprc 044 05 15 000Bard Access SystemsPowerLoc MAX Safety Winged Infusion Sethttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135029
mdprc 043 05 15 000B Braun Medical Inc.CONTIPLEX Continuous Peripheral Nerve Block Trayhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135327
mdprc 038 05 15 000Spacelabs Healthcare IncUltraview SL Command Moduleshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=136025
mdprc 037 05 15 000Pega MedicalFassier-Duval IM Telescopic Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135963
mdprc 036 05 15 000Nihon Kohden Corp.Remote Network Stationhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135847
mdprc 035 05 15 000Integra LifeSciencesIntegra Long Epidural Steroid Injection Needle (Tuohy Needle)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135366
mdprc 034 05 15 000Fresenius Kabi LtdFresenius Various 2008 Hemodialysis Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135406
mdprc 033 05 15 000Alphatec Spine Inc4.0mm Variable Angle, SelfDrilling Hexalobe Screw, 14mmhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135722
mdprc 032 05 15 000GE HealthcareBrivo XR285amx, Optima XR200amx, and Optima XR220amx X-Ray Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135536
mdprc 031 05 15 000GA Industries Logicon Caries Detectorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135053
mdprc 030 05 15 000Biocare Medical LlcCD99 Antibody Reagentshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134965
mdprc 029 05 15 000Beckman CoulterMicroScan Pos Combo Panel Type 33 (PC33)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135479
mdprc 001 05 15 000PhotoMedexIamin Moist Dressing and the Iamin Hydrating Gelhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135054
mdprc 144 04 15 000OriGen BiomedicalReinforced Dual Lumen ECMO Cathetershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135794
mdprc 143 04 15 000Lumenis IncLight Sheer Desire Diode Laser System with XC Handpiece Accessory optionshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135279
mdprc 142 04 15 000CSA MedicalModel CC3-01 truFreeze Consoleshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135174
mdprc 141 04 15 000Siemens Healthcare Diagnostics MicroScan Neg Breakpoint Combo 34 panelhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135379
mdprc 124 04 15 000Specialty AppliancesHerbst Universal Nuthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135031
mdprc 123 04 15 000X Spine Systems IncXpress System Pedicle Screw Assemblyhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134646
mdprc 112 04 15 000Thermedx LLCFluid Management System P4000http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132087
mdprc 111 04 15 000Del Mar Reynolds Medical, Ltd. Spacelabs Pediatric Flow Sensor Kit for Blease 700/900 Series Ventilatorshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134610
mdprc 110 04 15 000Catheter Research, IncHSG Trays/HS 5F Catheter Combo; HSG Procedure Tray Shapeablehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135723
mdprc 096 04 15 000Vitrolife, Inc.SpermMarhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132286
mdprc 082 04 15 001Bard Pcripheral Vascular (BPV)Monopty Disposable Biopsy Instrumenthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134572
mdprc 083 04 15 000Hardy DiagnosticsHardyCHROM SS Agarhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134635
mdprc 077 04 15 000Baylis Medical CorpProTrack Microcatheterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135430
mdprc 062 04 15 000Teleflex MedicalVasoNova Vascular Positioning System (VPS ) G4 Console Cataloghttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=135563
mdprc 061 04 15 000Lusys Laboratories, Inc.Multiple Ebola test kitshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134408
mdprc 050 04 15 000Teleflex MedicalPluer-evac Sahara Chest Drainage Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134560
mdprc 049 04 15 000Siemens Healthcare DiagnosticsADVIA Chemistry XPT Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134088
mdprc 048 04 15 000Siemens Healthcare DiagnosticsQuikLYTE(R) Dilution Checkhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134171
mdprc 047 04 15 000Cooper Surgical, Inc.TransWarmer Infant Transport Mattresshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133340
mdprc 046 04 15 000Civco Medical Instruments IncCIVCO Surgi-Tip Transducer Coverhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134563
mdprc 045 04 15 000Bacterin International, IncInstrument Kit for use with OsteoSponge SC graftshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134592
mdprc 029 04 15 000TEM Systems IncROTROL Phttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134494
mdprc 028 04 15 000Biomet IncZiploop Button & ToggleLochttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134383
mdprc 027 04 15 000C.R. Bard, IncUrinary Drainage Bags.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134365
mdprc 026 04 15 000Edwards Lifesciences Fem-Flex II Femoral Arterial Cannulahttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134907
mdprc 025 04 15 000GE HealthcareAespire 7900, Aespire Viewhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134476
mdprc 024 04 15 000Nidek Co. Ltd.YC1800 OPHTHALMIC YAG LASER SYSTEMhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134065
mdprc 023 04 15 000QUEST Medical Inc.LIS27T Lacrimal Intubation Sethttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134177
mdprc 013 04 15 000DePuy Orthopaedics, IncRECLAIM Assembled Implant Inserter Adaptorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134495
mdprc 145 03 15 000Zimmer incNexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTALhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134147
mdprc 144 03 15 000TITAN SPINEEndo TCS Driver Straight Hexalobe #6http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134071
mdprc 143 03 15 000Microtek Inc.FreedomAire Helmet Systems and Motor Modules and Smoke Evacuation Componentshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134545
mdprc 142 03 15 000Ameda, IncAmeda One-Hand Manual Breast Pump & Dual Short Term HygieniKit Milk Collections System.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134106
mdprc 141 03 15 000OssurThe Rheo Knee bionic prosthetichttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134496
mdprc 140 03 15 000In2Bones, SASDUAFIT(R) PIP 0o CA SIZE 2 & SIZE 3http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134574
mdprc 104 03 15 000Leica Microsystems, Inc.Liquid Mouse Monoclonal Antibody CD15http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132240
mdprc 102 03 15 000Penner Mfg IncPenner Patient Stretcher/Transfer Lift Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132324
mdprc 101 03 15 000Intuitive Surgical Incda Vinci Xi Surgical System, IS4000http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134524
mdprc 100 03 15 000GE Inspection Technologies, LPx|argos 160D & x|tome|x L240 X-ray systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134149
mdprc 099 03 15 000Cooper Surgical, Inc.WarmGel and Liquid Infant Heel Warmers Labeled with "PRISM Healthcare"http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133302
mdprc 085 08 14 001Cardiovascular Systems, IncDiamondback 360 Peripheral Orbital Atherectomy System.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134565
mdprc 091 03 15 000Baxter HealthcareThe HomeChoice Pro APD Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123221
mdprc 089 03 15 000Ossur.LP Rotate Foot System prosthetic devicehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134240
mdprc 088 03 15 000SIEMENSARTISTE MV Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131894
mdprc 087 03 15 000St. Jude Medical IncTactiSys Quartz Packhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133892
mdprc 079 03 15 000Synthes IncThumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX and the Thumb Screw for the Aiming Arm for Titanium Cannulated Tibial Nails-EXhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133826
mdprc 078 03 15 000Dako IncAutostainer Plus Link Instrumentshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134032
mdprc 076 03 15 000Zimmer incPersona Trabecular Metal Tibial Plateshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133978
mdprc 075 03 15 000US Infusion Inc dba Trucare Biomedix-USAMedstream 81" (206 cm) 20 drop Universal Administration Setshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132319
mdprc 074 03 15 000Puritan Medical Products Co., LLCPuritan absorbent foam tipped applicatorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132741
mdprc 073 03 15 000Med-logics IncML 7090 Calibrated LASIK Bladehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133234
mdprc 072 03 15 000Bard Access SystemsBD Posiflush Saline Flush Syringe 10 mlhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133939
mdprc 056 03 15 000Medela IncNuTrio Sterile Enteral Feeding Syringeshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134006
mdprc 053 03 15 000Synthes IncSynthes Inserter for Titanium Elastic Nailshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134076
mdprc 050 03 15 000MAQUET Cardiovascular LLCMaquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133942
mdprc 048 03 15 000Villa Radiology Systems LLCJuno DRF systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132618
mdprc 047 03 15 000Pivotal Health SolutionsApollo (cold) Laser Desktop Control Unitshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133854
mdprc 046 03 15 000Depuy OrthopaedicsSMARTSET GHV Gentamicin Bone Cementhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133929
mdprc 026 03 15 000Zipline MedicalZip 8M , Zip 8M & Zip 16http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133841
mdprc 025 03 15 000Richard Wolf The I-Carthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133375
mdprc 024 03 15 000Cooper Surgical, Inc.CooperSurgical PESSARYhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133919
mdprc 023 03 15 000Zimmer incZimmer Segmental System (ZSS) Cemented Stemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133917
mdprc 022 03 15 000Arjo Hospital Equipment AB.Rotoprone, TriaDyne Proventa Critical Care & RotoRest Delta Advanced Therapy Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133850
mdprc 016 03 15 000AngioDynamics IncStarburst MRI Semi-Flex Electrode Devicehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133427
mdprc 122 02 15 000Intuitive Surgical IncEndoWrist One Vessel Sealers Used with da Vinci Si and Xi Surgical Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133842
mdprc 115 02 15 000MAKO Surgical CorpRobotic Arm Interactive Orthopedic System (RIO).http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133374
mdprc 114 02 15 000Haemonetics Corp.Haemonetics TEG Hemostasis System Level II Controlhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133242
mdprc 113 02 15 000Cincinnati Sub-Zero Products IncCT99 Cold Therapy Padhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132502
mdprc 112 02 15 000Caesarea Medical Electronics LtdCME America BodyGuard 323 Infusion Pumpshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132890
mdprc 094 02 15 000Biomet IncRingloc Acetabular Shell Limited Hole Finned 52mmhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133703
mdprc 093 02 15 000Biomet IncMallory Head 4 Finned Acetabular Shell 50mmhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133700
mdprc 092 02 15 000SIEMENSArtis Onehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133162
mdprc 091 02 15 000Teleflex MedicalHudson RCI Sheridan / Preformed, Uncuffed Tracheal Tube, Nasalhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132631
mdprc 090 02 15 000Zimmer incGemLock Long Hex Driverhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132929
mdprc 081 02 15 000Medical Components, Inc..HEMOCATH, SLX, PROPICC, VASCUPICChttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133239
mdprc 080 02 15 000Arrow International IncARROWguard Blue PLUS Pressure Injectable Two-Lumen CVC Kitshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132409
mdprc 079 02 15 000Arrow International IncARROW Epidural Needle Componenthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132410
mdprc 065 02 15 000Virtual Imaging, Inc.Virtual Imaging RadPRO 40 kWhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130399
mdprc 064 02 15 000SIEMENSACUSON S2000 Automated Breast Volume Scanner (ABVS)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133279
mdprc 063 02 15 000SCC Soft ComputerSoftPath Laboratory Information Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131609
mdprc 062 02 15 000Radiometer America IncABL90 FLEX analyzerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132250
mdprc 061 02 15 000SIEMENSLINAC Acceleratorshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132297
mdprc 060 02 15 000Shape Medical Systems, IncShape Disposable Patient Interfacehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132323
mdprc 059 02 15 000Intuitive Surgical Incda Vinci Si Surgical System, IS3000, EndoWrist Stapler 45 Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132453
mdprc 024 02 15 000Stryker Howmedica Osteonics CorpTrident PSL HA Solid Back 50 mmhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132247
mdprc 023 02 15 000Fresenius Kabi LtdFresenius Crit Line in a Clip (CLiC)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132856
mdprc 018 02 15 000SCC Soft ComputerSoftLab laboratory information systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132127
mdprc 017 02 15 000Baxter HealthcareBaxter Integrated APD Set with Cassette 3-Pronghttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132197
mdprc 015 02 15 000Fresenius Kabi LtdHEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132221
mdprc 014 02 15 000OrthosensorVERASENSE KNEE SYSTEMhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132050
mdprc 013 02 15 000Baxter HealthcareHomeChoice/HomeChoice Pro Automated Personal Cyclerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132608
mdprc 012 02 15 000Animas Corporation Animas Vibe Insulin Infusion Pump.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130189
mdprc 008 02 15 000Innokas MedicalCARESCAPE VC150 Vital Signs Monitorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132205
mdprc 126 01 15 000AesculapAesculap Miethke Shunt Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132226
mdprc 124 01 15 000Baxter HealthcareFour Lead TUR Irrigation Sethttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132249
mdprc 123 01 15 000Fresenius Kabi LtdFresenius ASSEMBLY, POWER SUPPLY 130V 50HZhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132154
mdprc 103 01 15 000BD BiosciencesAnti-Lambda APC-H7http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132254
mdprc 102 01 15 000Stryker InstrumentsThe SurgiCounter Charging Cradlehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132241
mdprc 101 01 15 000TransMotion Medical IncPendant Controls on TMM5 Series Stretcher-Chairshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131309
mdprc 100 01 15 000SIEMENSADVIA Chemistry XPT System and the CentraLink™ Data Management Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132219
mdprc 099 01 15 000Philips HealthcareTcG10 Transcutaneous Gas Measurement Modules on IntelliVue Patient Monitorshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131452
mdprc 098 01 15 000Med Tec IncCivco, MTSR03 & MTSR02 Shoulder Retractorshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132168
mdprc 097 01 15 000Ferno Washington IncFerno Model 35X PROFlexx Stretchershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132060
mdprc 090 01 15 000Biomet Spine, LLCTimberline Anchored Lateral Variable Retractable Sleevehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132196
mdprc 084 01 15 000Stelkast CoEXp Tibial Inserthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132223
mdprc 083 01 15 000SpineFrontier IncSpineFrontier PedFuse Pedicle Screw Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132251
mdprc 082 01 15 000SIEMENSSOMATOM Forcehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132029
mdprc 081 01 15 000Ortho-Clinical DiagnosticsVITROS 5600 Integrated System, VITROS 3600 Immunodiagnostic System & VITROS 4600 Chemistry Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131874
mdprc 079 01 15 000Biocare Medical LlcMUM-1 (Multiple myeloma oncogene-1)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132108
mdprc 078 01 15 000MedtronicPOWEREASE™http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132161
mdprc 076 01 15 000GE HealthcareBrivo 715 Prime & Brivo 865 Plus Mobile C-Arm X-Rayhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131285
mdprc 035 01 15 001Trumpf Medical Systems, Inc.JUPITER Operating TablesMHRA
mdprc 060 01 15 000Stryker OrthopaedicsImbibe Bone Marrow Aspiration Needle & Imbibe Aliquot Needle Bone Cement Needlehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132062
mdprc 059 01 15 000Steris CorpHarmony vLED Surgical Lighting Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132078
mdprc 058 01 15 000Centurion Medical ProductsMultiple surgical trayshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132234
mdprc 057 01 15 000AbbottThe Abbott m2000sphttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130190
mdprc 033 01 15 000ExactechOptetrak Asymmetric Hi-Flex Posterior Stabilized Cementedhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130723
mdprc 032 01 15 000Mckesson McKesson Cardiology ECG Managementhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132318
mdprc 031 01 15 000Spinal ModulationTi-Bond Marketing Literature/Labelinghttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132185
mdprc 027 01 15 000Zimmer incTrilogy Cupshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131584
mdprc 026 01 15 000HeartSync IncMulti-function Defibrillation Electrodes Used with Philips HeartStart Defibrillatorshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132024
mdprc 011 01 15 000Zimmer incOsteobond Copolymer Bone Cementhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131930
mdprc 010 01 15 000Nonin Medical, Inc.Regional Oximetry Sensorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132186
mdprc 009 01 15 000AlereINRatio Monitors, INRatio 2 Monitors, Alere INRatio PT/INR Test Strips, Alere INRatiohttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132045
mdprc 166 12 14 000Smiths Medical20 G × 1-Inch Needle-Pro EDGE Safety Deviceshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131691
mdprc 165 12 14 000MAQUET Cardiovascular LLCMaquet QuadroxID Pediatric Diffusion Membrane Oxygenatorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131553
mdprc 164 12 14 000Unistrip Technologies LLCUniStrip1http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131711
mdprc 162 12 14 000Ebi, LlcSolitaireC Cervical Spacer Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=132064
mdprc 149 12 14 000Zimmer incPersona Cemented Tibial Broach Inserters/Extractor Handleshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131934
mdprc 148 12 14 000Zimmer incNexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guidehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131726
mdprc 147 12 14 000US EndoscopyUroSeal Adjustable Endoscopic Valve.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131574
mdprc 146 12 14 000Ortho-Clinical DiagnosticsVITROS CHEMISTRY PRODUCTS TRIG Slides.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131547
mdprc 145 12 14 000HORIBA ABX DiagnosticsLite DM (Lite Data Manager).http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131698
mdprc 144 12 14 000Cyberonics IncCyberonics VNS Therapy AspireHChttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131684
mdprc 133 12 14 000Integra LifeSciencesAscension Orthopedics PyroSphere CMC & PyroSphere TMThttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131421
mdprc 132 12 14 000Eyemart Express LtdPrescription eyeglass safety lenseshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130267
mdprc 131 12 14 000Biomet Biomet Spine Durango Anchored ALIF Plate.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131149
mdprc 130 12 14 000Medtronic LimitedAffinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive Surface.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131456
mdprc 023 09 14 001Customed, IncCustomed multiple packshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131036
mdprc 124 12 14 000Mindray DS USA, Inc., dba Datascope Patient MonitoringMindray DPM 6 and DPM 7 Monitorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131541
mdprc 123 12 14 000MAKO Surgical CorpRESTORIS PST Straight Shell Inserters and Acetabular Shell InsertersZ-0828-2015, Z-0829-2015, Z-0830-2015
mdprc 128 06 14 001JAS Diagnostics Inc.( subsidiary of ERBA Diagnostics )Glucose Hexokinase Liquid Reagenthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131170
mdprc 122 12 14 000Carestream Health Inc Div Onex CorpCARESTREAM DIRECTVIEW CRhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131396
mdprc 120 12 14 000GE HealthcareCentricity Enterprise Archive 4.0http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117004
mdprc 118 12 14 000Varian Medical SystemsVarian On-Board Imager Advanced Imaging Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131207
mdprc 117 12 14 000Stryker Spine Specialty Audible Torque Wrench for the Xia 3 Spinal Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131536
mdprc 116 12 14 000SAM Medical ProductsSAM Junctional Tourniquet (SJT) Auxiliaryhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130412
mdprc 115 12 14 000Philips Medical SystemsPhilips Healthcare Brilliance iCT/Brilliance iCThttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130286
mdprc 114 12 14 000Cure Medical LLCThe Cure Pediatric Catheter 10Frhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131446
mdprc 094 12 14 000Stryker Endoscopy1488 HD 3-Chip endoscope Camerahttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131432
mdprc 093 12 14 000Mevion Medical Systems, Inc.MEVION S250http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131530
mdprc 092 12 14 000Invacare Corporation.Perfecto 2 V Oxygen Concentratorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130540
mdprc 091 12 14 000INO Therapeutics (dba Ikaria)INOMAX DSIR Nitric Oxide delivery systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131204
mdprc 090 12 14 000ConforMISConformis iTotal CR G2 Knee Replacement Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131727
mdprc 054 12 14 000Summit Medical, Inc.Summit Industries Floor Mounted Tubestandhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131205
mdprc 052 12 14 000Bard Access SystemsGuardIVa Antimicrobial Hemostatic IV Dressinghttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131344
mdprc 046 12 14 000Cooper Surgical, Inc.CooperSurgical LEEP RADIUS LOOP ELECTRODEhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131206
mdprc 008 12 14 000Toshiba American Medical Systems IncAquilion One vision, Cardiac Function Analysishttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131461
mdprc 007 12 14 000Synthes IncSynthesTitanium Polyaxial Reduction Head for Titanium Matrix Spine Screwshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131023
mdprc 116 11 14 000Siemens Healthcare Diagnostics GmbHDimension Vista Systems HbA1c Flex Assayshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130530
mdprc 115 11 14 000RemelRemel TB Potassium Permanganatehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131196
mdprc 114 11 14 000Owens & MinorMediChoice Dual-Release Adult Folding Walkers with 5-Inch Wheelshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128647
mdprc 113 11 14 000Intuitive Surgical Incda Vinci Xi" Surgical Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131235
mdprc 097 11 14 000Synthes IncTitanium Cannulated Trochanteric Fixation Nail 170 MM Sterilehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=131346
mdprc 096 11 14 000Silver Star BrandsTransport Chair and Rollator in 1http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130754
mdprc 095 11 14 000Roscoe Medical IncRoscoe Transport Rollatorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130304
mdprc 094 11 14 000Medtronic VascularMedtronic Launcher Coronary Guide Catheterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130755
mdprc 093 11 14 000Maquet Cardiopulmonary AG.CARDIOHELP-i Systems.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130939
mdprc 061 11 14 000Zimmer incPersona Stemmed 5 Degree Cemented Tibiahttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130414
mdprc 060 11 14 000Steris CorpModel 5085 and Model 5085SRT Surgical Tableshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130736
mdprc 059 11 14 000St. Jude Medical IncResponse Fixed Curve DECA 6F 65cm CSL 2/8 Catheterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130784
mdprc 058 11 14 000Siemens Healthcare Diagnostics GmbHRapid Neg Urine Combo Panel Type 1 & Type 3 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130889
mdprc 057 11 14 000Dokitz NovoSciClear PAY Connectorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130883
mdprc 056 11 14 000Davol, Inc.Bard® PerFix Light Plughttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130721
mdprc 030 11 14 000Terumo Cardiovascular Systems CorporationCardioplegia Solution Administration Kitshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98878
mdprc 028 11 14 000Merit Medical Systems IncMerit Maestro Microcatheterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130706
mdprc 027 11 14 000Joerns Healthcare LtdJoerns EasyCare Bedhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130433
mdprc 026 11 14 000Coloplast Manufacturing Coloplast Conveen Urine Collection Leg Baghttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130457
mdprc 013 11 14 000Tecan Freedom EVO-2 100 Base Unit, with Air LiHa Armshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130313
mdprc 012 11 14 000Siemens Healthcare Diagnostics GmbHSiemens Dimension Phenytoin Flex Reagent Cartridgehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130331
mdprc 011 11 14 000Merge Healthcare Corp.Merge Hemo Programmable diagnostic computerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130438
mdprc 010 11 14 000Cooper Surgical, Inc.Blunt Hurd Cannula Blunt Tip 10mm with 5mm Reducerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130631
mdprc 005 11 14 000Briggs Medical Service CompanyDMI Rollator Transport Chairhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117032
mdprc 019 06 14 001C P MedicalMonoswift PGCLhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130358
mdprc 115 10 14 000Trumpf Medical Systems, Inc.TITAN Operating Tableshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130513
mdprc 104 10 14 000Vygon CorporationBionector Needleless connectorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129862
mdprc 103 10 14 000St. Jude Medical Inc10F Fast-Cath Trio" Hemostasis Introducerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130765
mdprc 102 10 14 000Signal Medical CorporationSymmetric Total Knee Femoral Componentshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130498
mdprc 101 10 14 000OlympusVarious Everest and PKS Forceps and Scissorshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129976
mdprc 100 10 14 000Estill Medical Technologies, IncEstill Ultra Battery 1 Batteries Used with Thermal Angel Blood and IV Fluid Warming Deviceshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130149
mdprc 099 10 14 000Intra Pump Infusion SystemsCRN Crono Syringehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122569
mdprc 098 10 14 000Philips HealthcarePhilips IntelliVue Monitors & Philips Avalon Monitorshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130270
mdprc 097 10 14 000Philips Respironics CaliforniaEsprit V1000 Ventilator, V200 Ventilatorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130205
mdprc 086 10 14 000Zimmer incContinuum Hip Cupshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130191
mdprc 085 10 14 000DeRoyal Industries IncSuction canisters & SafeLiner Suction Canister Kithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130223
mdprc 081 10 14 000Arjo HuntleighMaxi Sky 2 Medium 2 Point Spreader Barhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114969
mdprc 080 10 14 000Arrow International IncMulti-Lumen Central Venous Catheterization Kithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130176
mdprc 073 10 14 000Merge Healthcare CorpeFilm Workstationhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130185
mdprc 072 10 14 000KCI USA IncV.A.C. GranuFoam Silver Dressinghttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130310
mdprc 092 09 14 001Peters SurgicalThe synthetic non-absorbable surgical sutures CARDIOFLON Evolutionhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128565
mdprc 032 10 14 000OrthoHelix Surgical Design IncMaxLock Extreme Mod-Foot Concave Reamerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130183
mdprc 031 10 14 000Richard-Allan ScientificRichard-Allan 10% Neutral Buffered Formalin Reagent Productshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130173
mdprc 030 10 14 000Biomet IncGreen Mamba Suture Passer, Mamba Disposable Nitinol Needle & Black Mamba Suture Passerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130294
mdprc 029 10 14 000Boston Scientific LtdStarMedTec LightTrail Reusable Fibershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130434
mdprc 028 10 14 000Smith & Nephew incRENASYS EZ/ RENASYS EZ Plushttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129744
mdprc 027 10 14 000Nemschoff Chairs, IncSerenity Treatment Chairhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129616
mdprc 022 10 14 000Biomedix, Inc.Biomedix SELEC-3 I.V.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130088
mdprc 019 10 14 000Ortho-Clinical DiagnosticsVITROS Chemistry Products PHYT (Phenytoin) Slideshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129618
mdprc 018 10 14 000Baxter HealthcareSPECTRUM Pumphttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129683
mdprc 017 10 14 000Zimmer incPersona The Personalized Knee Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129382
mdprc 015 10 14 000Philips Medical SystemsThe Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scannershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129995
mdprc 008 10 14 000Nanosphere, Inc.Verigene GramPositivehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128491
mdprc 007 10 14 000Lumenis IncArray LaserLinkhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129733
mdprc 006 10 14 000Apollo Endosurgery IncLAP-BAND AP SYSTEMhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129727
mdprc 060 08 11 001Spacelabs Healthcare IncPatient monitor, Spacelabs Medical Patient Monitorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129983
mdprc 108 09 14 000Philips Medical SystemsBrilliance CT System 6/10/16/16P/40http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129682
mdprc 107 09 14 000Pdg Product Design Group IncFuze Manual Tilt Wheelchairhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129375
mdprc 106 09 14 000Horiba ABX PENTRA Magnesium RTU Reagenthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129650
mdprc 105 09 14 000Dako North America IncDako Autostainer Link 48http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129827
mdprc 104 09 14 000Alcon Laboratories Inc.eye-pak 7407http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128029
mdprc 093 09 14 000Vidacare CorporationEZ-LO 45 mm Needle Sethttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126593
mdprc 090 09 14 000Instratek IncorporatedMini Cannulated Titanium Headed and Headless Screw Sethttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126167
mdprc 089 09 14 000Genesys Orthopedic SystemsThe TiLock Pedicle Screw Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126582
mdprc 088 09 14 000Fresenius Fresenius Naturalyte Liquid Bicarbonate Concentratehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129774
mdprc 087 09 14 000CareFusion CareFusion AirLife Heated Infant Breathing Circuithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129107
mdprc 086 09 14 000Motion Concepts TRx Vertical Positionerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129660
mdprc 085 09 14 000Genesis BPS, LLC.Pedi-Pak Pedi-Syringe Filterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128913
mdprc 084 09 14 000CareFusionEnVe and ReVel Ventilatorshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129356
mdprc 067 09 14 000GF Health ProductsZenith Slide W-I-D-E Long Term Care Bedhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129450
mdprc 056 09 14 000JK Products & Services, IncSUN DASH RADIUS 252http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129379
mdprc 055 09 14 000Fresenius Medical CareMultiple BD Vacutainer Tubeshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128269
mdprc 054 09 14 000Dawning Technologies, IncProVue Instrument Driver for JResultNethttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129603
mdprc 053 09 14 000BD BiosciencesBD BBLTM Vancomycin Screen Agarhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129481
mdprc 050 09 14 000AB SCIEX AB SCIEX API 3200MD" LC/MS/MS System with software: MultiQuantMD 3http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129611
mdprc 049 09 14 000Pioneer Surgical TechnologyStreamline MIS Spinal Fixation Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129377
mdprc 048 09 14 000Concentric Medical IncMerci Retrieverhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129669
mdprc 038 09 14 000Zimmer incNatural-Knee System Patella Bushings.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129110
mdprc 030 02 14 001Spacelabs Healthcare IncARIATELE TELEMETRY TRANSMITTERhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129684
mdprc 037 09 14 000Medical Components, Inc.Split Cath IIIhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129216
mdprc 036 09 14 000Galt Medical CorpGalt Valved Tearaway Kit & Galt VTIhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129056
mdprc 035 09 14 000Catheter Connections, Inc.DualCap IV Pole Strips Disinfectant Caps for Luer Access Valveshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129487
mdprc 034 09 14 000Biomet 3i IncBellatek Encode Healing Abutmenthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129004
mdprc 027 09 14 000Pioneer Surgical TechnologySTREAMLINE CT CERVICO-THORACIC SYSTEMhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129374
mdprc 026 09 14 000Hitachi Medical SystemsHitachi Echelon Oval MRI systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128607
mdprc 025 09 14 000Biomet IncTotal Temporomandibular Joint Replacement Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125711
mdprc 024 09 14 000OrthoPediatrics CorpSleeve Installation Tool Instrumenthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129442
mdprc 022 09 14 000Civco Medical Instruments IncCollectEVAC Evacuator Irrigation/Tissue Collection Systems.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129097
mdprc 142 08 14 000Zimmer incPersona Distal Valgus Alignment Guides.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128765
mdprc 128 08 14 000Philips Medical SystemsPhilips IntelliSpace ECG Management Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129200
mdprc 094 08 14 001TomoTherapy IncorporatedTomoTherapy Treatment System, Model: Hi-ArtBfArM
mdprc 123 08 14 000Synthes IncCraniomaxillofacial (CMF) Distraction Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126898
mdprc 107 08 14 000Vascutek LimitedGelweave (TM) Vascular Prostheseshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129138
mdprc 106 08 14 000Medtronic NeuromodulationActiva PChttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129036
mdprc 105 08 14 000Hyperion MedicalHyperBlue 1530, multiuse diode laserhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126389
mdprc 104 08 14 000AngioDynamics IncUniFuse Infusion System with Cooper Wirehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129196
mdprc 092 08 14 000Siemens Healthcare Diagnostics GmbHDimension Chemistry Wash..http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128853
mdprc 090 08 14 000OMNIlife scienceApex Arc Hip Stem, Size 2, HA Coatedhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128142
mdprc 089 08 14 000Biomet IncVanguard 360 Revision Knee Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129028
mdprc 087 08 14 000Nanosphere, Inc.Nanosphere Verigenehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128801
mdprc 086 08 14 000Covidien LLCVital Sync Virtual Patient Monitoring Platform and Informatics Managerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128766
mdprc 076 08 14 000Medical Positioning IncRapid Response HUT table with Dual 2 Way Drop Sectionhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128617
mdprc 064 08 14 000Boston Scientific LtdENDOTAK RELIANCE SGhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128470
mdprc 062 08 14 000Nanosphere, Inc.Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127104
mdprc 061 08 14 000Intuitive Surgical IncEndoWrist Stapler System User Manual Addendum and Wall Charthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128783
mdprc 059 08 14 000ICU Medical, IncTranspac Trifurcated monitoring kit with Safeset Reservoirhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129164
mdprc 054 08 14 000Enhancement Medical, LLCEnhancement Medical expressionhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128288
mdprc 053 08 14 000Biosound Esaote, IncEsaote PA230E Transducerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128485
mdprc 039 08 14 000Medical Action Industries IncLaceration and Suture Kitshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128221
mdprc 024 08 14 000X Spine Systems IncSerrated Soft Tissue Shieldshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128882
mdprc 023 08 14 000Zimmer incZimmer Periarticular Locking Plate Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128400
mdprc 022 08 14 000Nidek Co. Ltd.MC500 Multicolor Laser Photocoagulatorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128624
mdprc 021 08 14 000Small Bone Innovations 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Setshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127716
mdprc 020 08 14 000AdvanDx, IncAdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128635
mdprc 019 08 14 000Stryker Medical InTouch Critical Care Bedshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127981
mdprc 018 08 14 000Terumo Cardiovascular Systems CorporationTerumo Advanced Perfusion System 1http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127207
mdprc 012 08 14 000Novocol, IncSelf-Etch bondhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128750
mdprc 011 08 14 000DeRoyal Industries IncDeRoyal Cardiac Hypothermia Tray & DeRoyal KNEE ARTHROSCOPY PACKhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128592
mdprc 010 08 14 000Wellspring Pharmaceutical CorporationIPM Wound Gelhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128183
mdprc 009 08 14 000Ra Medical Systems IncPHAROS Excimer Laserhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128486
mdprc 008 08 14 000Teleflex MedicalEmerald Fiber-Optic Macintosh 4 Laryngoscope Bladeshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128606
mdprc 134 07 14 000Heartsine TechnologiesPadPak and PediPak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and 350P)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128482
mdprc 133 07 14 000Dynarex CorporationCPR Shield With One Way Valve and Barrier Filterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128445
mdprc 132 07 14 000Medtronic IncNexdrive Micropositioning Drives Used with Nexframe Stereotactic Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128310
mdprc 080 11 13 001Terumo Cardiovascular Systems CorporationSarns" SoftFlow Aortic Cannula without Suture Flange & Venous Return Cannulaehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127519
mdprc 128 07 14 000Teleflex MedicalHudson RCI, Breathing Circuithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128577
mdprc 123 07 14 000Invacare Corporation.Invacare Pronto M41 Power Wheelchairhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128337
mdprc 122 07 14 000DIABETIC SUPPLY OF SUNCOAST, INC.Advocate RediCode BMB-BA006A Blood Glucose Test Stripshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127125
mdprc 121 07 14 000Alphatec Spine IncSolanas 2.1mm FIXED DEPTH DRILL, 10mmhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128421
mdprc 095 07 14 000Stryker EndoscopyDisposable StrykeFlow Tipshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128339
mdprc 093 07 14 000Spacelabs Healthcare IncSpacelabs Healthcare Ultraview SL Multigas Modulehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128308
mdprc 092 07 14 000Pioneer Surgical TechnologyTritium Sternal Plate Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128318
mdprc 091 07 14 000International Technidyne CorporationHemocrhon Jr APTT Cuvetteshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128402
mdprc 090 07 14 000Baxter HealthcareBaxter MiniCap with ProvidoneIodine Solutionhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128280
mdprc 085 07 14 000Excelsior Medical CorpSterile Triple Lead Tubing Set and Sterile Heavy Duty Triple Lead Tubing Sethttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128242
mdprc 084 07 14 000Innovasis, IncExcella II Standard Pedicle Screwhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128657
mdprc 076 07 14 000SIEMENSSymbia E & E.CAM Emission Computed Tomography Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128464
mdprc 075 07 14 000Philips Medical SystemsGemini TF 16 PET/CT; Gemini RF 64 PET/CT; Gemini TF Big Borehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128391
mdprc 074 07 14 000Zimmer Manufacturing B.V.4.0mm X 20mm Cancellous Screw; 4.0mm X 22mm Fully Threaded Screwhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128171
mdprc 073 07 14 000Hospira IncThe Hospira MedNet Medication Management Suite (MMS).http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128401
mdprc 072 07 14 000Zimmer incM/L Taper and M/L Taper with Kinectiv Hip Stemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127546
mdprc 071 07 14 000Thermo Fisher Scientific Inc.Thermo Scientific VersaTREK REDOX 1http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128265
mdprc 069 07 14 000Zimmer incZimmer Dental Tapered Screw-Vent Implanthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128266
mdprc 068 07 14 000Shape Medical Systems, IncShape HF Cardiopulmonary Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128263
mdprc 059 07 14 000Integra LifeSciencesNewPort Spinal System MIS Rod 2http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128087
mdprc 058 07 14 000B Braun Medical IncStopcock Extension Setshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128169
mdprc 056 07 14 000Philips Medical Systems Ingenia 3.0T , Ingenia 1.5T R5, Ingenia 3.0T R5 , Ingenia 1.5T Magnetic Resonance Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128277
mdprc 044 07 14 000Vascular Technology, Inc.VTI BAYONET DOPPLER PROBES & VARIOUS MIZUHO DOPPLER PROBEShttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128115
mdprc 043 07 14 000RGI Medical Manufacturing, Inc.Henora Catheter Extension Sethttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128179
mdprc 042 07 14 000Kova Laboratories, IncAmerigel Wound Dressinghttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128030
mdprc 041 07 14 000CenorinHLD Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128261
mdprc 040 07 14 0003M company3M Attest Auto-readerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127541
mdprc 039 07 14 000Intuitive Surgical IncMultiple Da Vinci Surgical Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128006
mdprc 038 07 14 000Global Cooling IncStirling Ultracold Portable Shuttlehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127369
mdprc 037 07 14 000Focus Diagnostics IncSimplexa Flu A/B &38; RSV Directhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127387
mdprc 036 07 14 000Baxter HealthcareEXACTAMIX Compounderhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128106
mdprc 030 07 14 000Ventlab CorpResuscitator Bags, manual resuscitator for the Pediatric Populationhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127204
mdprc 029 07 14 000Stryker Howmedica Osteonics CorpStryker Orthopaedics Triathlon Tritanium Patella Inserterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128089
mdprc 028 07 14 000Synthes IncSynthes B37 Replacement Screwshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127496
mdprc 027 07 14 000Integra LifeSciencesIntegra® LED Battery Chargerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128129
mdprc 026 07 14 000Boston Scientific CorporationiLab Ultrasound Imaging Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126666
mdprc 023 07 14 000Claymount AssembliClaymount Harmony2 Buckyhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126135
mdprc 021 07 14 000Alcon Research, LtdAlcon CUSTOM-PAKhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127370
mdprc 020 07 14 000Zimmer incNexGen Complete Knee Solution MIS Total Knee Procedure Stemmed Tibial Component, Precoathttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127984
mdprc 019 07 14 000Spacelabs Healthcare IncQube Compact Monitorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128034
mdprc 018 07 14 000Siemens Healthcare DiagnosticsADVIA Centaur, ADVIA Centaur XPhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128153
mdprc 017 07 14 000Meridian Bioscience Incillumipro-10 Incubator/Readerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127512
mdprc 016 07 14 000Integra LifeSciencesAccell Evo3c Demineralized Bone Matrix Putty 5 cchttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127361
mdprc 015 07 14 000Blue Belt TechnologiesStride Femoral Componenthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128024
mdprc 132 06 14 000The Anspach Effort, Inc.Multiple Anspach systems deviceshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115697
mdprc 130 06 14 000Stryker EndoscopyShaver Handpiece Sterilization Trayhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127531
mdprc 129 06 14 000Nitinol Devices and Components, Inc.HydroFinity Guidewireshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127555
mdprc 127 06 14 000Intuitive Surgical IncIS4000 da Vinci Xi - Endoscope accessoryhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128147
mdprc 105 06 14 000Teleflex MedicalRUSCH, LaserTube (Rubber), Laser Resistant Tracheal Tubehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127500
mdprc 104 06 14 000Philips HealthcarePhilips Brilliance CT Big Bore Oncology and Philips Brilliance CT Big Bore Radiology http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126548
mdprc 102 06 14 000Integra LifeSciencesIntegra UCR 3mm Hex, Large Axial Driverhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127469
mdprc 082 06 14 000Spacelabs Healthcare IncHamilton Galileo Ventilator Flexporthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127487
mdprc 081 06 14 000Ability Dynamics LLCRUSH81 Prosthetic Foothttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128151
mdprc 072 06 14 000Smiths MedicalPortex Low Dead Space Connector with Sideport, 3.5mmhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126747
mdprc 071 06 14 000Ebi, LlcCypher MIS Screw Inserterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128143
mdprc 070 06 14 000Ortho-Clinical DiagnosticsCalibrator Kit 17 and FS Calibrator 1 Used with VITROS Chemistry Products hsCRP Reagentshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127271
mdprc 069 06 14 000Boston Scientific CorporationIntellaTip MiFi XP Temperature Ablation Cathetershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127481
mdprc 068 06 14 000Biomet IncEZPass Suture Retriever Nitinol Single Pack, EZPass Nylon Monofilament Single Pack & EZPass Passerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127167
mdprc 166 02 14 001Elekta LimitedSynergy xray volume imaging (XVI); Elekta Synergy; Elekta Synergy S and XVIhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125047
mdprc 057 06 14 000Teleflex MedicalTaut Operative Cholangiogram Catheter, 4.5FR (1.5mm) x 76cmhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127366
mdprc 056 06 14 000Cooper Surgical, Inc.Cooper Surgical TAMPA CATHETER 5 French 33 cmhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127327
mdprc 055 06 14 000Cenorin HLD Systems (High Level Disinfector)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127201
mdprc 054 06 14 000Philips HealthcareIntelliVue MX40 Patient Monitors used with IntelliVue Information iX Centershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127391
mdprc 053 06 14 000Ortho-Clinical DiagnosticsenGen (TM) Laboratory Automation Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127243
mdprc 052 06 14 000Cordis CorporationCordis EMPIRA RX PTCA Dilatation Catheterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115742
mdprc 051 06 14 000Cincinnati Sub-Zero Products Inc115 V Blanketrol II, Model 222S Hyper-Hypothermia Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127458
mdprc 042 06 14 000Teleflex MedicalRUSCH Easy Cathhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127390
mdprc 041 06 14 000Mckesson Information Solutions LLCHorizon Medical Imaginghttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127692
mdprc 039 06 14 000AlereAlere Triage D-Dimer Testhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127185
mdprc 038 06 14 000Stryker Instruments The Stryker NAV3i Platform & The NAV3i Platform Power Boxhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127233
mdprc 037 06 14 000Medtronic Neuromodulation Ascenda Intrathecal Catheterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127290
mdprc 036 06 14 000Intuitive Surgical IncAssembly, Patient Side Cart, for use with da Vinci Surgical system IS 4000http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127460
mdprc 020 06 14 000Spacelabs Healthcare IncUltraview SL Command Modulehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127459
mdprc 013 06 14 000Bacterin International, IncElutia Surgical Wound Drainhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127311
mdprc 012 06 14 000Synthes IncSynthes XRL Medium TrialCentral Bodyhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126770
mdprc 009 06 14 000Fresenius Medical CareNaturaLyte Bicarbonate Concentrate Bottleshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126614
mdprc 003 06 14 000DePuySynthesProDisc-C 2.0mm Milling Bithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127119
mdprc 001 06 14 000B Braun Medical Inc.Sprotte Spinal Tray / Sprotte Spinal Needle 24 gaugehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126847
mdprc 105 05 14 001Microline Surgical IncMicroline Renew Fenestrated Control Tip GrasperBfArM
mdprc 122 05 14 000SIEMENS550 TxT Treatment Table of the Digital Linear Accelerator (LINAC)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126663
mdprc 121 05 14 000Philips HealthcarePhilips XRE, the dictation editor system included in the Philips XIRIS 8.1.50http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127235
mdprc 120 05 14 000Medline Industries Inc.Esmark Elastic Bandage http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126504
mdprc 119 05 14 000GambroRevaclear and Revaclear Max Capillary Dialyzershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126757
mdprc 118 05 14 000FUJIFILM Medical SystemsMXR-35 Diagnostic X-ray High Voltage Generatorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126664
mdprc 108 05 14 000True Air Technologies, IncECATS E 850 and JK Bariatric Bedhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126957 , http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126617
mdprc 107 05 14 000True Air Technologies, IncMaXair True Low Air Loss Mattress Replacement Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126958
mdprc 106 05 14 000Terumo Cardiovascular Systems CorporationCDI Blood Parameter Monitoring System; CDI 500 Monitorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127202
mdprc 104 05 14 000Arrow International IncArrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Catheterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126459
mdprc 096 05 14 000CareFusion..Alaris Pump Model 8100http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126894
mdprc 095 05 14 000Mindray North AmericaDPM 6 Monitorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126625
mdprc 094 05 14 000Medline Industries Inc.Mucus Specimen Traphttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123381
mdprc 093 05 14 000The Anspach Effort, Inc.Anspach Irrigation Clip 40http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126801
mdprc 092 05 14 000InterValve IncInterValve V8 Balloon Aortic Valvuloplasty Catheterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126670
mdprc 091 05 14 000Baxter HealthcareRAPIDFILL Syringe Striphttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126818
mdprc 090 05 14 000Fresenius Medical CareFresenius 2008T Hemodialysis Machinehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126850
mdprc 089 05 14 000McKesson Medical Imaging GroupPicture Archive Communication System (PACS)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=127138
mdprc 088 05 14 000Ortho Development CorpPS-C Femoral Nonporous Rt Sz 6http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126817
mdprc 081 05 14 000Tenex HealthTX1 Tissue Removal System, TX1 Procedure Pack, TX1 MicroTiphttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126906
mdprc 080 05 14 000Mar Cor PurificationCentral Water Platform (CWP), 102, 104 and 106http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126959
mdprc 079 05 14 000AlloSource, IncAlloFuse DBM Putty 5cchttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126738
mdprc 076 05 14 000Zimmer inc " Knee Brace, Cartilage Knee Brace, Hinged Knee Support, Tennis Elbow Supporthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126805
mdprc 071 05 14 000Newport Medical Instruments Inc.Newport Medical Instruments e360 Ventilatorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126938
mdprc 059 05 14 000AlereINRatio 2 PT/INR Professional Test Stripshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126845
mdprc 024 05 14 000Biorep TechnologiesJoseph Lamelas Atrial Lift Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126934
mdprc 015 05 14 000INO Therapeutics (dba Ikaria)INOmax DSIR Delivery Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126644
mdprc 010 05 14 000Hospira IncACCLAIM Encore Infusion Pumpshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125798
mdprc 009 05 14 000Arrow International IncArrowgard Blue Plus Antimicrobial Multilumen Central Venous Catheterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126460
mdprc 006 05 14 000Alfa Wassermann, Inc.ACE AST Reagent Kitshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126580
mdprc 096 08 13 001Fisher Scientific CoWood Applicator Swab, Fisherbrand Sterile Swab, Calcium Alginate Fiber Tipped.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120307
mdprc 161 04 14 000Teleflex MedicalMonodek Violet Synthetic Absorbable Surgical Sutureshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126704
mdprc 160 04 14 000Acumed LLCThe Acumed Tension Band Pin & The Osteo-Clage Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126602
mdprc 152 04 14 000Branan Medical CorporationToxCup Drug Screen Cuphttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126393
mdprc 151 04 14 000Philips Medical SystemsPhilips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 softwarehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126532
mdprc 150 04 14 000Teleflex MedicalTubes, Sengstaken Tube and Sengstaken-Blakemore Tubehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125902
mdprc 149 04 14 000Ion Beam Applications S.A.Proteus 235 Proton Therapy Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126051
mdprc 148 04 14 000Zimmer incTRABECULAR METAL" MODULAR ACETABULAR SYSTEMhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126336
mdprc 147 04 14 000Arrow International IncPressure Injectable PICC Powered by Arrow VPS Stylethttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126455
mdprc 146 04 14 000StrykerPenAdapt Aspiration Sheaths Used with Neptune 2 Ultra Rover Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126202
mdprc 145 04 14 000Ortho-Clinical DiagnosticsVITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125634
mdprc 138 04 14 000Merit Medical Systems IncMerit Laureate Hydrophilic Guide Wirehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126848
mdprc 137 04 14 000Hospira IncHemoSet Dual-Channel PlumSet Blood Administration Setshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126148
mdprc 131 04 14 000Spacelabs Healthcare IncAnesthesia Systems , Arkon Anesthesia Delivery Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126320
mdprc 119 04 14 000Ortho-Clinical DiagnosticsVITROS Chemistry Products CRBM Slides.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126327
mdprc 117 04 14 000Codman & Shurtleff IncCODMAN CERTAS" Programmable Valveshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126333
mdprc 116 04 14 000Terumo Cardiovascular Systems CorporationTerumo Cardiovascular Procedure Kit- X-Coated Pump and Table Packhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126616
mdprc 115 04 14 000SIEMENSAXIOM Vertix MD Trauma systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126309
mdprc 114 04 14 000CareFusion Inc,SmartSite Extension Setshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126255
mdprc 113 04 14 000Philips Medical SystemsComputed Tomography X-ray systems, Ingenuity Core 128http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126256
mdprc 112 04 14 000Biomet 3i IncEndosseous Dental Implanthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125833
mdprc 111 04 14 000Newport Medical Instruments IncNewport HT70 and HT70 Plus Ventilatorshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111914
mdprc 109 04 14 000Synthes IncSynthes CMF Battery Powered Driverhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125578
mdprc 093 04 14 000Ergosafe Products LLCMedcare Lift with Scale Medcare Lift w/Scale 600 lb Scale Hanger Assemblyhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126363
mdprc 092 04 14 000GambroHemodialysis Tubing Sets, Gambro Cartridge Blood Set blood transport systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126338
mdprc 090 04 14 000Central Purchasing LLC DBA Harbor Freight ToolsSit/stand Rolling Walkerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126545
mdprc 089 04 14 000Remington MedicalFAS-LOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Downhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126209
mdprc 082 04 14 000Teleflex MedicalRusch Brochopart and Rusch Brochopart Whitehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125870
mdprc 081 04 14 000Aspen Surgical Products, Inc.Multiple drain Kitshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126229
mdprc 074 04 14 0003M Health Care Ltd3M Steri-Vac Gas Sterilizer/Aeratorshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126136
mdprc 073 04 14 000Ormco Corp.Titanium Orthos Bracketshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126506
mdprc 072 04 14 000StrykerProstheses, Joint, Hip, Femoral Component, Citation TMZF Hip Stemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126186
mdprc 071 04 14 000Energizer Personal CarePlaytex Nurser Deluxe Double Electric Breast PumpZ-1336-2014
mdprc 070 04 14 000Intuitive Surgical Inc5 mm Cannulae Used with da Vinci Si Surgical Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126237 , http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126239 , http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126240 , http://www.accessdata.fda.
mdprc 069 04 14 000Merit Medical Systems IncMerit Custom Syringe Kit & Pressure Monitoring Tubinghttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126485 , http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126484
mdprc 068 04 14 000Ormco Corp.Spirit MB Brackethttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126492
mdprc 018 04 14 000Allesee Orthodontic AppliancesDistalizer Lock Nut Screwhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125897
mdprc 003 04 14 000Abbott Laboratories Inci-STAT G3+ Reagent Cartridgeshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125647
mdprc 002 04 14 000Biocardia, Inc.Catheter Introducerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126128
mdprc 001 04 14 000Bard Access SystemsPowerPort Slim Implantable Porthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125727
mdprc 140 03 14 000Gyrus ACMIDisposable Falope-Ring Band Kitshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125747
mdprc 139 03 14 000Teleflex MedicalMultiple sutures with Needle Attachmentshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126183
mdprc 135 03 14 000ConvaTecCurion CuriStay Nelaton, Medline Sterile Foley Catheter, 'TORAY' Hydrocoat Foley Catheter, SLC 2-way standard Lubricious, JMS, SLC 3-way standard Lubricioushttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126152
mdprc 130 03 14 000Velocity Medical Solutions, LLCDICOM Export Format for Sum Dose with Velocity v3.0.0http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125842
mdprc 129 03 14 000Leica Microsystems, Inc.Microscopes, ScanScope Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125499
mdprc 128 03 14 000Stryker Communications2.5MM Aggressive Blade Known as a Sinuscopic Shaver Bladehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126273
mdprc 127 03 14 000Philips HealthcareUltrasound Systems, EPIQ 7http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126067
mdprc 125 03 14 000Clarity Medical Systems IncHalogen Lamp component in RetCam 3 Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126097
mdprc 124 03 14 000Biomet IncIntramedullary Bone Sawhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125847
mdprc 122 03 14 000Zimmer incVarious Polyethylene Prostheseshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125635
mdprc 118 03 14 000Terumo Cardiovascular Systems CorporationSarns Malleable Dual-stage Venous Return Cannulae, Cathetershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125812
mdprc 023 03 14 001Medical Information Technology, Inc.IVD, MEDITECH Microbiologyhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125769
mdprc 117 03 14 000ExactechGibralt Spine System Polyaxial Screw Intended to promote fusion of the cervical spine, and the thoracic spine, (C3-T3).http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125540
mdprc 107 03 14 000China Daheng Group Inc.Denlase and Penlase Dental Laser Systems.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125664
mdprc 085 03 14 000Elekta LimitedSL & SLi Series (Mod 15/18/20/25) Linear Acceleratorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118950
mdprc 084 03 14 000DeRoyal Industries Inc.DeRoyal(R) LIMB HOLDERS, COTTON ADJUSTABLEhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126065
mdprc 064 08 11 003Vital Signs Inc A GE Healthcare CoVital Signs enFlow IV Fluid Warmershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103330
mdprc 053 03 14 000Philips Respironics Trilogy Ventilator Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125712
mdprc 052 03 14 000Steris CorpVERIFY SixCess 270FP Challenge Packhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125270
mdprc 051 03 14 000Boston Scientific CorporationBoston Scientific, RunWay" Guide Catheterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125921
mdprc 048 03 14 000Mindray North AmericaPanorama Central Station Patient Monitoring Systems.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125558
mdprc 047 03 14 000Megadyne Medical Products IncHand Control 12FR Suction Coagulator with 10 ft cord and holsterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125887
mdprc 046 03 14 000Hospira IncLifeShield Latex-Free HEMA Y-Type Blood Set IV Administration Setshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124587
mdprc 045 03 14 000GE HealthcareMonitor, GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Patient Monitors, Dash Port2 Docking Station.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125349
mdprc 044 03 14 000GE HealthcareComputed Tomography X-Ray system, GSI Viewerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121519
mdprc 040 03 14 000Toshiba American Medical Systems IncTSX-301C Aquilion One (Vision Edition)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125035
mdprc 039 03 14 000KCI USA IncWound Dressing Connectors Used with Prevena Incisional Management Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125480
mdprc 038 03 14 000MEDICAMAT S.A.Punch Hair Matichttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125432
mdprc 037 03 14 000DJO SurgicalFMP X-alt Acetabular Linerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125512
mdprc 036 03 14 000AlterG, IncorporatedAlterG Anti-Gravity Treadmillhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125448
mdprc 035 03 14 000DeRoyal Industries Inc.Circumcision Clampshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125456
mdprc 034 03 14 000Synthes IncSynthes 5.0mm Variable Locking Screwhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125573
mdprc 033 03 14 000MAKO Surgical CorpRestoris Multicompartmental Knee (MCK) Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125464
mdprc 035 02 14 001CareFusionSmartSite Needle-Free Connectorshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00119-1
mdprc 022 03 14 000Toshiba American Medical Systems IncMultiple Aquilion Computed Tomography X-Ray Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122559
mdprc 020 03 14 000WalkMed Infusion, LLCTriton FP Infusion Pumphttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125700
mdprc 013 03 14 000Philips Medical SystemsPhilips HeartStart XLhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125534
mdprc 012 03 14 000OssurThe SYMBIONIC LEGhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125090
mdprc 011 03 14 000Philips HealthcareDefibrillators, HeartStart MRx Monitor / Defribillatorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125533
mdprc 010 03 14 000Philips Medical SystemsDefibrillators, Philips HeartStart XL+ Defibrillator/Monitorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125269
mdprc 009 03 14 000Fresenius Medical CareFresenius Optiflux F160NRe, F200NRe , F200NR, F200A, B200, F180NR, F160NR, F180NRe and F18Nre Flux Dialyzershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125235
mdprc 007 03 14 000Philips HealthcarePhilips HeartStart MRx Monitor/Defribillatorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125539
mdprc 006 03 14 000Stryker Spine Straight Static Inserter Assembly MFG Part of the AVS navigator Peek Spacer Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125385
mdprc 167 02 14 000NxStage Medical, Inc.NxStage PureFlow-B Solutionhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125408
mdprc 165 02 14 000Merit Medical Systems IncProcedure Trays, Merit Medical's Custom Procedural Trayshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123393
mdprc 148 02 14 000Bausch & Lomb IncAKREOS AO Micro Incision Lenshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125149
mdprc 147 02 14 000Synthes IncSynthes Driving Cap/Threadedhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125106
mdprc 146 02 14 000Medline Industries IncGuidewire .035x150 3MMJ TCFC used in a number of surgical convenience kitshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121458
mdprc 145 02 14 000Terumo Cardiovascular Systems CorporationVirtuoSaph Plus - Endoscopic Vessel Harvesting Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124916
mdprc 144 02 14 000Smith & Nephew incReflection(R) Interfit(TM) Shell, 52 MM OD, 3 HOLEhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125406
mdprc 137 02 14 000Perrigo Diabetes CareOrbit soft Infusion setshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124793
mdprc 136 02 14 000Biocardia, Inc.MORPH ACCESSPRO Steerable Introducerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125554
mdprc 135 02 14 000The Standing CompanySuperstand stand-up wheelchair HPS-2http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124663
mdprc 134 02 14 000Aesculap, Inc.proSA Adjustment Disc Size Large (L)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124863
mdprc 120 02 14 000Siemens Hearing Instruments, IncSiemens Prisma 2K Hearing Aidhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125067
mdprc 099 02 14 000Medtronic IncGrafton DBM Flex Bone Graft Materials.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125127
mdprc 091 02 14 000Boston Scientific- Coyote MONORAIL PTA Balloon Dilatation Catheter
- 2.5mm Coyote OVERTHEWIRE PTA Balloon Dilation Catheter
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125452
mdprc 089 02 14 000Tandem Diabetes Care, IncSyringes, t:slim Insulin Cartridgeshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125111#
mdprc 073 02 14 000RTI Surgical, IncOPTEFORM Allograft Pastehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125083
mdprc 072 02 14 000Integra LifeSciencesMalibu Polyaxial Screwdriverhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125305
mdprc 069 02 14 000OrthoPediatrics Corp3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mmhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125200
mdprc 068 02 14 000StrykerGaymar Medi-Thermhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123805
mdprc 067 02 14 000OssurThe Symbionic Leghttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125089
mdprc 046 02 14 000CareFusionTrifurcated Extension Sethttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125294
mdprc 040 02 14 000Siemens Healthcare Diagnostics-ADVIA Centaur Systems Phenytoin Calibrator N ( PHTN) 2pack
-ADVIA Centaur Systems Phenytoin Calibrator N ( PHTN) 6pack
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124531

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124759
mdprc 039 02 14 000B Braun Medical Inc.AccuFlo Elastomeric Infusion Pump 200ML/H 100 MLhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124860
mdprc 038 02 14 000ExactechInteGrip Acetabular Augmenthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125015
mdprc 037 02 14 000Edwards Lifesciences26mm transcatheter heart valve crimperhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125336
mdprc 034 02 14 000Horiba Instruments, IncABX PENTRA N Controlhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124157
mdprc 033 02 14 000Medtronic Advanced Energy, LLCAquamantys3 Pump Generatorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123689
mdprc 031 02 14 000Merit Medical Systems IncMerit RAD BOARDhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124977
mdprc 029 02 14 000Synergetics IncMultiple illuminators & chandeliershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124930
mdprc 028 02 14 000Boston Scientific LtdAtlantis PV 15 MHz Peripheral Imaging Catheterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125181
mdprc 026 02 14 000Carestream Health IncCarestream DRX Evolution System (Standard Q)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124636
mdprc 025 02 14 000Philips HealthcarePhilips Brilliance CT systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122030
mdprc 088 03 13 001Synthes IncSynthes Titanium Midface Distractor,osteotomyhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115763
mdprc 020 02 14 000Acute Innovations LLcACUTE Innovations Ribloc U plus Rib Fracture Plating Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124733
mdprc 019 02 14 000Zimmer incTapered ScrewVent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platformhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124976
mdprc 018 02 14 000Kimberly-Clark CorporationKimberlyClark RadiOpaque Radiofrequency Cannulahttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123686
mdprc 017 02 14 000Philips HealthcareBrilliance iCT and iCT SPhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125215
mdprc 111 01 14 000Churchill Medical Systems7 Microbore Trifurcated Extension Sethttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125099
mdprc 110 01 14 000GE HealthcareVital Signs Breathing Circuits.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124805
mdprc 109 01 14 000Ortho-Clinical DiagnosticsVITROS Chemistry Products COCM Reagentshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122450
mdprc 108 01 14 000Bard Access Systems-Titanium Single Lumen Low Profile port, with Pre-Attached Open-Ended Silicone 6.6Fr Catheter.
- MRI Low Profile Single Lumen port with OpenEnded 6.6Fr Silicone Catheter
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124442
mdprc 107 01 14 000Navilyst MedicalPort Kit with Access Infusion Sethttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124740
mdprc 087 01 14 000Sorin GroupORCHESTRA/ORCHESTRA PLUS Programmerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124518
mdprc 079 01 14 000SpineFrontier IncArena-L Trials (Handles and Heads)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121960
mdprc 078 01 14 000Ranir CorporationTopCare Clifford THE BIG RED DOG power toothbrush for kids and UP & UP kids power toothbrush1) http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124742
2)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124741
mdprc 077 01 14 000SIEMENSSIMVIEW NT and SIMVIEW NT with IDIhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124791
mdprc 063 01 14 000SIEMENSSiemens syngo.plazahttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120166
mdprc 062 01 14 000Vital Diagnostics, Inc.Consult Diagnostics® Eon Calcium Reagent For In-Vitro Diagnostic Usehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122398
mdprc 060 01 14 000GE HealthcareMerge (Cedara) Mammohttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118680
mdprc 058 01 14 000Zimmer incPalacos® R+G Radioplaque 1x40 g Single (with Gentamicin) Bone Cementhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124437
mdprc 057 01 14 000The Anspach Effort, Inc.Short Carbide Cutting Burs.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124773
mdprc 052 01 14 000Midmark CorpVantage Panoramic X-Ray System firmware versions: 3.0, 3.1, 3.2, and 3.3.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122704
mdprc 051 01 14 000Biomet IncLocking Cortical Screw 3.5mmX38mmhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124768
mdprc 050 01 14 000The Anspach Effort, Inc.Anspach MCA Cutting Burrhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124873
mdprc 048 01 14 000King Systems Corp.King Systems KLTSD414 airwayhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124329
mdprc 047 01 14 000Boston Scientific LtdBoston Scientific Extractor Pro XL Retrieval Balloon Catheterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124763
mdprc 035 01 14 000On Site Gas Systems Inc.Portable Oxygen Generation System, POGS 33Chttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124750
mdprc 034 01 14 000Smiths Medical, IncSyringes,Smiths—29 G Hypodermic Needle-Pro Fixed Needle Insulin Syringeshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124579
mdprc 031 01 14 000Fresenius Medical CareHemodialysis Machines, 2008 Serieshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122784
mdprc 022 01 14 000RTI Surgical, IncWebless implants , C-Plushttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124694
mdprc 020 01 14 000Materialise USA LLCprosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer, Signaturehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124626
mdprc 019 01 14 000SpineFrontier IncPedFuse Bone Probehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121928
mdprc 018 01 14 000Trans American Medical, IncWireless Footswitch/Handswitch system, Spectrehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121427
mdprc 017 01 14 000Carestream Health Inc Div Onex CorpDRX Revolution Mobile Xray Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123275
mdprc 016 01 14 000AesculapAesculap Hi-Line XXS handpiecehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124615
mdprc 015 01 14 000GE HealthcareCentricity Laboratory Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117106
mdprc 005 01 14 000Steris CorpSYSTEM 1E Liquid Chemical Sterilant Processing Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124471
mdprc 004 01 14 000Zimmer inc.CPT Hip System, Trabecular Metal (TM) Reverse Glenosphere,http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124349
mdprc 003 01 14 000Merit Medical Systems IncCatheter, Maestro Microcathetershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124756
mdprc 194 12 13 000Terumo Cardiovascular Systems Corporation.Valves, Overpressure Safety Valves Contained in Cardiovascular Procedure Kitshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124644
mdprc 193 12 13 000Philips Medical SystemsMonitor/Defibrillator, Philips HeartStart MRxhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124617
mdprc 192 12 13 000Baxter HealthcarePharmacy Compounding Device (PCD), IntelliFill i.v.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124685
mdprc 188 12 13 000SpineFrontier IncIndus Invue Screwshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124182
mdprc 186 12 13 000OrthoPediatrics CorpACL Reconstruction System Installation toolshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124474
mdprc 185 12 13 000Philips Medical SystemsMonitor/Defibrillators, Philips HeartStart MRxhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124606
mdprc 091 02 13 001Thermo Fisher DiagnosticsIVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Legionella Species, Oxoid Legionella BCYE Growth Supplement Reagentshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114256
mdprc 168 12 13 000SpineFrontier IncReset Screw Inserters, PedFusehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123912
mdprc 167 12 13 000B Braun Medical IncIntrocan Safety PUR Intravenous Cathetershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122558
mdprc 166 12 13 000Integra LifeSciencesMonitors, Bedside, Intracranial Pressure , Integra Cranial Access Kithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124276
mdprc 165 12 13 000CareFusionModel 8000 and 8015 Alaris PC Unit Infusion Pump Systems.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123822
mdprc 164 12 13 000Qualigen IncIVD : Immunoassay, FastPackhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123729
mdprc 163 12 13 000CooperVision Inc.Contact lenses, Proclear & ClearSighthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124134
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124133
mdprc 162 12 13 000ASI Medical, IncSEAC Advanced Dental Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124413
mdprc 161 12 13 000SpineFrontier IncPedFuse Reset Screwhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123002
mdprc 160 12 13 000Arrow International IncContinuous Peropheral Nerve Block Catheter Kit and Sethttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122660
mdprc 149 12 13 000Hospira IncInfusion Pumps, SYMBIQ OneChannel and TwoChannel Infusershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121914
mdprc 148 12 13 000Baxter HealthcareMedical software, ABACUS TPN Calculation Softwarehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124436
mdprc 147 12 13 000Remel IncIVD, Remel Streptex Group D Latex Reagents.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119040
mdprc 146 12 13 000Remel IncIVD Test Reagent/Kits, Microbiology, Remel RapID Yeast Plus System Reagentshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119041
mdprc 145 12 13 000Nephros IncWater purification, Nephros SafeSpout and SafeShowerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123218
mdprc 127 12 13 000GE HealthcareGE CO2 Multi Absorber Original, Disposablehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122872
mdprc 119 12 13 000Aesculap IncBipolar Coagulator, GNI161 Bipolar Foot Controlhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122555
mdprc 118 12 13 000Zimmer incStemmed Tibial Component Precoat, NexGen Complete Knee Solutionshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123053
mdprc 117 12 13 000Steris CorpSteam sterilizer Transfer Carriage, AMSCO Evolutionhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123916
mdprc 116 12 13 000Stryker Howmedica Osteonics CorpStryker cancellous Bone Screwhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=124144
mdprc 101 12 13 000Zimmer incTrabecular Metal Total Ankle Tibial Base and Talus Componentshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123120
mdprc 100 12 13 000Synthes USA (HQ) Inc.Trochanteric Fixation Nailhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122353
mdprc 090 12 13 000Cutera LtdMassager, Vacuum, radio frequency induced heat, truSculpt infrared Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122929
mdprc 087 12 13 000Synthes IncNails, Bone , TFN Titanium Trochanteric Fixation Nail Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122361
mdprc 086 12 13 000Centurion Medical ProductsRubber Bands, Centurion Sterile 84 Rubber Bandshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123693
mdprc 085 12 13 000Karl Storz Forceps, Axillent Debakey Grasping Forcepshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123575
mdprc 084 12 13 000Ethicon Endo Surgery IncSTRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122798
mdprc 177 08 13 001Zimmer incImplants , NexGen Complete Knee Solutionhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123523
mdprc 083 12 13 000Synthes IncZeroP VA Implant 7 MM Height Parallel Sterilehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122562
mdprc 082 12 13 000GE HealthcareCentricity Web Softwarehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117060
mdprc 055 12 13 000Cincinnati Sub-Zero Products IncData Export Software, Blanketrol IIIhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122858
mdprc 053 12 13 000CareFusionLow Sorbing Infusion Set with Texium Close Male Luer, SmartSitehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123304
mdprc 050 12 13 000CareFusion Inc,Intravascular Administration Set, VersaSafe Extension Sethttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123294
mdprc 043 12 13 000Philips Healthcare Universal Fluoroscopic applications, Easy Diagnost Elevahttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123097
mdprc 017 12 13 000B Braun Medical IncIntravenous Fluid Containers, addEASE Binary Connectorshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118620
mdprc 016 12 13 000Ebi, LlcShortened Plug Driver, Biomet The Polaris Spinal SystemDriverhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122904
mdprc 015 12 13 000Synthes USA (HQ) Inc.Synthes Vertebropasty Needle Kit 10g Diamond Tiphttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122358
mdprc 014 12 13 000Synthes USA (HQ) Inc.Synthes 2.4 mm LCDCP Plate 6 Holes/51mmhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122357
mdprc 013 12 13 000Synthes USA (HQ) Inc.Synthes 4.5 mm LCP Curved Condylar Platehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122362
mdprc 012 12 13 000Custom Ultrasonics, IncEndoscope Washer/Disinfector, Custom Ultrasonics System 83 Plus 2 and Plus 9http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121143
mdprc 009 12 13 000Synthes Inc14.5 mm Outer Protection Sleeve for Suprapatellarhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122646
mdprc 008 12 13 000Lanx, IncStraight Split Tip Driver Short ( Driver ), Timberline MPF Lateral Modular Plate Fixation Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123690
mdprc 189 11 13 000Toshiba American Medical Systems IncScanning Systems, Ultrasonic, Aplio XG and Xario XG Diagnostic Ultrasound Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121395
mdprc 188 11 13 000Baxter HealthcareVIAL-MATE Adaptershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122241
mdprc 175 11 13 000Synthes IncTensioning Devices Used with Distraction Osteogenesis Ring Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122364
mdprc 174 11 13 000Synthes IncNails, Bone , Large Buttress Compression Nuts for Blade Guide Sleeve TFN Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122365
mdprc 173 11 13 000Mindray DS USA, Inc., dba Datascope Patient MonitoringPatient Monitor, V Series Monitorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123285
mdprc 170 11 13 000Biomet IncCarpal Tunnel Security Bladeshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123472
mdprc 169 11 13 000Mizuho Mizuho Sugita Titanium Standard Aneurysm Clip IIhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122611
mdprc 165 11 13 000Ergosafe Products LLCTotal Support, patient stand, Medcare Products Max500 Standhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121494
mdprc 163 11 13 000Teleflex MedicalDisposable Metal Larynogoscope Blade, Green RuschLitehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122874
mdprc 155 11 13 000Biomet 3i IncDrill Bit, The Juggerknotless Soft Anchorshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122873
mdprc 154 11 13 000StrykerModel FL14E Rose Bedshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121538
mdprc 153 11 13 000EBI LP Sub Biomet IncPolaris Translation Screw Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121961
mdprc 152 11 13 000Wexford LabsReady-to-Use THYMO-CIDE Disinfectant Solutionhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122245
mdprc 151 11 13 000Synthes IncRetractors, Orthopedic , Soft Tissue Retractorshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122552
mdprc 150 11 13 000Riverpoint Medical, LLCPolyglycolicLactic Acid Absorbable Surgical Suturehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119650
mdprc 149 11 13 000Candela CorporationCandela Laser GentleLase Prohttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123370
mdprc 148 11 13 000Spacelabs Healthcare IncPatient Monitor, qube Compacthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123184
mdprc 147 11 13 000Trumpf Medical Systems, Inc.Surgical Table, TruSystemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122967
mdprc 146 11 13 000Stryker Sustainability SolutionsEletrophysiology Catheter; BARD,Daig,BW CristaCath,Response,Supreme,Qwik Cable,BW Webster, Carto 3http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123045
mdprc 015 09 13 001Zimmer incDistractors, Surgical, Shoulder , Trabecular Metal Reverse Glenosphere Distractor Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119862
mdprc 097 08 13 001Zimmer incTrabecular Metal Reverse Glenosphere Helmetshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119375
mdprc 136 11 13 000Stryker Acetabular Pressurizerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122400
mdprc 135 11 13 000Beckman Coulter IncAccess 2 Immunoassay Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122247
mdprc 134 11 13 000SpineFrontier IncExtension Shims, S-LIFThttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120086
mdprc 133 11 13 000OrthoPediatrics Corp3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MMhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122418
mdprc 123 11 13 000Philips Medical SystemsComputed Tomography XRay System, Brilliance iCThttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122697
mdprc 122 11 13 000DeRoyal Industries IncSurgical Eye Spearshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122717
mdprc 121 11 13 000ConMed CorporationThermal Tissue Fusion, ALTRUShttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122579
mdprc 120 11 13 000Carl Zeiss Meditec IncOphthalmic device, IOLMaster http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122862
mdprc 114 11 13 000The Anspach Effort, Inc.BlackMax Motor Systems, MicroMax Motor Systems, XMax Motor Systems, EMax2 Motor Systems, Emax2Plus Mhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120536
mdprc 113 11 13 000Integra LifeSciencesMAYFIELD Composite Series Skull Clamphttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122417
mdprc 112 11 13 000GlaxoSmithKline Biotene Moisturizing Mouth Sprayhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122970
mdprc 094 11 13 000CareFusion..CareFusion Gravity Set , used to administer fluid and medication through a needle or catheter inserted into the patient's artery or veinhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121572
mdprc 087 11 13 000Mesa Laboratories, IncpH 7.0 Buffer Solutionhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122454
mdprc 086 11 13 000SeppimCalcium Arsenazo, CALA0250http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122064
mdprc 085 11 13 000Pinook-UsaPinook Mini & Micro Massagerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122609
mdprc 083 11 13 000Carestream Health Inc Div Onex CorpDRX Revolution Mobile Xray System.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121430
mdprc 082 11 13 000Baxter HealthcareSigma Spectrum Infusion Pump component (LCD screen)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122243
mdprc 081 11 13 000Urologix IncRF Therapy , Prostiva Hand Piece Kithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122692
mdprc 079 11 13 000Spacelabs Healthcare IncVital Signs Monitor, elancehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123183
mdprc 078 11 13 000Fresenius Medical CareCombiset Bloodlineshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121293
mdprc 077 11 13 000Baxter HealthcareSIGMA SPECTRUM Infusion Pumps with Master Drug Libraryhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121520
mdprc 075 11 13 000St. Jude Medical Inc.Safire Duo Ablation Catheter MediGuide Enabledhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122638
mdprc 060 11 13 000Ethicon IncGastroplasty Bands , REALIZE Adjustable Straight Gastric Bandshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122437
mdprc 059 11 13 000Handicare LtdBath Lifts , Handicare USA's Minivator Bath Bliss Reclining Bath Lifts (Bath Bliss), handsethttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114924
mdprc 058 11 13 000Baxter Healthcare.Dual Luer Lock Capshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121842
mdprc 057 11 13 000Steris CorpEquipment Management System, Harmonyhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121539
mdprc 056 11 13 000St. Jude Medical Inc.US Safire Duo Ablation Catheter MediGuide Enabled, Cool Path Duo Ablation Catheterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122676
mdprc 055 11 13 000Smiths MedicalSpinal Anesthesia Trays, Portexhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122134
mdprc 054 11 13 000Insulet CorporationInsulin Management System Starter Kit & Demonstration Kit, OmniPodhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122397
mdprc 044 11 13 000Richard Wolf S(a)line resectoscopes BiPolar Vaporization Electrodeshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122427
mdprc 043 11 13 000Insight Instruments IncOphthalmic singleport illumination, MLS Torpedo MiniLighthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121305
mdprc 042 11 13 000Bayer Healthcare LLCA1cNow+ Multi-Test A1c System 20-Test Kitshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121482
mdprc 041 11 13 000Edwards LifesciencesDuraflo coated Dispersion Tip Arterial Cannulae & coated FemFlex Arterial Cannulahttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121500
mdprc 037 11 13 000Smith & Nephew NONPOROUS TIBIAL BASE, GENESIS(R) SIZE 6, RIGHT & SIZE 5, LEFThttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122572
mdprc 036 11 13 000EKOS CorpEKOS EkoSonic Control Unithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122511
mdprc 034 11 13 000Baylis Medical CorpTransseptal Guiding Sheath, TorFlexhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122172
mdprc 019 11 13 000Zimmer incFemoral Fixation System S/C Plates, Ti-Magna Fx Washer, Ti-Versa FX IIhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121736
mdprc 018 11 13 000Medtronic NeuromodulationVarious Implantable Neurostimulatorshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122448
mdprc 016 11 13 000Carestream Health Inc.Radiographic Units, Mobile, DRX-Revolution Mobile X-Ray Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119661
mdprc 012 11 13 000Carestream Health Inc. DRX Revolution Mobile XRay Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120273
mdprc 009 11 13 000Carestream Health Inc Div Onex CorpDRX-Revolution Mobile X-Ray Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119011
mdprc 007 11 13 000Globus Medical, IncMicroFuse Bone Void Fillerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121916
mdprc 106 05 13 002Merit Medical Systems IncPerforma® Cardiac Multipackhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122251
mdprc 151 10 13 000Atossa Genetics, IncForeCYTE Breast Health Test and the Mammary Aspiration Specimen Cytology Test (MASCT)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122387
mdprc 149 10 13 000Depuy OrthopaedicsMedium Viscosity Antibiotic Bone Cement, SmartSet GMV Endurancehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121889
mdprc 148 10 13 000SIEMENSImaging ultrasound systems, Acuson SC2000http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120286
mdprc 141 10 13 000DeVilbiss Healthcare LLCSuction Unit , DeVilbiss Vacu-Aide QSU ,(Disposable Suction Container/Filter), 800 MLhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122122
mdprc 140 10 13 000Sysmex America IncAutomated Hematology Analyzer , pocH-100ihttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119961
mdprc 139 10 13 000AesculapSurgical Instruments , supported arm , UNITRAC Pneumatic Retraction Armhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121001
mdprc 138 10 13 000Convergent Dental Laser Surgical instrument , Solea 1.0http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122154
mdprc 093 10 13 000SonoSite IncTransducer , P21x/5-1 MHzhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122088
mdprc 092 10 13 000Opti Medical Systems IncIVD , OPTIMedical Cassettes ,http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121489
mdprc 089 10 13 000Siemens Healthcare Diagnostics IncIVD ,reagent , Dimension Vistahttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117107
mdprc 088 10 13 000Sekisui DiagnosticsOSOM BVBlue Rapid Test Kitshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121955
mdprc 087 10 13 000Harvest HealthcareDelivery System , Harvest Grafthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121918
mdprc 065 10 13 000Bard Pcripheral Vascular (BPV)LIFESTENT Solo Vascular Stent Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122212
mdprc 057 10 13 000Maquet Cardiopulmonary AGCardiac surgery instruments , Ultima OPCAB Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122158
mdprc 055 10 13 000Instrumentation LaboratoryCoagulation, reagent, HemosIL RecombiPlasTin 2Ghttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118777
mdprc 133 02 13 001CareFusionSmartSite®® Gravity Blood Sethttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115553
mdprc 045 10 13 000AMS Innovative Center - San Jose.Laser Delivery Systems, Fiberoptic, GreenLight HPS and XPShttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115154
mdprc 026 10 13 000Mckesson Information Solutions LLCRadiological Image Processing System , Horizon Medical Imaginghttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121962
mdprc 025 10 13 000Hologic IncDigital Mammography System , Seleniahttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121704
mdprc 024 10 13 000ASO, LLCWaterproof Adhesive Pads Antibacterial , SHOPKOhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=122141
mdprc 023 10 13 000H and H Medical CorpEmergency Cricothyrotomy Kitshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121529
mdprc 014 10 13 000Synthes USA (HQ) IncDistal Humerus System , Synthes 3.5 MM LCPhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117661
mdprc 013 10 13 000King Systems Corp. Breathing Circuit , Universal Flex2http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121659
mdprc 004 10 13 000Synthes USA (HQ) Inc.Vertebral body replacement device , Oracle Spacer System Slap Hammer .http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115645
mdprc 003 10 13 000Spine Smith Holdings, LLCMedical apparatus , spinal fusion devices , VISUALIFhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121169
mdprc 001 10 13 000CareFusionInfusion Set , SmartSite Low Sorbinghttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121570
mdprc 116 09 13 000Smiths Medical ASD Inc.PORT-A-CATH and PORT-A-CATH II Implantable Venous Access Systems Introducer Sets.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121805
mdprc 115 09 13 000Microgenics CorpIVD , DRI Cocaine Metabolite Assay labeled as Multigent Cocaine Assay for Abbott Laboratorieshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120699
mdprc 114 09 13 000Maquet Cardiopulmonary AGQUADROX Oxygenators, Holding Clamps, and Tubing Pack Productshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121375
mdprc 113 09 13 000Invacare CorporationPower Wheelchair , Invacare .http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118605
mdprc 112 09 13 000Endoplus, Inc.Precision Laparoscopic Instruments , Endoplus Single Action Inserthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121426
mdprc 106 09 13 000GE HealthcareX-Ray Imaging System , Discovery IGS 730 Cardiovascularhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121602
mdprc 105 09 13 000Access Scientific IncCatheter , POWERWAND Safety Introducer with Extended Dwell Catheterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121781
mdprc 104 09 13 000Rauland-Borg CorpNurse call communication system , Responder 5http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119829
mdprc 103 09 13 000Cincinnati Sub-Zero Products IncHyper/Hypothermia System , Blanketrol IIIhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121580
mdprc 014 01 13 001Hill Rom IncLiko Standard Slingbar 450http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110438
mdprc 091 09 13 000Villa Radiology Systems LLCJuno DRF System. Mobile X-ray systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121286
mdprc 090 09 13 000Medtronic Sofamor Danek USA IncRemoval driver, T8 Removal Driver for the CD Horizon Spire and Spire Z Spinal Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121220
mdprc 089 09 13 000AssuramedIVD ,ProTime Microcoagulation System,DiaScreen Liquid Urine Controls, Hemoccult II SENSA elitehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121133
mdprc 088 09 13 000Lumenis IncVision One Laser Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121534
mdprc 087 09 13 000Edwards LifesciencesSensor , single use kit , FloTrac Sensorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121142
mdprc 086 09 13 000CareFusionThoracentesis and Safe-T Thoracentesis Drug-Free Trays.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121524
mdprc 085 09 13 000Cardiogenesis Corporationhandpieces , fiberoptics , Cardiogenesis Transmyocardial the SoloGrip III (HP-5G3) and the PEARL 5.0 (HP-PRL5).http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121314
mdprc 061 09 13 000Roche Diagnostics LtdIVD , KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVDhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121300
mdprc 060 09 13 000Covidien LLCFlush syringe , Monojecthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121123
mdprc 056 09 13 000Berchtold CorpSurgical Table , D850http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121072
mdprc 050 09 13 000Baxa CorpVial Adapter http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121455
mdprc 049 09 13 000B Braun Medical Inc Infusion System , Outlook Safety Infusion System Burette Sethttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121164
mdprc 042 09 13 000Stelkast Co Distal Femoral Augment with Screw , SC2316http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120308
mdprc 041 09 13 000MicroAire Surgical InstrumentsK-Wire and Steinmann Pin Productshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121296
mdprc 032 09 13 000Roche Diagnostics LtdB-CrossLaps/serum ,ELECSYS®-CrossLaps/Serum Immunoassayhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118059
mdprc 025 09 13 000SpineNetSpineNet Anterior Cervical Cage , Lordotic, Peek (originally submitted as Daytona Anterior Cervical Cage)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120864
mdprc 024 09 13 000SpineNetSpineNet Anterior Cervical Cage , Lordotic, Peek (originally submitted as Daytona Anterior Cervical Cage)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120864
mdprc 023 09 13 000SIEMENSC-arm angiographic x-ray system , Axiom Artishttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120167
mdprc 022 09 13 000Medtronic Inc Cardiac Rhythm Disease Management Divperfusion systems , Custom Perfusion System with Trillium BioSurface (a polymer containing non-leaching heparin)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120358
mdprc 021 09 13 000DeRoyal Industries Inc Laparoscopic , Insufflation Tubing setshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120078
mdprc 020 09 13 000Alphatec Spine IncScrew , lllico Ti Cannulated Polyaxial Screw 7.5mm X 40mmhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119844
mdprc 019 09 13 0003M Company / Medical DivisionCrown , Unitek Primary Stainless Steel Crownshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120837
mdprc 014 09 13 000Zimmer incFemoral Hip , Free Lock Femoral Fixation Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120083
mdprc 013 09 13 000Synthes IncPlates, Bone, 2.4 mm VA-LCP 2-Column Volar Distal Radius Plates Used with 1.2 Nm Torque-Limiting Attachmenthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119565
mdprc 012 09 13 000Synthes USA (HQ) Inc.Plate , Bone , Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Righthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120724
mdprc 008 09 13 000Philips HealthcareRadiographic system , Philips Easy Upgrade DRhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120999
mdprc 007 09 13 000Mckesson Information Solutions LLC Anesthesia , Mc Kesson Anesthesiahttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120087
mdprc 006 09 13 000Life Technologies CorporationIVD , Reagents , HSV-2 Primershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120130
mdprc 005 09 13 000Integra LifeSciencesClamps, Skull, Leyla Ball Joint Clampshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120309
mdprc 004 09 13 000Fresenius Medical CarePump , 2008 MeDS Pump, Venofer(R) Pumphttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117850
mdprc 006 02 13 001Ethicon Endo Surgery IncThe ENSEAL® G2 Tissue Sealers ,Electrosurgical Unitshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115291
mdprc 175 08 13 000Micro Therapeutics IncCatheter , endovascular treatment, Pipeline Embolization Devicehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120283
mdprc 174 08 13 000GE HealthcareComputed Tomography X-ray System , LightSpeed CT750 HDhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118572
mdprc 162 08 13 000Stryker CommunicationsLights, Examination, Visum 300 Ceiling - Mounted Examination Lightshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120723
mdprc 161 08 13 000Philips HealthcareRadiography, MobileDiagnostwDR system, ile Digital radiography X-Ray Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120442
mdprc 160 08 13 000Getinge Disinfection ABGetinge Assure AccuFast Biological Indicators (BIs) are designed for biological testing of 121®C, 132®C, 134®C and 135®C steam sterilization cycles.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120574
mdprc 159 08 13 000Blue Belt TechnologiesMonitor Drape REF: PFSD-V0001, Rx only, Sterilehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120387
mdprc 154 08 13 000Medicel AGInjector System, nanoPOINT Injector Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120811
mdprc 153 08 13 000Sorin GroupEdwards Lifesciences Suction Wand , packaged in Sorin Group Heart/Lung Perfusion Packs.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120616
mdprc 152 08 13 000Atrium Medical CorporationPleuraGuide Disposable Chest Tube Kithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119863
mdprc 151 08 13 000GE HealthcareThe Discovery NM/CT 570c CT Standalone Scan The Discovery NM/CT 570c hybrid systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120193
mdprc 150 08 13 000Aspen Surgical Products, Inc.Reinforced Wound Closurehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120111
mdprc 144 08 13 000Gyrus ACMIGYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, Sterile EO. GYRUS ACMI, REF 3740PK, or REF 94201PK, PKS LYONS, Dissecting Forceps 5mm/45cm, Sterile EO.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120141
mdprc 142 08 13 000Zimmer incProstheses,Moore Long Fenestrated Stem Hip Prostheseshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120360
mdprc 141 08 13 000Terumo Cardiovascular Systems CorporationHeart-Lung Bypass Units , Advanced Perfusion System 1http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119873
mdprc 140 08 13 000Endogastric Solutions IncProstheses, Gastroesophageal, Antireflux, EsophyX2http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120509
mdprc 139 08 13 000Boston Scientific Cardiac Rhythm Management GroupCardioverter Defibrillator.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120194
mdprc 138 08 13 000SIEMENSFluoroscopic X-Ray system , Luminos dRFhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119218
mdprc 137 08 13 000Siemens Medical SolutionsLinear accelerators, Siemens ARTISTE, ONCOR and PRIMUS systems.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117486
mdprc 131 08 13 000Terumo Cardiovascular Systems CorporationPumps, Extracorporeal Perfusion, Heart-Lung Bypass Units, Advanced Perfusion System 1http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119861
mdprc 130 08 13 000Terumo Cardiovascular Systems CorporationAdvanced Perfusion System 1http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118618
mdprc 129 08 13 000Medtronic Inc Cardiac Rhythm Disease Management DivPediatric filter , Affinity Pediatric Arterial Filter,http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119981
mdprc 128 08 13 000Epocal IncIVD , epoc BGEM Test Cardhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117928
mdprc 127 08 13 000Arrow International IncCatheter , Arrow Two-Lumen CVC Kit with Blue Flex Tip Catheterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120336
mdprc 099 08 13 000SpineFrontier IncScrewdriver , Tipped Tapered Solid Driverhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117613
mdprc 098 08 13 000SpineFrontier IncSurgical instruments , Case Lid and Base (Inspan, Invue, SLIFT) Caddy Lid (Inspan, Arena-C)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117565
mdprc 090 08 13 000Synthes IncPedicle screw spinal system , USS Small Staturehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119580
mdprc 089 08 13 000SIEMENSAngiographic system , AXIOM Artis zeego x-rayhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119960
mdprc 088 08 13 000OrthoPediatrics CorpOrthoPediatrics PediLoc Locking Plate System , 3.2mm Drill Bithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120334
mdprc 087 08 13 000Nova Biomedical CorporationNova Max Glucose Test Stripshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120658
mdprc 086 08 13 000Medtronic Xomed IncTray Surgical , ENT ( various instrument trays )http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120407
mdprc 085 08 13 000GE HealthcareUltraSound Imaging , LOGIQ S8http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119647
mdprc 078 08 13 000SpineFrontier IncT-Handle, Strike Plate,http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117599
mdprc 077 08 13 000SpineFrontier IncSpinal fusion , Invue Split Driver, Assembly with Handlehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119841
mdprc 076 08 13 000SpineFrontier IncScrew , Indus Invue Screw Caddyhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119818
mdprc 075 08 13 000SpineFrontier IncScrew inserter (screwdriver - orthopedic manual surgical instrumenthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117582
mdprc 074 08 13 000Mitsubishi Heavy Industries Ltd.Radiation therapy , MHI-TM2000 Linear Accelerator Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120158
mdprc 073 08 13 000Aspen Surgical Products, Inc.Surgical Tape Strips , Meijer Wound Closure Adhesive Surgical Tape Strips , Walgreens ("W" and "Well at Walgreens") , Duane Reade (DR) , Premier Value , Discount Drug Mart , TopCare , HEB , Leaderhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120302
mdprc 072 08 13 000American Optisurgical IncHand pieces, Surgical, TX1 Tissue Removal System.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107666
mdprc 049 08 13 000SIEMENSImaging , mobile X-ray , MIRAhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119699
mdprc 048 08 13 000Hospira Inc IVD sets , Blood Set , Y-Type Blood Set , Plum Blood Set , Secondary Blood Set .http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119891
mdprc 044 08 13 000SpineFrontier IncDrill Guide (guide, surgical, instrument)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117583
mdprc 043 08 13 000Precision Medical.Non-sterile Viscot Surgical Skin Markershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119963
mdprc 031 08 13 000Wako ChemicalsReagent cartridge , uTASWako DCPhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117873
mdprc 030 08 13 000Tosoh CorporationIVD , Analyzer, AIA Analyzer Pipettehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119615
mdprc 029 08 13 000SpineFrontier IncS-LIFT Slap Hammerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117721
mdprc 028 08 13 000SpineFrontier IncCaddy - PedFuse, Screw Caddyhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117585
mdprc 027 08 13 000SIEMENSPicture Archiving and Communication, Radiology , syngo Dynamics Information Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119697
mdprc 026 08 13 000GE HealthcareUltrasound System., LOGIQ ehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120062
mdprc 025 08 13 000GE Medical SystemsUltrasound Systems , VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIChttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=120056
mdprc 024 08 13 000ExactechNon powered hand-held device , Articulated Driverhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119601
mdprc 023 08 13 000Accelerated Care Plus Corporationpowered exercise equipment intended for medical purposes , Omnicycle Elitehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119317
mdprc 019 08 13 000Synthes USA (HQ) Inc.Drill Guide , Synthes Synapse SDhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119839
mdprc 018 08 13 000Synthes USA (HQ) Inc.Synthes Large External Fixation, MR Conditionalhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119840
mdprc 017 08 13 000StrykerCORE and RenB Universal Drivershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118956
mdprc 015 08 13 000Steritec Products MfcCardinal BI Stat Biological Test Pack with Instant Readout Integratorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119713
mdprc 012 08 13 000Custom Spine, IncSpinal Fixation System , Custom Spine ISSYS LP Inverted Screw System http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117828
mdprc 202 07 13 000AesculapAesculap PEEK Intervertebral Body Fusion Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119939
mdprc 201 07 13 000SIEMENSAXIOM Aristos MX X-Ray Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119698
mdprc 200 07 13 000Haemonetics CorpIVD , Coagulation Analyzer , Thromboelastograph Instrumenthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119790
mdprc 198 07 13 000Church & Dwight IncSodium Bicarbonate, USP Provided bulk as raw materialhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119877
mdprc 197 07 13 000Becton Dickinson & Co. (BD)IVD , BD Affirm VPIII Microbial Identification Tests http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119730
mdprc 181 07 13 000St. Jude Medical IncCharging System , Eon - 3701 (Wall Charger) and 3711 (Portable Charger) , Eon Mini - 3721 (Charger).http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115091
mdprc 180 07 13 000Steris CorporationSTERIS Fine Traction Device , used to to provide traction and enable fine adjustments to traction and orientation of the leg during orthopedic procedures.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119612
mdprc 179 07 13 000SIEMENSAngiograph , Artis zee / zeegohttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119815
mdprc 178 07 13 000Pemco IncSurgical retractor , Rultract Retractor Ratchet Cover Platehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119864
mdprc 177 07 13 000Hill Rom IncBeds, AccuMax Quantum Mattresses Used with TotalCare Bed Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118400
mdprc 175 07 13 000Cardio Medical ProductsECG Electrode , Cardio Medical Productshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118978
mdprc 167 07 13 000Myoscience Inc A Cryogenic Surgical device, ioverahttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119527
mdprc 163 07 13 000Synthes IncMulti Vector Distractor Pin Holding Clamphttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119576
mdprc 162 07 13 000Staar Surgical CoIntracellular lens , NanoFLEX CC4204Ahttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119567
mdprc 161 07 13 000SpineFrontier IncScrew , spinal system , Rods - Pedicle screw spinal systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117587
mdprc 160 07 13 000Physio Control IncDefibrillator , LIFEPAK 500 Automated Externalhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119584
mdprc 159 07 13 000Philips HealthcareMonitors, Central Station, IntelliVue Smart-Hoppinghttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119750
mdprc 158 07 13 000Integra LifeSciences CorporationNail systems , PANTA Arthrodesis Nail Support Devicehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118787
mdprc 157 07 13 000Carl Zeiss Meditec IncDiagnosis by color variation , , Polarizer D Fixed w/Rotating Red 1 lambda platehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118619
mdprc 155 07 13 000Boston Scientific CorporationCatheter , Alair Bronchial Thermoplasty Catheterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118510
mdprc 154 07 13 000Baxter HealthcareEXACTAMIX Compounders with DY Display Moduleshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118289
mdprc 121 06 13 001Respironics IncVentilators, V60 VentilatorFDA
mdprc 125 07 13 000Biomet IncOxford Fixed Bearing Partial Knee Replacement , Cemented Lateral Tibiahttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119065
mdprc 123 07 13 000Terumo Cardiovascular Systems Corporation Blood Parameter Monitoring System , CDI 500http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105527
mdprc 122 07 13 000Synthes IncSynthes CMF Distraction Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119842
mdprc 121 07 13 000SagaTech Electronics, Inc.Sleep recorder , Remmers (formerly SnoreSat)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119816
mdprc 120 07 13 000KooJoo Trading CompanySafety Lancets - Odyssey, Button Activated; Tri- Bevel Tip for Virtually Painless Sampling; Needle automatically retractshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119830
mdprc 119 07 13 000Karl Storz Endoscopy UK Ltd27023WU Balloon Catheterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119378
mdprc 118 07 13 000Fresenius Medical CareHemodialysis machines , Service Replacement 0-Ring. Used in as a service part in 4 sub-assemblies manufactured and/or refurbishedhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117864
mdprc 117 07 13 000DeRoyal Industries IncGeneral surgical used , GEO-MED ORTHO TOTAL JOINT TRACECART® ,http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119554
mdprc 149 04 12 001Leica Microsystem inc Laboratory Instrument, ASP 6025 Vaccum Tissue ProcessorFDA
mdprc 103 07 13 000Zimmer incOrthopaedic , Bigliani/Flatow® The Complete Shoulder Solutionhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118471
mdprc 102 07 13 000Toshiba American Medical Systems IncX-ray , TOSHIBA Kalare Diagnostichttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117798
mdprc 101 07 13 000Medtronic MiniMedInsulin Infusion Sets , Medtronic MiniMed Paradigmhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118883
mdprc 100 07 13 000Fresenius Medical CareDialysis System , Freseniushttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118571
mdprc 098 07 13 000Baxter HealthcareIrrigation Set , Four Lead TUR Irrigation Set, UROMATIC Plastic Containers , Four Lead Arthroscopic irrigation Sethttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118153
mdprc 094 07 13 000Baxter Healthcare.Elastomeric infusion pumps , FOLFUSOR , INFUSORhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119649
mdprc 021 07 13 001GE HealthcareRadiographic Systems, GE Healthcare Senographe Essential SystemFDA
mdprc 072 05 12 001Zimmer incNexgen Complete Knee Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108582
mdprc 081 07 13 000Bryan Medical IncPediatric tracheostomy tube , Tracoe Mini 3.0mm Tubehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118949
mdprc 055 07 13 000SpineFrontier IncIntervertebral Body Fusion Device , S-LIFThttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118893
mdprc 054 07 13 000SpineFrontier IncInserter , InSpan Inserterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118935
mdprc 053 07 13 000SpineFrontier IncFixation , S-LIFT inserter outer sleevehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118885
mdprc 044 07 13 000Merit Medical Systems IncAngiography Kits, Custom Procedural TraysFDA
mdprc 042 07 13 000BRAEMAR, INC.Lithium Thionyl non-rechargeable disposable battery packFDA
mdprc 041 07 13 000BRAEMAR, INC.Lithium Thionyl non-rechargeable disposable battery packFDA
mdprc 040 07 13 000ConMed Linvatec CorporationSoft-tissue anchor, GENESYS Cross FT Suture Anchor with Two #2 (5 metric) HI-FI SuturesFDA
mdprc 039 07 13 000Clorox Healthcare Holdings, LLC (dba HealthLink)Punches, Biopsy, Skin, Disposable, Biopsy PunchesFDA
mdprc 038 07 13 000Surgical Instrument Service And Savings, Inc.Surgical instrument, Various productsFDA
mdprc 027 07 13 000Bard Access SystemsCatheter Tube Holders, StatLockFDA
mdprc 026 07 13 000GE HealthcareX-ray, GE Healthcare, Innova 3100 and Innova 4100 systemsFDA
mdprc 025 07 13 000Baxter HealthcareInfusion Pumps, Coiled Tube Infusor, Infusion PumpFDA
mdprc 024 07 13 000Terumo Medical CorporationCatheter accessories, Terumo Glidesheath and Pinnacle® Destination® Peripheral Guiding SheathFDA
mdprc 023 07 13 000RF Technologies, Inc.Fall Management Solutions, Code Alert, SensatecFDA
mdprc 022 07 13 000Steris CorpSterilization device accessories, Quick ConnectFDA
mdprc 020 07 13 000CynosureLasers, RevLite SI LaserFDA
mdprc 019 07 13 000ThermoFisher ScientificIncubators, Laboratory, Thermocycling, CO2 Incubators (General Purpose Incubator)FDA
mdprc 018 07 13 000Engineered Medical Systems,IncMasks, SealFlexFDA
mdprc 077 05 13 001Hologic IncImaging System, Fluoroscan Mini C-arm InSight2,FDA
mdprc 150 06 13 000Philips Healthcare X-ray, Philips Bucky DiagnostFDA
mdprc 149 06 13 000Philips HealthcareX-ray, Philips Bucky DiagnostFDA
mdprc 148 06 13 000Medtronic Sofamor Danek USA IncGrafts, Bone, INFUSE(R) Bone GraftFDA
mdprc 147 06 13 000Medrad IncMonitors, Physiologic, Vital Signs, DC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs MonitorFDA
mdprc 146 06 13 000Zimmer incSurgical Instruments, Drill, NEXGEN Complete Knee Solution Monoblock Tibial Drill with stop 10.7 mmFDA
mdprc 145 06 13 000GE HealthcareInformation system, Centricity Laboratory Core LabFDA
mdprc 129 06 13 000Prism Medical LtdLifts, Patient Transfer, C-Series Carry BarFDA
mdprc 128 06 13 000Terumo Cardiovascular Systems CorporationHeat Exchangers, Sarns " TCM II Temperature Control ModuleFDA
mdprc 127 06 13 000Microgenics CorpReagent, Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista SystemsFDA
mdprc 126 06 13 000Linde Gas North America LlcPortable Oxygen System, MEDICYCL-E- LiteFDA
mdprc 125 06 13 000Tecan USAutomation Systems, Laboratory, Freedom EVO 2 with TouchTools Suite Version 3.0FDA
mdprc 124 06 13 000Hitachi Medical CorpMR imaging device systems, Echelon, Echelon Oval and OasisFDA
mdprc 123 06 13 000Prism Medical LtdMesh Sling, BC HammockFDA
mdprc 122 06 13 000Ortho-Clinical DiagnosticsIVD, VITROS Clinical Chemistry Products Homocysteine (HCY) ReagentFDA
mdprc 120 06 13 000Biomet IncConnecting Bolt Trauma Fixation Systems, Phoenix Retrograde Femoral NailFDA
mdprc 019 04 12 001IDEV Technologies IncSUPERA VERITAS Interwoven Nitinol Stent Transhepatic Biliary Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107279
mdprc 114 06 13 000Zimmer incFrames, Traction, Zimmer Patient Helper Bed Frame Adapter AssemblyFDA
mdprc 113 06 13 000Ormco/SybronendoDental Hand Instruments, Endodontic, SybronEndo Elements Obturation Unit and SybronEndo Replacement AC Power Cord, US Elements ObturationFDA
mdprc 112 06 13 000Utah Medical Products, IncTransducers, Pressure, Disposable, Deltran KitFDA
mdprc 111 06 13 000Embla System LlcPolysomnography Recorder, Ventilator Effort Recorder, Embletta GoldFDA
mdprc 110 06 13 000Leica Microsystems, Inc.Storage device, LPC Fine Mesh CassettesFDA
mdprc 108 06 13 000Philips HealthcareRadiographic System , Philips Digital Diagnostichttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115400
mdprc 107 06 13 000Philips HealthcareRadiographic System , Philips Digital Diagnosthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115398
mdprc 106 06 13 000Biomet IncComprehensive reverse shoulder system , Superior Approach Resection Guide Assemblyhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=118271
mdprc 082 08 12 001Epocal IncReagents, epoc BGEM Test Cards Used with epoc Blood Analysis Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107399
mdprc 067 06 13 000Bard Pcripheral Vascular (BPV)Implantable, Catheter, Guiding, Vascular, BARD Biopsy Systems and support catheters (Microsheath and Usher)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115745
mdprc 065 06 13 000Endologix IncCatheter, Introducer, AFX Introducer SystemFDA
mdprc 064 06 13 000Invatec SpACatheter, lnvatec SpA brand Diver C.EFDA
mdprc 063 06 13 000Bard Pcripheral Vascular (BPV)Markers, Implantable Radiographic, UltraClip Dual Trigger breast tissue markerFDA
mdprc 062 06 13 000FenwalApheresis Unit, AMICUS Exchange KitFDA
mdprc 061 06 13 000American Optisurgical Inc Handpieces, Surgical, TX1 Tissue Removal SystemFDA
mdprc 060 06 13 000Cordis CorporationStents, Vascular, Peripheral, Self-Expanding, FLEXSTENTFDA
mdprc 092 03 13 001Symbios Medical ProductsElastometric infusion PumpKithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116110
mdprc 050 06 13 000SpineFrontier IncSurgical instruments, implant impactor, Dorado Straight ImpactorFDA
mdprc 049 06 13 000Kreg Medical Inc.Beds, Electric, EZ Wider Bariatric BedFDA
mdprc 048 06 13 000Stryker InstrumentsGowns, Medical, Hytrel TogaFDA
mdprc 047 06 13 000Coloplast A/SSuture, Digitex 2-0 Polydioxanone (PDO) sutureFDA
mdprc 046 06 13 000Biomet IncProstheses, Joint, Hip, E1 Advantage HeadFDA
mdprc 045 06 13 000Zimmer Surgical IncDermatomes, Manual, Air DermatomeFDA
mdprc 044 06 13 000Hill Rom IncBeds, Electric, Hill-Rom 1000 BedFDA
mdprc 043 06 13 000Hill Rom IncLifts, Patient Transfer, SlingBarFDA
mdprc 042 06 13 000HORIBA ABX DiagnosticsIVD, measure absorbance and ion electrodes, ABX PENTRA 400 I.S.E. ModuleFDA
mdprc 024 06 13 000Maytex CorpMask, Comfort Ear-Loop Face MaskFDA
mdprc 023 06 13 000GE HealthcareVarious Anesthesia Machines, Aespire, Aespire View, Avance, Avance CS2, Aisys, ADU, 9100, M900, M904, 9300 systemsFDA
mdprc 022 06 13 000I-FlowInfusion Pump Administration Sets, I-Flow ON-Q Pain Relief SystemFDA
mdprc 021 06 13 000Gyrus ACMIKnife, Blade, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLEFDA
mdprc 020 06 13 000Heart Sync, IncRadiotransparent Defibrillation Electrodes Monophasic or biphasic compatible defibrillation/cardioversion/pacing/ECG Monitoring electrodes, Vermed, Inc & Heart Sync C100-Physio Radiotransparent Defibrillation ElectrodesFDA
mdprc 019 06 13 000TZ Medical Inc.Adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes, Medtronic/Physio Control Transparent Defibrillation ElectrodesFDA
mdprc 015 06 13 000Fisher & Paykel Healthcare IncTherapeutic positive pressure breathing ventilator, Fisher & Paykel Healthcare ICON CPAPFDA
mdprc 014 06 13 000Intuitive Surgical IncTelemanipulation Systems, Surgical, Minimally Invasive, daVinci TORSFDA
mdprc 108 05 13 000Separation Technology, IncSLIDERPREP PLUS SLIDE PREPARATION CENTRIFUGEFDA
mdprc 107 05 13 000Polymer Technology Systems, Inc.IVD,CardioChek PTS Panels Glucose Test StripsFDA
mdprc 097 05 13 000Unimed Surgical Products, IncPROGRESSIVE MEDICAL Laparoscopic Electrode PTFE Coated L Hook 33cmFDA
mdprc 096 05 13 000 Technidata SASLaboratory Information System, TD-SynergyFDA
mdprc 095 05 13 000Stryker Howmedica Osteonics CorpTriathlon Femoral Distal Augment- LeftFDA
mdprc 094 05 13 000Molift ABLift and transport a patient, Molift Smart 150FDA
mdprc 093 05 13 000Depuy OrthopaedicsPinnacle Hip Solutions ALTRX Polyethylene Acetabular LinerFDA
mdprc 092 05 13 000Chicago X-Ray Systems, Incx-ray system, Fona Srl IntraOs 70 intra-oral x-ray systemFDA
mdprc 091 05 13 000CEFLA DENTAL GROUPMyRay RXDC dental unit x-ray unitFDA
mdprc 081 05 13 000Philips Medical SystemsComputed Tomography X-ray systems, Brilliance CT 16-Slice WaterFDA
mdprc 080 05 13 000Varian Medical SystemsPulsed Dose Rate, Segmented Cylinder Applicator SetFDA
mdprc 079 05 13 000MEDTOX Scientific IncIVD Test Reagent/Kits, Immunoassay, PROFILE-V MEDTOXScan Test DevicesFDA
mdprc 078 05 13 000IRIS DiagnosticsIVD, Iris Diagnostics Division iQ Control/FocusFDA
mdprc 063 05 13 000QIAGEN LtdReagent, Qiagen artus CMV RG PCR ASRFDA
mdprc 062 05 13 000GE HealthcareRadiographic/Fluoroscopic Systems, General-Purpose, GE Healthcare Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ, Innova 2121 IQ, Innova 3131 IQ , InnovFDA
mdprc 061 05 13 000Edwards LifesciencesProcedure Kit/Trays, Cardioplegia Solution Administration, Proplege Coronary Sinus CatheterFDA
mdprc 060 05 13 000ConMed CorporationElectrodes, Defibrillation/Pacing, PadPro(R) Adult Radiotransparent Multifunction ElectrodesFDA
mdprc 050 05 13 000Integra LifeSciences CorporationBiological, Collagen, Absorbable, Many products manufactured by Integra LifeSciences CorporationFDA
mdprc 049 05 13 000Karl Storz Endoscopy America IncResectoscope accessories, Karl Storz Electrode, Cutting Loops and Cold KnivesFDA
mdprc 048 05 13 000bioMerieux IncIVD, PREVI Isola SystemFDA
mdprc 044 05 13 000Insight Instruments IncMulti-Port Illumination System, Insight Instruments MISFDA
mdprc 042 05 13 000OlympusElectrosurgical Units, Olympus SurgMaster UES-40 electrosurgical unit ("UES-40")FDA
mdprc 041 05 13 000Karl Storz Endoscopy America IncTelescope, Camera Head, Camera System, Karl Storz Photodynamic Diagnosis (PDD) D-Light C SystemFDA
mdprc 030 05 13 000Baxter HealthcareProcedure Kit/Trays, Catheterization, Peritoneal, Dialysis, Non-DEHP Catheter Extension SetFDA
mdprc 029 05 13 000BD BiosciencesReagents, Molecular Assay, BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent PackFDA
mdprc 028 05 13 000Cardinal HealthProcedure Kit, Various Presource KitsFDA
mdprc 027 05 13 000Synthes IncProstheses, Joint, Elbow, Synthes Radial Head Prosthesis: Trial Radial HeadFDA
mdprc 018 05 13 000Stryker EndoscopySuction Tips, Stryker Irrigator Reusable TipsFDA
mdprc 017 05 13 000Owens & MinorAbsorbent tipped applicator, sterile, Antiseptic swab, Cotton bud, MediChoice® Rayon Tipped OB/GYN ApplicatorFDA
mdprc 016 05 13 000NxStage Medical, Inc.Dialysate, Hemodialysis, NxStage PureFlow-B SolutionFDA
mdprc 002 05 13 000Roche Diagnostics Corpcobas® 8000 modular analyzer series ,Rapid PCR analyzer ,AMPLILINK ,The MagNA Pure 96 System ,DataCare POCFDA
mdprc 125 04 12 001Integra LifeSciences CorporationProsthesis Implantation, Screws, Panta Arthrodesis NailFDA
mdprc 150 04 13 000GE HealthcareX-ray transmission, Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117278
mdprc 135 04 13 000Carestream Health Inc Div Onex CorpKODAK INSIGHT DENTAL FILM in SureSoft Packetshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115408
mdprc 127 02 13 001Greiner Bio-One IncBlood Collection Needle Sets, 23 x 12-Inch Safety Blood Collection Sets with Luer Adapterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115829
mdprc 124 04 13 000Spinal Solutions LLCAPLIF Implants and Instruments, The Eminent Spine Interbody Fusion Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116518
mdprc 123 04 13 000Newport Medical Instruments IncVentilators, HT70 and HT70 Plus ventilatorshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117179
mdprc 104 04 13 000Transonic Systems IncAV Loop Kit For use with Transonic CO status System Only.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117016
mdprc 103 04 13 000Heritage Labs InternationalIVD, Study Extra Supplies Kithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117176
mdprc 102 04 13 000Advanced Sterilization ProductsEVOTECH Endoscope Cleaner and Reprocessor Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117051
mdprc 086 04 13 000Acist Medical SystemsInjectors, Contrast Media, Angiography, Model BT2000 Automated Manifold Kitshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117164
mdprc 085 04 13 000Nipro CorpBlood Glucose System, Duane Reade TRUEtrack monitor kithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116357
mdprc 084 04 13 000GE HealthcareCardiovascular and Interventional Imaging System, Innova 2100IQ, Innova 3100IQ, Innova 4100IQhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117259
mdprc 083 04 13 000Accuray IncRoboCouch Patient Positioning System , support and positioning of a patient during radiosurgery.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=117112
mdprc 082 04 13 000Terumo Cardiovascular Systems CorporationHematocrit/Oxygen Saturation Monitoring Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106244
mdprc 068 04 13 000Instrumentation Industries IncVentilators , Manual Jet VentilatorsFDA
mdprc 067 04 13 000Roche Diagnostics CorpIVD , Accu-CheK Inform II Blood Glucose Monitor and barcaode scannerFDA
mdprc 066 04 13 000Siemens Healthcare DiagnosticsIVDs, clinical chemistry instrumentation, ADVIA Centaur Vitamin D AssayFDA
mdprc 065 04 13 000Synvasive Technology IncCutting ,surgical tool , SynvasiveFDA
mdprc 064 04 13 000GE HealthcareMuse v7 cardiology information systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116925
mdprc 063 04 13 000Synvasive Technology IncSurgical Saw Bladehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116702
mdprc 062 04 13 000Smith & Nephew incTRIGEN (TM) L-P SCREW, orthopedic surgeryhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116740
mdprc 061 04 13 000Philips HealthcareComputed Tomography X-Ray Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116837
mdprc 060 04 13 000Endogastric Solutions IncEsophyX2 Plus Device , Endoscope Clip applierhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116023
mdprc 059 04 13 000DeGotzenDental X-rayhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116879
mdprc 058 04 13 000Bacterin International, IncOsteoSelect DBM Putty , Orthopedic bone fillerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116258
mdprc 049 04 13 001Ortho-Clinical DiagnosticsClinical chemistry instrumentation. VITROS 4600 Chemistry SystemFDA
mdprc 053 04 13 000Toshiba Corp Medical Systems Co LtdX-Ray, Tomography, Computed, ToshibaTSX-30IC AQUILION ONE SystemFDA
mdprc 052 04 13 000US EndoscopyIrrigation tube , Torrent irrigation systemFDA
mdprc 051 04 13 000Integra LifeSciences CorporationRadiosurgery and Radiotherapy Treatment Planning , Integra XKnife® StereotacticFDA
mdprc 050 04 13 000Edwards LifesciencesCannula , Vascular, Perfusion , Fem-Flex II Femoral Arterial CannulaFDA
mdprc 048 04 13 000Synthes IncNails, Bone, Synthes Flexible GripFDA
mdprc 047 04 13 000LeMaitre Vascular GmbHMarkers, Implantable Radiographic, VascuTape Radiopaque Tape, LeMaitre Stent GuideFDA
mdprc 046 04 13 000Cooper Surgical, Inc.Procedure Trays, Surgical, LEEPFDA
mdprc 045 04 13 000Medtronic NeuromodulationRadiofrequency Therapy Systems, Tissue Ablation, Prostatic, ProstivaFDA
mdprc 020 04 13 000Philips Medical SystemsX-RAY, TF PET/CT , imaging systemFDA
mdprc 019 04 13 000Beckman Coulter IncIVD, Access Immunoassay SystemFDA
mdprc 018 04 13 000Zimmer incRetractor access system, NexPosure Portal System, placement of posterior spinal fixation implants.FDA
mdprc 017 04 13 000Integra LifeSciences CorporationIntraoperative cortical stimulation , Ojemann Cortical StimulatorFDA
mdprc 091 03 13 001Smith & Nephew incINTERNAL HEX RECON SCREW, Orthopedichttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115887
mdprc 012 04 13 000Synthes USA (HQ) Inc.Dens Instrument Set (Dens Graphic Case), Anterior Column Retractor Set,fractures bonehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115737
mdprc 011 04 13 000Microbiologics IncIVD, KWIK-QC Acid Fast Stain Slides and KWIK-QC Mycobacterium Slideshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116205
mdprc 010 04 13 000COOPER SURGICAL INC.Omniflex Diaphragm , contraceptive devicehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116371
mdprc 009 04 13 000Zyno Medical LLCZ-800 Volumetric Infusion Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116161
mdprc 008 04 13 000Smiths Medical ASD Inc9004 Capnocheck® Capnography , PULSE OXIMETERShttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116450
mdprc 004 04 13 000Gen-Probe IncorporatedIVD Test Reagent/Kits, Immunoassay, Immunology, LIFECODES PF4 Enhanced Assay Reagentshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116359
mdprc 003 04 13 000CareFusion CorpPyxis Anesthesia Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=86996
mdprc 002 04 13 000Cardinal HealthNeedle, Sterile Needle Countershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115143
mdprc 147 03 13 000Smiths MedicalMedfusion Model 3500 Syringe Pumphttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114372
mdprc 146 03 13 000Kimberly Clark Health CareSterilization Packaging, KIMGUARD Container Filtershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116773
mdprc 136 03 13 000Toshiba Corp Medical Systems Co LtdToshiba Infinix-i X-Ray System, A radiographic and fluoroscopichttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116745
mdprc 133 03 13 000Intio IncClearStart-SVM" , semi-automated tools for segmentationhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116141
mdprc 132 03 13 000Spacelabs Healthcare IncBleaseFocus Anesthesia Workstationhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116425
mdprc 131 03 13 000Mindray DS USA, Inc.IVD, BS-200 Chemistry Analyzerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115382
mdprc 130 03 13 000Keystone Dental IncImplant, PrimaConnex Tapered Implant TChttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116685
mdprc 124 03 13 000AGFA Corp.CR 10-X, x-ray imager image platehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116405
mdprc 112 03 13 000Stryker Howmedica Osteonics CorpOrthopaedics , Triathlon Left and Righthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116175
mdprc 111 03 13 000Molded Products IncSterile Access & Return Line Set, hemodialysis blood tubinghttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116207
mdprc 110 03 13 000Alphatec Spine IncOsteosynthesis, bone screws, IILICO MIS Posterior Spinal Fixation Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=90188
mdprc 109 03 13 000Allen Medical SystemsAnkle Traction Boot, Orthopedic Leg Holdershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116368
mdprc 097 03 13 000Synthes USA (HQ) Inc.Variable Angle Locking Compression Plate, Variable Angle LCP Dorsal Distal Radius Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115544
mdprc 096 03 13 000Hill Rom IncTotalCare SpO2RT2 bed, flotation therapyhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116540
mdprc 095 03 13 000ExactechThe Optetrak Logic Comprehensive Knee Systems, Proximal Tibial Spacerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116190
mdprc 094 03 13 000Ebi, LlcScrew fixation system, Biomet Spine Polaris 5.5 Button Lock Screw Inserterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116169
mdprc 093 03 13 000Beckman Coulter IncIVD, Creatinine,System reagent , AU analyzers.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115469
mdprc 090 03 13 000Natus Medical IncNicolet EEG Wireless Amplifier ,electrophysiological signalshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116224
mdprc 089 03 13 000Philips Medical Systems Computed Tomography, X-Ray Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116035
mdprc 087 03 13 000Bacterin International, IncHubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless,surgical wound drainage.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115836
mdprc 025 02 13 001Ormco CorpLightspeed LSXhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115470
mdprc 067 03 13 000Synthes IncX Pedicle Screw , stabilization of the spinehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115816
mdprc 066 03 13 000Synthes IncLarge Combination Clamp/Large External Fixation System, bone and pelvic fractureshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115818
mdprc 065 03 13 000GE HealthcareInnova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ, Cardiovascular X-ray imaging systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115743
mdprc 062 03 13 000Keystone Dental IncStraight Esthetic 5.0 mm 3. mm ,Cuff Abutment ,surgical, bonehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116219
mdprc 061 03 13 000Innominata Dba GenbioIVD, MICROPLATE EIA Kit,ANTI-BORRELIA (LYME)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115898
mdprc 060 03 13 000Elekta IncSynergy XVI, Digital Imager, Radiation Therapyhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115474
mdprc 059 03 13 000Stryker Osteosynthesis Intramedullary SolutionsMeasure the height of the disc space intra-operatively, Stryker AVS Navigatorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108786
mdprc 058 03 13 000Medtronic Navigation IncO-arm Imaging System ,fluoroscopic x-rayhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115675
mdprc 057 03 13 000Genesys Orthopedic SystemsCervical Screws, 3.75mm x 12mm , Spine Anterior Cervicalhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116108
mdprc 056 03 13 000Biomet IncStraight Acetabular Inserter Handle , surgical,bonehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115921
mdprc 053 03 13 000Churchill Medical A Vygon CoLifeguard Infusion Set with Smartsitehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116188
mdprc 052 03 13 000Bard Access SystemsCatheters, Vascular, Infusion, Central Venous, Hickman and Leonard Dual-Lumen Catheter Kitshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116113
mdprc 051 03 13 000AtriCure IncThe Isolator Transpolar Pen ,ablate cardiac tissueshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116050
mdprc 082 02 12 001Siemens Medical SolutionsTherapeutic treatment of cancer, ARTISTE and ONCOR linear acceleratorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105696
mdprc 031 03 13 000Synthes IncDistractors, Various Multiaxial Manual Multi-Vector Distractorshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116033
mdprc 025 03 13 000Salyer Prn BiomedicalCentury Console Base,use as a platform ,for other ancillary equipment and disposable products in cardiopulmonary surgical procedureshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115964
mdprc 024 03 13 000Philips HealthcareIMAGING ,Stationary radiographic systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114455
mdprc 023 03 13 000GE Healthcare Volume Viewer Plus, Volume Analysis, Advantage Workstationhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115318
mdprc 022 03 13 000Philips Medical SystemsCT Scanner System ,The MX 16-Slice , X-ray systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115986
mdprc 021 03 13 000Myco Medical Suppliescutting device,Technocut Plus,Scalpel,surgicalhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116137
mdprc 020 03 13 000GE HealthcareX-Ray System , Definium 5000http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115405
mdprc 006 03 13 000Oculus Innovative Sciences IncGel burn,Atrapro Antipruritic Hydrogel, 1.5 oz gel tubehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115812
mdprc 005 03 13 000AesculapBipolar Coagulator ,use in surgeryhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116053
mdprc 199 02 13 000Integra LifeSciences CorporationElectrosurgical Units, Monopolar, Jarit Monopolar Cables Used with Jarit Endoscopic Instrumentshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115922
mdprc 198 02 13 000GE HealthcareX-Ray System / Brivo XR385 DR-Fhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115627
mdprc 174 02 13 000Mc-NEIL-PPC, IncKY® TINGLING® JELLY Personal Lubricant,Vaginal Moisturizerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110244
mdprc 173 02 13 000Intel-GE Care Innovations LLCThe QuietCare systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115109
mdprc 172 02 13 000Integra LifeSciences CorporationBase Unit Standardhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115508
mdprc 171 02 13 000Hill Rom IncOverhead Rail Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110244
mdprc 170 02 13 000Bayer Healthcare LLCAngiography Kits, Medrad Hand Controller Sheathshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115839
mdprc 169 02 13 000Stryker Sustainability SolutionsRestep DVT Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114588
mdprc 168 02 13 000Merit Medical Systems IncThe Resolve Biliary Locking Drainage Catheterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115545
mdprc 167 02 13 000Ansell Healthcare Products LLCLifeStyles ZERO 10 uber-thin lubricated latex condomshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115660
mdprc 134 02 13 000HealthTronics IncEndocare 3.8mm RenalCryo Cryoprobehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115069
mdprc 128 02 13 000Lockheed Martincamera systems ,Laser pointer and illuminatorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115239
mdprc 126 02 13 000GE HealthcareMonitor,CARESCAPE Monitor B650http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115653
mdprc 125 02 13 000GE HealthcareDash Port 2 Docking Station,monitorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114428
mdprc 123 02 13 000Depuy Orthopaedics, IncLPS Diaphyseal Sleeveshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114764
mdprc 117 02 13 000Fresenius Medical CarePeritoneal Dialysis Sterile Connection Units, LIBERTY Automated Peritoneal Dialysis System Line Cycler Setshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115494
mdprc 114 02 13 000GE HealthcareThe Dash 3000/4000/5000 ,patient monitorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114419
mdprc 113 02 13 000Mizuho OSIOrthopedic Systems, The tablehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115181
mdprc 112 02 13 000Breg Inc, An Orthofix CompanyPads, Circulating-Fluid, Sterile Polar Pads Contained in Cold Therapy Combination Unitshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115498
mdprc 111 02 13 000AesculapMiethke Shunt Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113098
mdprc 089 02 13 000ExactechProstheses, Joint, Hip, Novation Crown Cup Connection GXL Neutral Linershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115319
mdprc 088 02 13 001Custom Healthcare SystemSterile medical device containing multiple components to perform a breast biopsy , Breast Biopsy Trayhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115337
mdprc 087 02 13 000Bacterin International, IncBone void filler for voids or gaps in bone. Indicated for treatment of surgically created osseous defects , http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113766
mdprc 054 09 12 001Linvatec Corp.Bone Punch, PopLok Punchhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111312
mdprc 071 02 13 000Westone Laboratories, IncPatient lubricant, OTO EASEhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110825
mdprc 058 02 13 000Winco, Inc.Chair, Reclinerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114733
mdprc 057 02 13 000The Anspach Effort, Inc.Bearing Sleeve with Removable Bur Guardhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114783
mdprc 056 02 13 000Lansinoh LaboratoriesTHERA PEARL 3-in-1 BREAST THERAPYhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115101
mdprc 055 02 13 000Invacare CorporationSolara 3G Custom Manual Wheelchair Z-0785-2013
mdprc 028 02 13 000Tobii Technology ABP10 Tobii battery packhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115353
mdprc 011 02 13 000Motorola IncPCS3000/CS3070 Laserhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109265
mdprc 010 02 13 000Moog IncInfinity Enteral Feeding infusion pumphttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113975
mdprc 009 02 13 000Hamilton Medical IncHAMILTON-T1 Ventilatorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115383
mdprc 008 02 13 000GE HealthcareAdvantageSim MDhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108534
mdprc 007 02 13 000Extremity MedicalProsthesis Implantation Instruments, Orthopedic, IO FiX Screw Measuring Deviceshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114794
mdprc 005 02 13 000Biomet IncScrews, Bone, TunneLoc Round Head Interference Screwshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115199
mdprc 130 01 13 000Philips Medical SystemsJuno DRF , X-ray system, diagnostic, Fluoroscopichttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114934
mdprc 129 01 13 000Alfa Wassermann, Inc.Alfa Wassermann System Diluent 750 mL ,water solutionhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114930
mdprc 115 01 13 000Mindray DS USA, Inc.DPM5 Monitorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114790
mdprc 109 01 13 000Medisystems CorpButtonhole Needle Sethttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115204
mdprc 108 01 13 000Cordis CorporationClips, Surgical, Wound Closure, ExoSeal Vascular Closure Deviceshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114845
mdprc 107 01 13 000BioMerieux IncBacT/ALERT SA Blood Culture Bottlehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115293
mdprc 106 01 13 000DePuy Spine, Inc.Spine VIPER POLY SCREW 5.5 8 X80MMhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114495
mdprc 105 01 13 000Becton Dickinson & Co. (BD)Analyzers, Laboratory, Molecular Assayhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115099
mdprc 078 01 13 000Vycor MedicalViewsite Brain Access System (VBAS)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113513
mdprc 077 01 13 000Immunodiagnostic Systems LimitedThe IDS 25-Hydroxy Vitamin D EIA kithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114873
mdprc 076 01 13 000Becton Dickinson & Co. (BD)BBL Crystal Enteric/Nonfermenter ID Kithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115111
mdprc 072 01 13 000Sunquest Information Systems IncSunquest Laboratoryhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113605
mdprc 071 01 13 000Sunquest Information Systems IncSunquest Application Interfacing Outbound Phlebotomy Point of Care Interfacehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113627
mdprc 070 01 13 000Radiometer Medical automated analyzer, ABL80 FLEX CO-OX analyzerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113592
mdprc 069 01 13 000OrthoPediatrics CorpNails, Bone, Trochar Scalpel Instrumentshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113679
mdprc 068 01 13 000Spacelabs Healthcare IncPatient health record,information system, Intesys Clinical Suite (ICS) G2 Smart Disclosurehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115067
mdprc 067 01 13 000Quanta SystemEterna Giovinezza System,Ultrawave II EX 1320/ Ultrawave III EX 1320 ,Q-Plus T,Powered Laser Surgical Instrumenthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115258
mdprc 066 01 13 000Philips Medical SystemsComputed Tomography X-Rayhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114728
mdprc 055 01 13 000Philips Medical SystemsCT Computed Tomography ,Brilliance 64 and Ingenuityhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114827
mdprc 083 08 12 001GE Medical SystemsImage-intensified fluoroscopic x-ray system, OEC 8800 Flexview and OEC 6800 Miniviewhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110394
mdprc 045 01 13 000Terumo Cardiovascular Systems CorporationAortic Arch Cannula and Sarnshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115298
mdprc 044 01 13 000Siemens Healthcare DiagnosticsEmit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL).http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114962
mdprc 042 01 13 000Merit Medical Systems IncProcedural Trayhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113073
mdprc 027 01 13 000MAQUET Cardiovascular LLCCARDIOSAVE Intra-Aortic Balloon Pumphttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109877
mdprc 026 01 13 000Concentric Medical IncFlowGate Balloon Guide Catheterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=115074
mdprc 024 01 13 000Surgical Tissue Network IncUltraFill DBM,Donated Human Tissue Allografthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113638
mdprc 023 01 13 000California Medical Laboratories IncSuction Kits, Standard Rigid Tip Suction Wandshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114967
mdprc 022 01 13 000Applied Medical ResourcesKii Shielded Bladed Access System,Laparoscopehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114879
mdprc 021 01 13 000Philips Medical SystemsDefibrillator,HeartStart FRx 861304 , Laerdal brands of HeartStart HS1http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112328
mdprc 020 01 13 000Stryker MedicalMedical Surgical Bedhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114351
mdprc 019 01 13 000Mindray DS USA, IncDPM Central Stationhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114367
mdprc 018 01 13 000HORIBA ABX DiagnosticsThe Pentra C200 systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114865
mdprc 017 01 13 000Fisher & Paykel Healthcare Inc900MR068Reusable breathing circuithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114789
mdprc 013 01 13 000B Braun Medical IncSpace Pump Pole Clampshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114927
mdprc 011 01 13 000Terumo Cardiovascular Systems CorporationTerumo Backplate Replacement CXFVR 1500 Holderhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113066
mdprc 010 01 13 000GE HealthcareMobile X-ray system, innovahttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112315
mdprc 007 01 13 000Medtronic IncHeart-Lung Bypass Unit Tubing Sets, Intersept Tubing Packshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114738
mdprc 006 01 13 000GE HealthcareGiraffe and Panda Warmer T-Piece Resuscitation Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112681
mdprc 005 01 13 000Brookstone CompanyBrookstone Heated Body Beanhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114063
mdprc 003 01 13 000Arjo IncFlowtron Trio DVT Pumphttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114918
mdprc 002 01 13 000Osteotech IncGrafts, Bone, Various Grafton Bone Graft Materialshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112940
mdprc 001 01 13 000MOOG Medical Devices GroupInfusion Pumps, Ambulatory, Moog Ambulatory Administration Sets Used with Moog Curlin Ambulatory Pumpshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113568
mdprc 162 12 12 000Teleflex MedicalLigating Clips, Hem-o-lok Large Polymer Ligating Clipshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113590
mdprc 161 12 12 000GE HealthcareMammography systems, Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108524
mdprc 160 12 12 000AesculapColumbus 4-IN-1 Femoral Cutting Guide M3 Instrumenthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113061
mdprc 159 12 12 000Sanofi-AventisDiamigo i-Phone Apphttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114792
mdprc 158 12 12 000Varian Medical SystemsBrachytherapy Applicator, Segmented Cervix Applicator Set, Guide tube for segments and cervical sleeveshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114525
mdprc 157 12 12 000Praxair IncOX-M-AEGNGVNTG,Praxair Vantage ,Cylinder pressure regulatorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114654
mdprc 156 12 12 000Philips Medical SystemsComputed Tomography X-Rayhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114188
mdprc 155 12 12 000Depuy Orthopaedics, IncSOLUTION System Calcar Stems ,SOL SYS L 9IN CALC 2.25/15.0http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114637
mdprc 154 12 12 000BioMotion Medical Systems, LLCBioMotion Spinal Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114771
mdprc 153 12 12 000Spacelabs Healthcare IncBleaseFocus Anesthesia Workstation and 700/900 Series Ventilatorshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114600
mdprc 152 12 12 000GE HealthcareAdvantage Workstation Volume Share 2http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108512
mdprc 151 12 12 000Integra LifeSciences CorporationMAYFIELD Composite Series Skull Clampshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114755
mdprc 150 12 12 000Becton Dickinson & Co. (BD)BD Phoenix PMIC-108 Panelshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114682
mdprc 144 12 12 000Stryker MedicalStretchers, Mobile, Ambulance, Model 6390 Power-LOAD Ambulance Cot Fastener Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114920
mdprc 143 12 12 000Medline Industries IncMedline Angio Drape Pack Radiology-LFhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114684
mdprc 142 12 12 000Depuy Orthopaedics, IncPinnacle Cancellous Screwhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111672
mdprc 141 12 12 000Zimmer incCoonrad/Morrey New Ulnar Revision Kithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114543
mdprc 140 12 12 000Zimmer incThe Personalized Knee Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114661
mdprc 139 12 12 000Invacare Corporation.Canes, Adjustable-Length, Offset-Handle, Offset and Standard Crook Caneshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114753
mdprc 138 12 12 000Varian Medical SystemsARIA Oncology Information System Radiation Oncologyhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114598
mdprc 135 12 12 000TITAN SPINESpine Endoskeleton TA Implanthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114191
mdprc 132 12 12 000Mindray DS USA, Inc., dba Datascope Patient MonitoringThe V Series Monitor , Patient Monitorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114418
mdprc 130 12 12 000Medline Industries IncKnee CDShttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114135
mdprc 128 12 12 000EEG InfoEEG NeuroAmphttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114838
mdprc 125 12 12 000Depuy MitekSterile Reamershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114672
mdprc 123 12 12 000Arobella Medical LLCAR1000 Qoustic Qurette,Wound Therapy Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114801
mdprc 115 12 12 000Sysmex America IncIVD, Sysmex XE-2100C, Sysmex XE-2100 and Sysmex XE-5000 automated hematology analyzerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113587
mdprc 114 12 12 000Sechrist Industries IncSechrist Monoplace Hyperbaric Chamber with Electronic Control Modulehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=84025
mdprc 113 12 12 000GE HealthcareCarescape Patient Data Module v2.0,http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114421
mdprc 112 12 12 000GE HealthcareThe Dash 3000/4000/5000 ,patient monitorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114415
mdprc 111 12 12 000Bunnell IncBreathing Circuits, Ventilator, Disposable Patient Circuitshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114595
mdprc 110 12 12 000Becton Dickinson & Co. (BD)BD BBL Taxo XV Factor Stripshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114627
mdprc 109 12 12 000Zimmer incProstheses, Joint, Hip, Femoral Component, CPT Modular Stemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112643
mdprc 108 12 12 000Linvatec Corp.Orthopedic surgical procedures,http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112590
mdprc 107 12 12 000Beckman Coulter IncIVD, UniCel Closed Tube Aliquotter for UniCel DxC 660i, 680i, 860i and 880i Synchron Access Clinical Syshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112909
mdprc 106 12 12 000Quasar Bio-TechAn infrared LED lamphttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114151
mdprc 086 12 12 001Siemens Healthcare DiagnosticsIVD Test Reagent/Kits, Emit(R) 2000 Phenobarbital Assay and Syva(R) Emit(R) Phenobarbital Assay http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111800
mdprc 089 12 12 000Ventlab CorpResuscitators, Various Manual Resuscitatorshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114235
mdprc 088 12 12 000Siemens Healthcare DiagnosticsIVD Test Reagent/Kits, Clinical Chemistry, Trace Metal, Iron, Dimension Vista System IRON Flex Reagent Cartridgeshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113760
mdprc 087 12 12 000Winco, Inc.Chairs, Examination/Treatment, Caremor Cliner Recliner Chairshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112495
mdprc 085 12 12 000Remington MedicalNeedles, Biopsy, Soft Tissue Biopsy Needleshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112454
mdprc 084 12 12 000OrthoHelix Surgical Design IncScrew, Mini MaxTorque Screw Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=89070
mdprc 083 12 12 000Kardium IncTORQ Sternal Closure Device, TWISTER, WIREhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112575
mdprc 082 12 12 000Immunodiagnostic Systems LimitedIVD, IDS-Isys Multi-Discipline Automated Analyserhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112212
mdprc 081 12 12 000Alere San DiegoFluorescence immunoassay, Triage TOX Drug Screen Panelhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112805
mdprc 080 12 12 0003M Health Care LtdSterilizing Units, Germicidal Gas, Ethylene Oxide, Steri-Vac Sterilizer/Aeratorshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113036
mdprc 079 12 12 000Philips HealthcareThe Information Center Software ,Philips IntelliVuehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114593
mdprc 078 12 12 000Parks MedicalCardiovascular blood flowmeterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113079
mdprc 077 12 12 000Covidien Electrodeshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107563
mdprc 076 12 12 000ConMed CorporationWANG Transbronchial Aspiration Needleshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114678
mdprc 075 12 12 000Terumo Cardiovascular Systems CorporationCentrifugal System, cardiopulmonary bypass, Sarns"FDA
mdprc 074 12 12 000Siemens Medical SolutionsRadiological image processing system, syngo.plazaFDA
mdprc 073 12 12 000ICU Medical, IncWaste system, 3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePodFDA
mdprc 057 12 12 000Synthes USA (HQ) Inc.Treatment of proximal humerus fractures, 4.5mm TI Multiloc Screw Lengthhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110178
mdprc 056 12 12 000Philips HealthcareDigital Diagnost ,X-ray systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114371
mdprc 055 12 12 000Neusoft Medical SystemsCT Scanner System and NeuViz Dual series CT Scanner Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114197
mdprc 054 12 12 000iwalk incLi-Ion Rechargeable Batteries and Battery Chargershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=11441
mdprc 053 12 12 000Biomet IncOSS Reamer Sleevehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114363
mdprc 048 12 12 000Terumo Cardiovascular Systems CorporationSoft Flow Aortic Cannulaehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113708
mdprc 047 12 12 000Stryker InstrumentsNeptune 2 Rover -Ultra , Max Vacuumhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114391
mdprc 046 12 12 000Siemens Medical SolutionsSyngo.plaza ,Radiological Image Processing Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114137
mdprc 045 12 12 000Sekisui DiagnosticsSekisui Diagnostics, Spectrolysehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114366
mdprc 044 12 12 000OmniGuide IncBP-ROBOTIC The OmniGuide Fiberhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114404
mdprc 043 12 12 000Merit Medical Systems IncCustom Procedural Trayshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111628
mdprc 041 12 12 000Natus Medical IncOlympic Cool-Cap system, a selective head cooling system for treatment of hypoxic-ischemic encephalopathy (HIE) in infants.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109204
mdprc 040 12 12 000Medtronic Navigation IncDrill Guide,used with a Medtronic Computer Assisted Surgery System to help assist with screw placement during spine surgical procedures.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114623
mdprc 039 12 12 000Kimberly Clark Health CarePatient Warming Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114416
mdprc 037 12 12 000IRadimed CorpInfusion Pump, Mridium Series 1000, Infusion Sets.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114544
mdprc 036 12 12 000GE HealthcareMobile X-ray Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113027
mdprc 004 12 12 000Zimmer incKnee prostheses, NexGen CompleteKnee Solutionhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114183
mdprc 003 12 12 000Terumo Cardiovascular Systems CorporationAdvanced Perfusion System Platform (APS)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114179
mdprc 002 12 12 000Cooper Surgical IncCannulae, Intrauterine, Arch Style Uterine Manipulation System Handleshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114523
mdprc 001 12 12 000Biomet IncOrthopedic Implant, Echo Bi-Metric Press-Fit Stems/Echo Bi-Metric 11mm x 135mm Collarless Porous Stem http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114596
mdprc 139 11 12 000Zimmer incProstheses, Trilogy Acetabular System Shell Prostheses with Cluster Holes.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114176
mdprc 138 11 12 000SpineFrontier IncFixation system, Spine Frontier Inspan compressors.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112677
mdprc 137 11 12 000SpineFrontier IncSurgical Guides, S-Lift Implant Guides.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112475
mdprc 136 11 12 000OrthoPediatrics CorpExtension osteotomy bone plate system, PLEO Osteotomy Guidehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114199
mdprc 135 11 12 000King Systems Corp.Laryngeal Airway Devices, KING LAD Silicone Flexible ClearSeal Single use.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114250
mdprc 134 11 12 000Captiva Spine, IncSpinal fixation, CapLOX II Pedicle Screw spinal System.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114524
mdprc 133 11 12 000Biomet Inchip replacement, Ranawat/Burnstein Acetabular Shellhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114365
mdprc 132 11 12 000bioMerieux IncAnalyzers, Sodium Chloride (NaCl) Injection.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114061
mdprc 107 11 12 000Zimmer incProstheses, Joint, Hip, Femoral Component, Multipolar Bipolar Cup Linershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112642
mdprc 106 11 12 000Zimmer incTrilogy II Constrained Liner The Trilogy Longevity Constrained Liner serves as the articular surface .http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112648
mdprc 105 11 12 000Siemens Healthcare DiagnosticsDimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridge (K4071)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111837
mdprc 104 11 12 000KCI USA IncRotoRest Delta Kinetic Therapy Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111749
mdprc 103 11 12 000Gyrus ACMITympanostomy tubehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114384
mdprc 102 11 12 000Carl Zeiss Meditec IncINTRABEAM Balloon Applicator Sethttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114297
mdprc 101 11 12 000NuVasive IncSpheRx® Posted Pedicle Screw Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=83509
mdprc 100 11 12 000MAKO Surgical CorpThe RIO ,surgical knee, orthopedic and hip procedure.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114357
mdprc 099 11 12 000Linvatec Corp.Drills, Surgical Bithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112472
mdprc 098 11 12 000Beckman CoulterIn vitro diagnostic , UniCel Dxl Access Immunoassay Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114074
mdprc 090 11 12 000Sorin GroupPump Control Panel, Stockert Centrifugal Pump, S5 and S3http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113636
mdprc 089 11 12 000OscorGuide Wires, Myocardial Heart Wireshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112581
mdprc 088 11 12 000Linvatec Corp.create pathway, CrossFT Suturehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112522
mdprc 087 11 12 000First Medical Source LLCInfusion Pump, WOLFPAK, Medpro, Vipathttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104881
mdprc 085 11 12 000Mindray DS USA, Inc.Mindray A5 Anesthesia Delivery Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113482
mdprc 084 11 12 000Extremity Medical LLCIntraOsseous Fixationhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112032
mdprc 083 11 12 000Moog IncInfinity Pumphttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114426
mdprc 082 11 12 000GE HealthcareElectrodes, Electrocardiographic, Neonatal, Corometrics Quik Connect Plus Spiral Electrodeshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113969
mdprc 081 11 12 000Zimmer incTourniquets, A.T.S. 3000 Automatic Tourniquet Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113932
mdprc 080 11 12 000GE HealthcareMobile X - Rayhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=114307
mdprc 079 11 12 000SorinFittings/Adapters, Luer, Gish Connector with Luer fittinghttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113571
mdprc 078 11 12 000Progressive Medical IncDissectors, Endoscopic Dissectors with Kittner Tipshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110395
mdprc 077 11 12 000OrthosensorGraphic user interface, ORTHO SENSORhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112490
mdprc 076 11 12 000Nipro CorpGuide Wires, Various Aqualiner Hydrophilic Guidewireshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113448
mdprc 075 11 12 000GE HealthcareWorkstations, Multiple Modality, Three-Dimensional Image, Seno Advantage 2.2 Workstationshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108537
mdprc 074 11 12 000Encore Medical, LpBone Screw, 6.5mm Cancellous Bone Screwhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113489
mdprc 073 11 12 000Elekta IncRadiation treatment planning software, Oncentra External Beam 4.1http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113697
mdprc 072 11 12 000DePuy International LimitedSuture Anchors, SPIRALOK Suture Anchorshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112639
mdprc 071 11 12 000Baxa CorpFluid Transfer Tube Sets, Repeater Pumphttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113637
mdprc 070 11 12 000Ethicon IncSURGIFLO HEMOSTATIC MATRIXhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113490
mdprc 069 11 12 000bioMerieux IncBioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML02http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113980
mdprc 068 11 12 000Synthes IncSynthes External Fixation Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113797
mdprc 067 11 12 000Terumo Cardiovascular Systems CorporationHX2 Temperature Management Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113534
mdprc 066 11 12 000Terumo Cardiovascular Systems CorporationArterial perfusionhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111544
mdprc 065 11 12 000Trivascular IncTriVascular brand Fill Polymer Kithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=1142
mdprc 064 11 12 000Dako North America IncPT Link Waterbathhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=85291
mdprc 061 11 12 000Micro Therapeutics IncUltraFlow HPC Flow Directed Micro Catheterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112884
mdprc 060 11 12 000Zimmer incDrills, Bone, Cemented Tibial Drills Used with Persona Personalized Knee Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112646
mdprc 059 11 12 000Zimmer incProstheses, Joint, Hip, Femoral Component, MIS and VerSys Provisional Femoral Head Prostheseshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112435
mdprc 058 11 12 000Stanley Healthcare SolutionsMonitors, TABS Professional Monitorshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109106
mdprc 057 11 12 000Philips HealthcareStationary radiographic Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112761
mdprc 056 11 12 000Invacare Corporation.Chairs, Bath, I-Fit Shower Chairshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112225
mdprc 055 11 12 000KCI USA IncMattress Systems, Low-Air-Loss, BariAir Therapy Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112188
mdprc 054 11 12 000EOS ImagingEOS X-ray Medical Diagnostichttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111193
mdprc 053 11 12 000Biomet IncScrewdrivers, Bone, OptiLock Screwdrivers and Insertershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112460
mdprc 052 11 12 000Imaging Sciences International IncDEXIS Imaging Suitehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111796
mdprc 051 11 12 000Westmed IncPulset Arterial Blood Gas (ABG) sampling kit, TRIAD brand alcohol padshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113400
mdprc 050 11 12 000Ethicon IncAdhesives, EVICEL Fibrin Sealanthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113110
mdprc 049 11 12 000DePuy International LimitedRadiofrequency System, VAPR Hook Electrode 3.5mm Hook Electrode with Integrated Handpiecehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113405
mdprc 048 11 12 000GreatbatchSteerable Sheathhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112674
mdprc 047 11 12 000Beckman Coulter IncIVD, clinical chemistry analyzers, UniCel® DxC 600/800 Synchron® Clinical Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112676
mdprc 046 11 12 000AdvanDx, IncIVD, E. coli/P. aeruginosa PNA FISHhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112961
mdprc 045 11 12 000AdvanDx, IncIVD, Identification Kit for Escherichia coli,and/or Klebsiella pneumoniae and/or Pseudomonas aeruginosa, GNR Traffic Light PNA FISHhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113037
mdprc 044 11 12 000Advanced Bionics Corp.HiResolution Bionic Ear System, HiRes 90K cochlear implant with HiFocus Helix Electrodehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=113560
mdprc 043 11 12 000Progressive Medical IncEndoscopic Dissector with Kittner Tip (5mm c 40cmFDA
mdprc 042 11 12 000Alphatec Spine IncZodiac Pedicle Screw SystemFDA
mdprc 037 11 12 000Primus Medical LLCPrime Bed TL500 Bed FrameFDA
mdprc 036 11 12 000Neomend IncProgel Pleural Air Leak SealantFDA
mdprc 035 11 12 000Linvatec Corp.Light Source, Endoscopic, Xenon ArcFDA
mdprc 034 11 12 000Hologic IncHologic Fluoroscan Mini C-ArmFDA
mdprc 033 11 12 000Alere LTDReagents, Immunoassay, Rapid Test, Drug-of-Abuse, Triage TOX Drug Screen 9-Panel Reagent KitsFDA
mdprc 032 11 12 000Terumo Cardiovascular Systems CorporationHeart-Lung Bypass Units, Terumo Advanced Perfusion System 1 Flow ModulesFDA
mdprc 030 11 12 000Terumo Cardiovascular Systems CorporationHeart-Lung Bypass Units, Terumo Advanced Perfusion System 1 Flow ModulesFDA
mdprc 029 11 12 000Philips Medical SystemsComputed Tomography X-Ray SystemsFDA
mdprc 028 11 12 000Beckman Coulter Incimmunoradiometric assay kit , Active Renin IRMA KitFDA
mdprc 027 11 12 000Accuro Medical Product LLCNegative Pressure Wound Therapy Powered Suction PumpFDA
mdprc 026 11 12 000US EndoscopyRaptor Endoscopic retrieval device.FDA
mdprc 025 11 12 000Synthes IncSynthes Minimally Invasive Reduction Screw System (MIRS)FDA
mdprc 024 11 12 000Cure Medical LlcMale, 16Fr, Straight-tip Intermittent Urinary Catheters M16FDA
mdprc 023 11 12 000Beckman Coulter IncIMMAGE Immunochemistry Systems Rheumatoid Factor (RF) ReagentFDA
mdprc 048 10 12 000Cordis CorporationSleek OTW***REF 426-1201X***Inflated BalloonFDA
mdprc 047 10 12 000Opti Medical Systems IncBP7561 OPTI CCA-TS B-Lac CassetteFDA
mdprc 046 10 12 000CovidienCovidien Duet TRS Loading UnitFDA
mdprc 045 10 12 000Accutron IncNewport Portable PackageFDA
mdprc 037 10 12 000Siemens Medical SolutionsMobile x-ray system, Mobilett MiraFDA
mdprc 036 10 12 000Edwards LifesciencesCatheters, Swan-Ganz Thermodilution VIP CathetersFDA
mdprc 033 10 12 000Steris CorpSurgical TablesFDA
mdprc 032 10 12 000Smith & Nephew OrthopaedicProstheses, Joint, Hip, Femoral Component, 12/14 Taper High Offset NecksFDA
mdprc 031 10 12 000Baxter HealthcareBaxter Clearlink System Buretrol Solution Set with 150 mL Burette - Non-DEHPFDA
mdprc 030 10 12 000Haag-Streit AGOctopus 101 PerimeterFDA
mdprc 029 10 12 000Custom Medical Specialties, IncPovidine-Iodine prep solution/Providine prep padsFDA
mdprc 028 10 12 000Depuy Orthopaedics, IncS-Rom® Total Hip System Poly LinerFDA
mdprc 027 10 12 000Steris CorporationVerify® Bowie-Dick Test CardFDA
mdprc 026 10 12 000Sekisui DiagnosticsSpectrolyse PAI-1FDA
mdprc 025 10 12 000Roche Diagnostics CorpAmplilink Software v3.2FDA
mdprc 024 10 12 000Integra LifeSciences CorporationHead Ring Assembly with Intubation Mounts (HRAIM)FDA
mdprc 023 10 12 000DavolBard Ventralight ST Mesh. - Ellipse 8" x 10" (20.3 cm x 25.4 cm) Product Code 5954810FDA
mdprc 022 10 12 000Asahi Kasei Medical CoHemodialyzerFDA
mdprc 021 10 12 000Kimberly Clark Health CareKimberly-Clark MIC PEG Kit - Pull TypeFDA
mdprc 020 10 12 000ZOLL Medical CorpDefibrillator/Pacemaker/Monitor, Zoll X SeriesFDA
mdprc 019 10 12 000US EndoscopyCytology Brush,used to retrieve cytological cell samples in the gastrointestinal tractFDA
mdprc 018 10 12 000Steris CorpGeneral surgical table,Amsco 3085SPFDA
mdprc 017 10 12 000Biomet IncBiomet Juggerknot in Guide PunchFDA
mdprc 016 10 12 000BD BiosciencesBD FACS 7-color Setup beads, for in vitro diagnostic use on BD FACSCanto or BD FACSCanto II systems. The beads are run with BD FACSCanto clinical softwareFDA
mdprc 001 10 12 000Terumo Cardiovascular Systems CorporationTerumo Advanced Perfusion System 1 System 1 Base and Electronic O2 Blender/AnalyzerFDA
mdprc 178 09 12 000Lucero MedicalBone Matrix Implants, Synthetic, Enduramesh Corpectomy Spacer Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112080
mdprc 177 09 12 000Kimberly Clark Health CareWarming Units, Model 1000 Patient Warming System Control Unitshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111119
mdprc 176 09 12 000GE HealthcareDiagnostic imaging systems, Advantage Worksation version 4.2 and 4.3http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108540
mdprc 156 09 12 000Tedan Surgical Innovations Llcfixation, Sterile Distraction Screwshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112010
mdprc 155 09 12 000Spacelabs Healthcare IncMonitor, Ultraview DM3 Monitorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112079
mdprc 154 09 12 000Philips Healthcareradiographic, DigitalDiagnost Systems with M Cabinethttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111935
mdprc 153 09 12 000OMNIlife scienceApex Knee System Modular Tibia Augmenthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112024
mdprc 152 09 12 000Instrumentation LaboratoryAutomated Coagulation Analyzerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111953
mdprc 151 09 12 000GE HealthcareRadiographic Units, Mobile, Optima XR200amx and XR220amx Mobile Radiographic Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112107
mdprc 150 09 12 000GE HealthcareAutomatic Mobile X-Ray, Optima Mobile X-ray Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110854
mdprc 149 09 12 000Capsule Tech IncComponent in the DataCaptor Connectivity System, Capsule Neuron Docking Stationhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111859
mdprc 148 09 12 000Biosense Webster Inc.catheter-based atrial and ventricular mapping, CARTO 3 V1.05 Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=88917
mdprc 135 09 12 000Medtronic Xomed IncMonitor, Nerve Integrity Monitor 3.0 Patient Interfaceshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112330
mdprc 134 09 12 000Hospira IncInjectors, Medication/Vaccine, 30 mL Sterile Empty Vials and Injectors Used with PCA Pumpshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112021
mdprc 133 09 12 000ExactechImplantation of Novation Hip system components, NOVATION MODULAR DRILL BIThttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110251
mdprc 110 09 12 000Sunquest Information Systems IncInformation Systems, Data Management, Sunquest Laboratoryhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111675
mdprc 109 09 12 000Steris CorpSYSTEM 1E Liquid Sterilant Processing Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111958
mdprc 108 09 12 000Siemens Medical SolutionsMobile X-Ray System, Siemens Mobilett Mirahttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112355
mdprc 107 09 12 000RaySearch Laboratories ABRadiotherapy, RayStation Softwarehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112152
mdprc 106 09 12 000JK Products & Services, IncUltraviolet Radiation, SUN|DASH RADIUS 252 tanning systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111444
mdprc 105 09 12 000Custom Medical Specialties, Incbottle PVP Prep Solutionhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111924
mdprc 104 09 12 000Breg Inc, An Orthofix Companyinsulation barrier, Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breghttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98803
mdprc 103 09 12 000Becton Dickinson & Co. (BD)IVD, GeneOhm Cdiff Assay , GeneOhm MRSA ACP Assay, GeneOhm VanR Assayhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110805
mdprc 102 09 12 000Bard Pcripheral Vascular (BPV)Bard Foley procedural trays packaged in breather bagshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111691
mdprc 101 09 12 000AmeriWaterWater Purification Systems, Reverse Osmosis, Hemodialysis, Portable, Model MRO Portable RO+ Reverse-Osmosis Systems.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111946
mdprc 100 09 12 000Aesculap IncFixation, Aesculap S4 Element 4.5mm Polyaxial Screwshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111846
mdprc 099 09 12 000Toshiba Corp Medical Systems Co LtdWhole Body X--ray Scanner, CT systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=84557
mdprc 098 09 12 000Steris CorpQuick Connect device connects endoscopes to the sterilization tray, QKC1692Ehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111699
mdprc 097 09 12 000Mediline Industries, Inccutting and coagulation of soft tissue, Electrosurgicalhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111229
mdprc 096 09 12 000GE Medical SystemsOEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); IT3500 (InstaTrak); IT3500 Plus (InstaTrak Plus); ConneCTstat; and ConneCTstat Plus picture archiving and communications systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111483
mdprc 095 09 12 000ExactechOptetrak Logic Total Knee System, OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZEDhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109647
mdprc 094 09 12 000Encore Medical, Lpmore closely match the kinematics of the knee, 3DKnee e+ Tibial Insert,http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111744
mdprc 093 09 12 000Cook MedicalStents, Vascular, 5 Fr Zilver 518 Vascular Self-Expanding Stentshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108136
mdprc 092 09 12 000Capintec Incmeasurement of organ uptake and circulating radioactivity, Capintec Captus 3000 Thyroid Uptake Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112193
mdprc 091 09 12 000Atlas SpineScrewdrivers, Bone, Apelo Modular Screwdrivers Used with Apelo Pedical Screw Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111339
mdprc 090 09 12 000Advanced Sterilization ProductsHigh Level Disinfectant Solutionm, CIDEX OPAhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=112036
mdprc 089 09 12 000Toshiba Corp Medical Systems Co LtdScanner, Computed Tomography, X-Rayhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111873
mdprc 088 09 12 000Terumo Cardiovascular Systems CorporationPumps, Extracorporeal Perfusionhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111352
mdprc 087 09 12 000Sunquest Information Systems IncInformation Systems, Data Management, Laboratory, Laboratory Information System Software Using Microbiology Result Entryhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111472
mdprc 086 09 12 000Stryker Medicaltransport a seated patient, Powered Mobility Offers Versatility (M®V)TM Chair1http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108686
mdprc 085 09 12 000Philips Medical SystemsPositron Emission Tomography (PET) and X-ray Computed Tomographyhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111947
mdprc 084 09 12 000MedtronicRadiographic/Fluoroscopic Units, Mobile, O-Arm Imaging Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111068
mdprc 083 09 12 000Hitachi Medical CorpSoftware controlled MRI devices, Hitachi Echelon MRI System/Oasis MRhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111915
mdprc 082 09 12 000GE Medical Systemspicture archiving and communications system, OEC InstaTrak 3500http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111580
mdprc 081 09 12 000GE Medical Systemsfluoroscope X-ray, GEHC OEC Injection Cable for MedRad Provis V Contrast Injector.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111583
mdprc 080 09 12 000GE Medical SystemsImage-intensified fluoroscopic x-ray system, GE OEC 9800http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111381
mdprc 079 09 12 000ExactechOptetrak Comprehensive Knee Systems, LOGIC Proximal Tibial Spacer Size 2.5http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109896
mdprc 078 09 12 000Canon IncCanon Solid Stale X-ray Imaqer (Flat Panel/Digital Imager)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111794
mdprc 077 09 12 000Beckman Coulter IncIVD, UniCel DxI and DXC Immunoassay Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111461
mdprc 076 09 12 000Afassco Inccover a fingertip bandage, finger cotshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111455
mdprc 075 09 12 000Varian Medical SystemsInformation Systems, Data Management, Oncology, Radiotherapyhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111025
mdprc 074 09 12 000Synthes IncBone Matrix Implants, Hemostatic Bone Puttyhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111111
mdprc 073 09 12 000stryker spineDistract the disc space, Reliance AL Implant Blockerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110439
mdprc 072 09 12 000Siemens Medical SolutionsInformation Systems, Data Management, Cardiology, syngo Dynamics Servershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111087
mdprc 071 09 12 000Siemens Healthcare DiagnosticsIVD, syngo(R) Lab Data Managerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110419
mdprc 070 09 12 000SenTec AGDigital Monitoring System, SenTec, V-Sign"2 Sensorshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111100
mdprc 069 09 12 000Philips Medical SystemsComputed Tomography Scanners, The Brilliance 64 and Ingenuity CThttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111235
mdprc 068 09 12 000Philips HealthcareRadiographic Systems, Digital, Essenta DR Compact Digital Radiography Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111267
mdprc 067 09 12 000Philips HealthcareRadiographic/Fluoroscopic Systems, Easy Diagnost Classic-Stationary x-ray systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111064
mdprc 066 09 12 000Nico CorpAccess to neurological tissues, BrainPath Sheathhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111098
mdprc 065 09 12 000Maquet Cardiopulmonary AGCannulae, Arterial, Pediatric Arterial Cannulaehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110719
mdprc 064 09 12 000Institut StraumannDental implant suprastructure, Straumann Narrow CrossFit (NC) Screw for CARES Abutment ZrO2http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111078
mdprc 063 09 12 000GE HealthcarePortable, OEC 8800 Mobile Fluoroscopic X-ray Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111739
mdprc 062 09 12 000Depuy Orthopaedics, IncImplants, Altrx" Altralinked" Polyethylene linershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111266
mdprc 061 09 12 000DePuy International LimitedProstheses, Various Custom Implantshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111674
mdprc 060 09 12 000CareFusion..Infusion Pumps, Model 8100 Alaris Pump Moduleshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=89956
mdprc 059 09 12 000CareFusion..Infusion Pumps, Alaris Pump Module Model 8100http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111240
mdprc 057 09 12 000Sunrise MedicalPadded, swing-away armrests on Quickie Q7, GT, GTi and Zippie Zone wheelchairshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110756
mdprc 056 09 12 000stryker spineLUXOR RETRACTOR BASEhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111265
mdprc 055 09 12 000Medical Specialties DistributorsInfusion Pump Administration Sets, Medstream Universal Administration Setshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111584
mdprc 053 09 12 000Greiner Bio-One IncTubes, Blood Collection, 3 mL 9NC Coagulation Tubes Containing Sodium Citratehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111118
mdprc 052 09 12 000Finapres Medical SystemsRecorders, Electronic Storage, Data, Blood Pressure, Portapres Ambulatory Continuous Noninvasive Blood Pressure Monitorshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110979
mdprc 051 09 12 000Encore Medical, Lpbone screw, djo surgical6.5 mm cancellous bone screwhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111018
mdprc 050 09 12 000Apheresis Technologies, IncSeparators, Plasma, Model PP-04a Plasma Pumps Used with Asahi Plasmaflo Plasma Separatorshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111049
mdprc 047 09 12 000TransEnterixClip Appliers, Gastrointestinal, Endoscopic, SPIDER Surgical System Flexible Clip Appliershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111090
mdprc 046 09 12 000Steris CorpMechanical washer, RELIANCE® 130 and 130L CART WASHERhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110984
mdprc 045 09 12 000Smith & Nephew incDyonics Electroblade Resector, Full Radius Blade, BONECUTTERhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111171
mdprc 044 09 12 000SCC Soft ComputerInformation Systems, Data Management, Laboratory, SA INST Applications Used with SoftLab Software and Specific Sysmex Instrumentshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109709
mdprc 043 09 12 000ICU Medical, IncStopcocks, High-Pressure Stopcockshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110877
mdprc 042 09 12 000GE Medical Systemsfluoroscopic, spot-film imaging, OEC MiniView 6800 Mobile, UroView 2800 and OEC 9800 Plushttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110685
mdprc 041 09 12 000Beekley CorpMarkers, Skin, Medical SPOTS Digital Skin Markershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110840
mdprc 040 09 12 000Aesculap IncAesculap SIBD 4 degree Trial Implant and Aesculap SIBD 9 degree Trial Implanthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111198
mdprc 039 09 12 000Abbott Point of CareQuantitatively measure, I-STAT EG7+ Cartridgehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110354
mdprc 037 09 12 000The Anspach Effort, Inc.Burs, Surgical, Bone Cutting Burshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110229
mdprc 036 09 12 000Neusoft Medical SystemsCT Scanner, NeuViz 16 Multi-Slice CT Scanner Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110741
mdprc 035 09 12 000Mallinckrodt BakerSterile plastic tube, Handi-Fil Disposable Syringe Fill Tubehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=89069
mdprc 034 09 12 000Hospira IncIntravenous Administration Sets, 100 mL x 77-Inch Convertible Pin Burette Setshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=111089
mdprc 033 09 12 000Getinge Disinfection ABSterilizing Units, 9100 Series Electrically Heated Washer-Disinfectorshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109621
mdprc 032 07 12 001Ethicon IncSurgiflo Hemostatic Matrix Kit with Thrombin Plus Flex Tiphttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109783
mdprc 090 08 12 000Synthes Incspinal fixation, Universal Spinal System Lamina Hookshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110226
mdprc 089 08 12 000OrthoPediatrics CorpPlates, Bone, 4.5 mm Right Locking Contoured Compression 8-Hole Plates Used with PediLoc Femur Locking Plate Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110311
mdprc 088 08 12 000Exactech Inc. Optetrak Cemented Trapezoid Tibial Tray and Optetrak Rotating Bearing Knee Tibial Trayhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109674
mdprc 087 08 12 000Varian Medical Systemsradiotherapy, Eclipse Treatment Planning Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110464
mdprc 086 08 12 000Philips HealthcareComputed Tomography, X-Ray Systems, Various Brilliance and Ingenuity Computed Tomography Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110763
mdprc 085 08 12 000Hitachi Medical CorpScanning Systems, Computed Tomography, Scenaria Computed Tomography System Softwarehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110356
mdprc 084 08 12 000GE Medical SystemsImage-intensified fluoroscopic x-ray system, OEC FluoroTrak 9800 Plushttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=79254
mdprc 081 08 12 000Bridgepoint MedicalStingray Catheterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110688
mdprc 080 08 12 000Alere San DiegoReagents, Triage Tox+MTD Drug Screenhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110155
mdprc 079 08 12 000AGFA Corp.Information Systems, IMPAX Cardiovascular Reporting Non-Invasive Vascular Results Management Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110871
mdprc 013 08 12 000Terumo Cardiovascular Systems CorporationThe Terumo Advanced Perfusion System 1http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108925
mdprc 012 08 12 000Smiths MedicalMedfusion® Syringe Infusion Pumphttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107652
mdprc 011 08 12 000LMA North America IncDetectors, Esophageal Intubation Detectorshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110279
mdprc 010 08 12 000Integra LimitedEndoscopic Instruments,Integra(TM) Jarit(R) Take-Apart Endoscopic Instrumentshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110714
mdprc 009 08 12 000Gulf Fiberoptics, IncGMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlinkhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110426
mdprc 008 08 12 000Stingray Surgical Products, LLCgeneral surgical procedures, Bipolar Forcepshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109874
mdprc 007 08 12 000Spacelabs Healthcare IncMonitor, Xprezzon Bedside Monitorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110571
mdprc 006 08 12 000Kimberly Clark Health CareMicroCool Breathable Impervious Surgical Gownhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110687
mdprc 005 08 12 000GE HealthcarePhysiologic Monitor Modules, Invasive Blood Pressure Care Cableshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109880
mdprc 004 08 12 000Etacwheeled walkers , Etac® Ono Walker, Etac® Avant Walker, and Etac® Salsa Walkerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108163
mdprc 003 08 12 000DeRoyal Industries IncSurgical Kits and Trays, GEO-MED TOTAL KNEE PACK PGYBKhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110698
mdprc 002 08 12 000Abbott Molecular Inc Sub Abbott LaboratoriesBar Code Scanner User's Guidehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110232
mdprc 076 06 11 001CMS Inc Div Elekta ABRadiation Treatment Planning Systems, XiOhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98830
mdprc 111 07 12 000PSC Industries IncElectrosurgical Irrigating Bipolar Forcepshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110247
mdprc 110 07 12 000Philips HealthcareDefibrillator/Pacemakers, Model M3536A HeartStart MRx Monitor/Defibrillatorshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110296
mdprc 109 07 12 000Integra LifeSciences CorporationCatheter Flush Valves, Pudenz Flushing Valves with Integral Connectorshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109901
mdprc 108 07 12 000Respironics IncRespironics Trilogy systems,Ventilatorshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110401
mdprc 107 07 12 000CareFusion.Infusion Pumps, Model 8015 Alaris PC Unit Infusion Pumpshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109684
mdprc 017 09 11 001Hospira IncDocking Stations, GemStar Infusion Pumphttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102851
mdprc 070 07 12 000Terumo Cardiovascular Systems CorporationPerfusion, Advanced Perfusion System 1 Baseshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108194
mdprc 069 07 12 000Terumo Cardiovascular Systems CorporationPerfusion,Terumo Advanced Perfusion System 1http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110340
mdprc 068 07 12 000Smiths MedicalWarming Units, HOTLINE 3 Blood and Fluid Warmershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110397
mdprc 067 07 12 000GE HealthcareImage Processing System, GE Advantage CT/PET Fusionhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108503
mdprc 066 07 12 000Edwards LifesciencesSuction Kits, Rigid Suction Wand Cathetershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=82771
mdprc 065 07 12 000Cardiovascular Systems, IncStealth 360-degree Orbital Atherectomy Devicehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110453
mdprc 064 07 12 000Terumo Cardiovascular Systems CorporationCentral Control Monitor , Advanced Perfusion System 1 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110370
mdprc 063 07 12 000Encision IncElectrodes, AEM Disposable Electrodeshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108356
mdprc 062 07 12 000Civco Medical Instruments IncSensor,electromagnetic sensorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109099
mdprc 061 07 12 000CareFusion.Ventilators, EnVe Ventilatorshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110307
mdprc 057 07 12 000Invacare CorporationPower Wheelchair, TDX SP, TDX SR, TDX SI Power Wheelchairhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108412
mdprc 056 07 12 000Elekta/IMPACOncology Information Systems , MOSAIQ http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110188
mdprc 055 07 12 000Thayer Medical CorporationInhalers, AirLife MiniSpacer Metered Dose Inhaler Adaptershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110105
mdprc 054 07 12 000Pride Mobility Products Ltdwheelchair, Victory 9 with Power Seat (SC609PS) Motorized wheelchair with elevating seat.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=95926
mdprc 053 07 12 000GE Medical SystemsImage Processing System, InstaTrak with Multiple Dataset Navigationhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109866
mdprc 036 07 12 000Polymer Technology Systems, Inc.Test strips, PTS Panels Creatinine test stripshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109606
mdprc 034 07 12 000Salter LabsDelivery of Anesthesia, Adult Divided Cannula end tidal Co2 sampling w/male luer-lock connectorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110043
mdprc 033 07 12 000Medical Components, IncPolyurethane Catheter, 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable Chronoflex(R) Polyurethane Catheter.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=110003
mdprc 031 07 12 000Zimmer incDrills, 6 mm Bigliani/Flatow Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drills with Stopshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109571
mdprc 030 07 12 000Terumo Cardiovascular Systems CorporationCannulae, Sarns Antegrade Cardioplegia Cannulaehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108818
mdprc 029 07 12 000Alere San Diego`Reagents, Immunoassay, Various Triage Immunoassay Reagentshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109501
mdprc 152 06 12 000Stryker EndoscopyHandpiece, Formula 180 Shaver Hand Controlhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109573
mdprc 151 06 12 000Medtronic Navigation IncMobile x-ray system , 0-arm® Imaging Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108856
mdprc 150 06 12 000Hartmann USA, IncHartmann Econolux Sterile Gauze sponge and Sterile Premium gauze spongehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109341
mdprc 149 06 12 000Genzyme Diagnostics Div Genzyme CorpFilms, Seprafilm Adhesion Barriershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109888
mdprc 148 06 12 000Accumetrics IncWhole blood assay, VerifyNow P2Y12 assay devicehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109704
mdprc 134 06 12 000Stryker InstrumentsBarrier, Hytrel Zipper Togahttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109236
mdprc 133 06 12 000Non-Invasive Monitoring Systems, IncAcceleration Therapeutics device, Exer-Rest devicehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109263
mdprc 132 06 12 000Ultradent Products, IncSyringe, Peak SE Primer Refillhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109878
mdprc 131 06 12 000Philips HealthcareStationary Fluoroscopic system, Easy Diagnosthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109279
mdprc 130 06 12 000Arrow International IncPressure Injectable Central Venous Catheter, 7FR 3-Lumen Arrowg+ard Blue Plus®http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109883
mdprc 129 06 12 000App Pharmaceuticals LlcHEPARIN LOCK FLUSH SOLUTIONhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97659
mdprc 106 06 12 000Vygon UK LtdSyringes, Flush Heparin Lock Flush Syringeshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109541
mdprc 105 06 12 000GE HealthcareAnesthesia machine, Aestiva/5 7900 SmartVenthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108604
mdprc 092 06 12 000Sigma International LLCSpectrum VOLUMETRIC INFUSION PUMPhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107879
mdprc 091 06 12 000Philips Medical SystemsComputed Tomography X-Ray Systems, The Brilliance iCT and iCT SPhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109268
mdprc 090 06 12 000GE Medical SystemsDigital Radiographic System, Definium 8000, Silhouette FC(Proteus XR/a) and Revolution XR/dhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=51230
mdprc 088 06 12 000Captiva Spine, IncLumbar spine, Spinal Invervetebral Disc Space Orthosishttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109497
mdprc 087 06 12 000MicroAire Surgical InstrumentsLiposuction procedures, Lipofilter 3000http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109241
mdprc 065 06 12 000Spacelabs Healthcare IncMonitor, Xprezzon Bedside Monitorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109489
mdprc 064 06 12 000Excelsior Medical CorpInfusion therapy, Heparin Lock Flush http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109178
mdprc 058 06 12 000Invacare CorporationWalkers, Knee Walkershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108408
mdprc 054 06 12 000Water Pik, IncSinus washing, Water Pik Sinusense battery operatedhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108365
mdprc 053 06 12 000Stryker OrthopaedicsRestoration HA cementless Hip Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107822
mdprc 052 06 12 000Siemens Medical Solutionse.cam Emission Computed Tomography Systems and Symbia E Series SPECT Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108691
mdprc 051 06 12 000Moog IncCurlin® Infusion Administration Sethttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109321
mdprc 050 06 12 000Genesys Orthopedic SystemsTransforminal Lumbar Interbody Fusion (TLIF) PEEK Inserterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108603
mdprc 049 06 12 000CovidienSyringes, Monoject Insulin Safety Syringeshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109368
mdprc 048 06 12 000CaridianBCT IncSpectra Optia Apheresis Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109094
mdprc 047 06 12 000ConMed CorporationAltrus Energy Source, Tissue Fusion Energy Sourcehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109155
mdprc 046 06 12 000ConMed CorporationAltrus Thermal Tissue Fusionhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109176
mdprc 045 06 12 000Alphatec Spine IncSOLUS Anterior Lumbar Interbody Fusion Spinal Spacer Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108936
mdprc 015 06 12 000Philips Medical SystemsIngenuity TF PET/MRI Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109141
mdprc 014 06 12 000Medical Components, Inc8F Plastic Dignity Mid-Sized CT Port, ChronoFlex Polyurethane Catheterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109257
mdprc 013 06 12 000Diamedix CorporationENA-6 Screen Enzyme Immunoassay Test Kithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108435
mdprc 012 06 12 000Biosense Webster Inc A Johnson & Johnson CoEZ STEER Catheter, Cardiovascular catheterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=70961
mdprc 011 06 12 000Arcadia Medical CorporationSilicone Cuffed Wire Reinforced Extended Connect Pediatric Perfect Fit Neck, Flange Tracheostomy Tube http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108664
mdprc 007 06 12 000Vascular Solutions IncCatheters, GuideLiner V2 Cathetershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109189
mdprc 006 06 12 000College Park Industries, IncCelsus prosthetic foothttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108756
mdprc 005 06 12 000CMS Inc Div Elekta ABXiO Radiation Treatment Planning Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108860
mdprc 004 06 12 000Captiva Spine, IncDrill Bits for Cervical Plate Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109147
mdprc 003 06 12 000Apheresis Technologies, IncPlasmaPro Plasma Pumphttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108552
mdprc 002 06 12 000Pharmaceutical Innovations, IncOther-Sonic Generic Ultrasound Transmission Gelhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108813
mdprc 001 06 12 000Baxa CorpAbacus TPN Calculating Softwarehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=81907
mdprc 076 05 12 000Varian Medical SystemsRadiotherapy Systems, TrueBeam and TrueBeam STxhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108735
mdprc 075 05 12 000MEDDEV USA, INC50 Portal Vein Cannula, infusionhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109248
mdprc 074 05 12 000Fresenius Medical CareNaturalyte Acid Concentrate for bicarbonate Dialysishttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108033
mdprc 073 05 12 000Ellman International, IncPelleve hand pieceshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109119
mdprc 061 05 12 000Thera Test Laboratories, IncDiagnosis of Rheumatoid Arthritis (RA), RF IgA Calibratorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108288
mdprc 060 05 12 000North Coast Medical IncExercisers, Norco Shoulder Pulleyshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108183
mdprc 059 05 12 000Captiva Spine, IncSpinal Intervertebral body Fixation Orthosis, SmartLOXhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109124
mdprc 058 05 12 000Terumo Cardiovascular Systems CorporationCAPIOX FX Hollow Fiber Oxygenatorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108803
mdprc 057 05 12 000Steris CorpEvolution steam sterilizershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109080
mdprc 056 05 12 000Mitaka USA, IncSurgical instruments, Point Setterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=83534
mdprc 055 05 12 000Haemacure CorpoHemaSyst, Dual cannula Tip with Adapterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108601
mdprc 054 05 12 000GF Health ProductsLUMEX A Graham-Field Brand, Bed End Serthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108355
mdprc 053 05 12 000CaridianBCT IncTrima Accel Automated Blood Collection Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=109058
mdprc 052 05 12 000Zimmer incZimmer® 4.1 Trabecular Metal" Dental Implanthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108234
mdprc 051 05 12 000O'Ryan Industries IncDental curing light, DISPOSA-SHIELDhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108697
mdprc 050 05 12 000MichClone Associates, IncBioTron Sickle Cell Reagent Sethttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107977
mdprc 049 05 12 000International Medsurg ConnectionDual X-Ray Gauzehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108705
mdprc 048 05 12 000CaridianBCT IncCaridian BCT COBE Spectra System Blood Warmerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108941
mdprc 037 05 12 000Siemens Medical SolutionsSiemens-branded ONCOR" or PRIMUS" linear accelerator with an OPTIVUE" or MVision" imaging systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108458
mdprc 036 05 12 000Sandhill Scientific IncInSIGHT Gastrointestinal Motility Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=86301
mdprc 019 05 12 000Wright Medical Technology IncVALOR(TM) TTC FUSION, INSTRUMENT KIThttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108522
mdprc 018 05 12 000Siemens Medical SolutionsARTISTE, ONCOR and PRIMUS Linear Accelerator systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108392
mdprc 017 05 12 000Hospira IncLifeShield Primary Plumsethttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108703
mdprc 015 05 12 000Stanley Healthcare SolutionsMonitors, Micro-Tech Informer Plus Silver Monitorshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106247
mdprc 014 05 12 000Ogenix CorporationTransdermal continuous oxygen therapy, EPIFLOhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108599
mdprc 013 05 12 000Churchill Medical SystemsLatex-Free Winged Infusion Sethttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108644
mdprc 012 05 12 000Biomet IncTrochanteric Nail. Longhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=108656
mdprc 150 04 12 000Alere LTDReagents, Alere Triage CardioProfiler PanelFDA
mdprc 148 04 12 000Stanley Healthcare SolutionsMonitor, UMP Personal Sentry Deluxe Pull String MonitorFDA
mdprc 147 04 12 000Philips HealthcareInformation system, monitor, eCareManager SystemFDA
mdprc 146 04 12 000Medical Information Technology, Inc.Laboratory instrument, software, MEDITECH Anatomical Pathology SoftwareFDA
mdprc 145 04 12 000Ortho-Clinical DiagnosticsChemistry Systems, VITROSFDA
mdprc 144 04 12 000Aesculap IncScrews, spinal, Quintex Cervical Plating System - ScrewsFDA
mdprc 143 04 12 000Winco, Inc.Chairs, Elite Care ClinerFDA
mdprc 142 04 12 000GE HealthcareX- Ray, GE Automatic Mobile X-Ray SystemsFDA
mdprc 141 04 12 000Fresenius Medical CareDialysis, Peritoneal, Fresenius Liberty CyclerFDA
mdprc 140 04 12 000Terumo Cardiovascular Systems CorporationPerfusion, Sarns Modular Perfusion System 8000FDA
mdprc 139 04 12 000Biomet IncJoint prosthesis, hip, Selex M2A Magnum Modular Head, 40 mmFDA
mdprc 138 04 12 000Abbott Laboratories IncReagents, ARCHITECT/AEROSET Activated Aspartate AminotransferaseFDA
mdprc 137 04 12 000Alere LTDReagents, Triage TOX Drug Screen (MTD) PanelFDA
mdprc 136 04 12 000Boston Scientific LtdMonitor, Latitude Patient Management System CommunicatorFDA
mdprc 135 04 12 000Biomet IncPlate prosthesis, OptilockFDA
mdprc 134 04 12 000Biomet IncProsthesis, MAK OSS No Head Lock PinFDA
mdprc 133 04 12 000Advanced Bionics Corp.Stimulator, The Precision Spinal Cord Stimulator SystemFDA
mdprc 132 04 12 000Synaptic CorpStimulator, cranial , SynapticFDA
mdprc 131 04 12 000Stryker Howmedica Osteonics CorpImplants, MEDPOR PLUSFDA
mdprc 130 04 12 000Teva Pharmaceuticals USA, Inc.Storage & collection devices, organ preservation fluid (for transport and storage), ViaSpan Cold Storage Solution 1000mL BagFDA
mdprc 129 04 12 000DePuy International LimitedProstheses, Joint, Knee, PFC Steinman Pin/Drill Pack SterileFDA
mdprc 128 04 12 000KCI USA IncMobility Assist & Trainer, Zuma Mobility SystemFDA
mdprc 127 04 12 000Abbott Laboratories IncIVDs clinical chemistry, Instrumentation, Clinical Chemistry Total BilirubinFDA
mdprc 126 04 12 000North Coast Medi-TekShower Bench, Norco Folding Shower BenchFDA
mdprc 124 04 12 000Beckman Coulter IncReagents, Synchron Ammonia (AMM) ReagentFDA
mdprc 084 04 12 000Roche Diagnostics CorpIVD, ACCU-CHEK Aviva Nano Blood Glucose MeterFDA
mdprc 079 04 12 000ScottCare CorpElectrocardiography, TeleSentry, Multi-parameter Ambulatory TelemetryFDA
mdprc 078 04 12 000Moog IncAmbulatory Pumps , Curlin Infusion Administration SetFDA
mdprc 077 04 12 000Baxa CorpFeeding systems, Baxa EVA TPN bagsFDA
mdprc 076 04 12 000DeRoyal Industries IncNeedle Sets, UmbilicupFDA
mdprc 075 04 12 000Boston Scientific CorporationCatheters, Boston Scientific, IMAGER II Urology Torque CatheterFDA
mdprc 074 04 12 000Siemens Healthcare DiagnosticsInformatics Systems, EasyLink Informatics SystemsFDA
mdprc 073 04 12 000Biocare Medical LlcIVD, Vina Green Chromogen KitFDA
mdprc 072 04 12 000Siemens Medical SolutionsX-Ray, Siemens Axiom Luminos dRF solid state x-ray imagerFDA
mdprc 071 04 12 000Siemens Healthcare DiagnosticsReagents, ADVIA Centaur Cortisol AssayFDA
mdprc 070 04 12 000Baxa CorpPharmacy compounding system, Exacta-Mix 2400(EM2400) Compounder Operating SystemFDA
mdprc 069 04 12 000Animas CorporationInsulin Pump , OneTouch(R) Ping(R) Insulin Pump glucose management systemFDA
mdprc 068 04 12 000Beckman Coulter IncIVD, Access Immunoassay SystemsFDA
mdprc 067 04 12 000Terumo Cardiovascular Systems CorporationBlood Parameter Monitoring System, CDI 500 MonitorFDA
mdprc 066 04 12 000Milabs BvCabinet of x-ray, U-SPECT-II/CT and VECTor/CT cabinet x-ray productsFDA
mdprc 065 04 12 000Hologic IncViewing images, Hologics SecurView DX workstationFDA
mdprc 064 04 12 000Baxa CorpIntravenous Solution Compounders, Exacta-Mix 2400 Compounder (EM 2400)FDA
mdprc 063 04 12 000Siemens Medical SolutionsMagnetic resonance, Siemens MAGNETOM VerioFDA
mdprc 062 04 12 000Acumed LLCBone Rod, The Polarus Plus Humeral RodFDA
mdprc 061 04 12 000Spinetronics, LLCLiterature, Antalgic-TrakFDA
mdprc 060 04 12 000Gendex Dental SystemsDental X-Ray System, Gendex eXpert DC IntraoralFDA
mdprc 059 04 12 000LifeScan, IncMonitors, Glucose, OneTouch Verio IQ Blood Glucose Monitoring System KitFDA
mdprc 055 04 12 000CMS Inc Div Elekta ABRadiation Treatment Planning System, MonacoFDA
mdprc 054 04 12 000Philips Medical SystemsComputed tomography, Brilliance 64 and Ingenuity CT Computed Tomography X-Ray SystemsFDA
mdprc 051 04 12 000Straumann USA, LLCDental implants , Straumann Standard Plus ImplantN/A
mdprc 050 04 12 000Optovue incOphthalmoscope, Cornea Power Kit (software)FDA
mdprc 049 04 12 000Fresenius Medical CareHemodialysis, Optiflux F160NRe HemodialyzerFDA
mdprc 048 04 12 000Stryker MedicalCritical Care Bed, EpicFDA
mdprc 047 04 12 000Aerolaselaser, Aerolase lasers, FriendlyLight YAG lasersFDA
mdprc 046 04 12 000Oridion Capnography IncMonitors, patient multi parameter monitor, Oridion CO2 sampling lines and water trapsFDA
mdprc 045 04 12 000Hamamatsu CorporationX-ray system, Hamamatsu Microfocus X-ray SourceFDA
mdprc 044 04 12 000Philips HealthcareX-Ray System, EasyDiagnost Eleva DRF 4.0FDA
mdprc 043 04 12 000Terumo Cardiovascular Systems CorporationHeart-Lung Bypass Units, Terumo Advance Perfusion System 1FDA
mdprc 042 04 12 000Biomet MicrofixationCutting tip, LactoSorb Heat/Contouring PenFDA
mdprc 041 04 12 000Becton Dickinson & Co. (BD)Bacteriology-Culture, BD BBL ™ Lowenstein-Jensen Medium DeepsFDA
mdprc 040 04 12 000Ortho-Clinical DiagnosticsAnalyzers, Laboratory, VITROS Chemistry Products dHDL SlidesFDA
mdprc 039 04 12 000PenlonAnesthesia Machines, Penlon Prima Anaesthesia Machines (SP2 and SP3) with Electronic Flowmeter DisplayFDA
mdprc 038 04 12 000RaySearch Laboratories ABRadiotherapy, RayStationFDA
mdprc 037 04 12 000Philips Medical SystemsX-Ray System, Philips Easy Diagnost Eleva DRFFDA
mdprc 036 04 12 000Biomet MicrofixationPlate prosthesis, Bone PlateFDA
mdprc 035 04 12 000Becton Dickinson & Co. (BD)Bacteriology-Culture, Fildes EnrichmentFDA
mdprc 034 04 12 000Philips Medical SystemsComputed tomography, Brilliance 64 and Ingenuity CTFDA
mdprc 033 04 12 000Medtronic VascularEndovascular approach, Talent Thoracic Stent Graft SystemFDA
mdprc 032 04 12 000Stryker Howmedica Osteonics CorpProthesis, Osteonics Shoulder Glenoid SpannerFDA
mdprc 031 04 12 000Christie Medical Holding IncNon- invasive electronic visual aid device, VeinViewerFDA
mdprc 030 04 12 000Ortho-Clinical DiagnosticsAnalyzers, Laboratory, VITROS Chemistry Products ALT SlidesFDA
mdprc 029 04 12 000Permobil ABPower wheelchair, Permolock C3FDA
mdprc 028 04 12 000Customed, IncWound Management TrayFDA
mdprc 027 04 12 000Siemens Healthcare DiagnosticsReagents, Immunoassay, ADVIA Centaur Vitamin D Diluent 2-packFDA
mdprc 026 04 12 000Ethicon Endo Surgery IncElectrosurgical Units, ENSEAL® 5 mm Diameter Tissue Sealer G2 14 cm & G2 14 cm Length Straight Curved JawFDA
mdprc 025 04 12 000Leica Microsystems Inc.Surgical microscope, Swingarm M820/M844 C19FDA
mdprc 024 04 12 000HealthTronics IncThermometers, Thermometers,Temperature Probes, CRYO Care Surgical SystemFDA
mdprc 023 04 12 000Siemens Medical Solutionslinear accelerators systems , Information System, MOSAIQ OncologyFDA
mdprc 022 04 12 000Biomet Incimplantation, screws, Micromax Anchors, Lactosorb AnchorsFDA
mdprc 109 03 12 000Medtronic MiniMedMedtronic MiniMed Paradigm Quick-set Plus Infusion Setshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=46837
mdprc 108 03 12 000GE HealthcareX-ray Imaging Systems, Innovahttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104048
mdprc 107 03 12 000Integra LifeSciences CorporationSurgical, EGR (Endoscopic Gastrocnemius Release Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107479
mdprc 106 03 12 000CovidienDUET TRS Loading Unitshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107642
mdprc 105 03 12 000Beckman CoulterSYNCHRON CX(r) systems, Immuno-Protein Calibrator Sethttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107339
mdprc 093 03 12 000Varian Medical SystemsNucletron Adapter and Transfer Guide Tube Sethttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107467
mdprc 092 03 12 000StrykerSoft tissue ablators, Reprocessed Mitek Arthroscopic Wandhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107760
mdprc 091 03 12 000Stryker InstrumentsBone cement pressurizers, Flat Proximal Pressurizerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106727
mdprc 090 03 12 000Mizuho OSIOrthopedic Systems, Coupler System IIhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107701
mdprc 089 03 12 000Kerr CorpAffix a temporary dental, TempSpan CMT Temporary Cementhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107695
mdprc 088 03 12 000Invacare CorporationTDX SP Power Wheelchairhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107440
mdprc 087 03 12 000Integra LifeSciences LtdIntegra CUSA Excel 23 KHz Sterile Tips Rxhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107298
mdprc 086 03 12 000CareFusionWet PVP-I Preoperative Skin Prep Tray with Powder-Free Esteem Gloveshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107312
mdprc 085 03 12 000Varian Medical SystemsFast Plan Treatment Planning Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107542
mdprc 084 03 12 000Philips HealthcareMult-functional diagnostic X-Ray system, DuoDiagnosthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107027
mdprc 083 03 12 000Philips HealthcareEasy Diagnost Eleva DRF, Fluoroscopic x-ray systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107557
mdprc 082 03 12 000Medical Positioning IncMPI Rapid Response HUT Tablehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107869
mdprc 078 03 12 000Visionsense LtdNeurological Endoscope, Visionsense Stereoscopic Vision System, VSIIhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107711
mdprc 077 03 12 000Varian Medical SystemsRadiology, TrueBeam Radiotherapy Delivery Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107546
mdprc 076 03 12 000Varian Medical SystemsRadiotherapy, Eclipse Treatment Planning Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107551
mdprc 075 03 12 000Sorin GroupMonitor, Control, Extracorporeal blood circulation. S5 Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107575
mdprc 074 03 12 000SIEMENSX-ray,Linear Accelerator, Siemens mMLC (ModuLeaf)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107631
mdprc 073 03 12 000Siemens Healthcare DiagnosticsIVD, Assay. ADVIA Centaur Intact PTH (iPTH)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105030
mdprc 072 03 12 000SIEMENSX-Ray, Imaging. Siemens Ysio, AXIOM Luminos dRF, AXIOM Luminos Agile/TF, Uroskop Omniahttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107662
mdprc 071 03 12 000Pointcare Technologies, IncIVD, Reagent. CD4NOW Gold Packhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107286
mdprc 070 03 12 000Philips Medical SystemsRadiography, Philips MultiDiagnost Elevahttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107690
mdprc 069 03 12 000Pelton & CraneDental operative unit, Spirit 3000http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107682
mdprc 068 03 12 000Ormco CorpDental, AdvanSync, orthodontic expansion screwhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106144
mdprc 067 03 12 000Microsoft Corporation Health Solutions GroupData management, Microsoft Amalga UIS 2009http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107082
mdprc 066 03 12 000Integra LifeSciences CorporationCT scanning, Integra InterFix CT Adapter (CTA)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107363
mdprc 065 03 12 000Cell Marque CorporationIVD, Antibody, Cell Marque CD7http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107190
mdprc 064 03 12 000Beckman Coulter IncIVD, Reagent. ACCESS Ostasehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107395
mdprc 051 03 12 000Ion Genius, Inc.Various muscle stimulation productshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107465
mdprc 050 03 12 000Biomet IncProsthesis, knee, Biomet Signature TKA GDE/MDL SET 04-05http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103533
mdprc 049 03 12 000Biomet IncImpants, knee replacement, OSS AVL Poly Tibial Bushing Sethttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107299
mdprc 048 03 12 000Acclarent IncCatheters, Inspira AIR Balloon Dilation Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107235
mdprc 025 03 12 000Siemens Medical SolutionsRadiologiy, Imgaing, Siemens syngo.plazahttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107379
mdprc 024 03 12 000Philips Medical SystemsInformation Management System, Philips Intellispace Portalhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107164
mdprc 023 03 12 000Medisystems CorpNeedle, Hemodialysis, Fistula Needle Set with MasterGuard Ant-Stick Needle Protector.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107478
mdprc 022 03 12 000Carl Zeiss Meditec IncImaging, Laser. Microimaging Laser-TIRF and DirectFRAPhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102128
mdprc 021 03 12 000B Braun Medical IncInfusion pump, Infusomat Space Pumphttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107007
mdprc 020 03 12 000Kerr CorpDental, Fusio Liquid Dentinhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107638
mdprc 019 03 12 000AngioDynamicsInfusion System, BENEPHIT CVhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107342
mdprc 018 03 12 000BD Diagnostic SystemsReagents, BBL Lysine Iron Agarhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107173
mdprc 185 02 12 000Winco, Inc.Chairs, Premier LifeCare Recliner and Premier Care Reclinerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107175
mdprc 184 02 12 000Varian Medical SystemsRadiation, Standard and Millennium 52-leaf MLC multileaf collimatorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107242
mdprc 183 02 12 000Clarity Medical Systems IncOphthalmic, Imaging. Retcam3 & Retcam Shuttlehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107470
mdprc 182 02 12 000Cardinal HealthSutures, Presource kits assembled with Ethicon Sutures in new Tyvek packaginghttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107172
mdprc 181 02 12 000ThermoFisher ScientificIVD, Oral-Eze (R) Oral Fluid Collection Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106985
mdprc 180 02 12 000Siemens Medical SolutionsRadiation, Therapy. ARTISTE, ONCOR and PRIMUS Linear Accelerators with RT Therapist Workspacehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107337
mdprc 179 02 12 000Lab Vision CorporationIVD, UltraVision Detection Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106997
mdprc 178 02 12 000Greiner Bio-One, IncTubes, Blood Collection. LH Lithium Heparin tubesH:\NCMDR\Recalls\Recalls from ECRI\2012\January\01
mdprc 177 02 12 000Corpak MedSystemsFeeding tube. CORFLO-Ultra Jejunal Tube with CORLOCK-Twoomey Y-Adaptorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107147
mdprc 176 02 12 000Alere San DiegoIVD, immunoassays. Strep A Rapid Test Cassettehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106889
mdprc 165 02 12 000Spacelabs Healthcare IncPatient Monitor, MULTI PARAMETER MONITOR - Spacelabs Ultraview SL Command Module.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106417
mdprc 164 02 12 000Varian Medical Systems4D Integrated Treatment Console (4DITC) TrueBeam Linear Acceleratorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106591
mdprc 163 02 12 000Newport Medical Instruments IncVentilator. Cable, an accessory to the Newport HT50 ventilatorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103824
mdprc 162 02 12 000Life Recovery Systems HDMonitoring of patient temperature, Thermosuithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106096
mdprc 161 02 12 000GE HealthcareImaging, Transfer, Table. GE SIGNA EXCITE MR SURGICAL OPTIONhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106393
mdprc 160 02 12 000Elekta IncRadiation therapy treatment, Elekta Synergy Imaging Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107177
mdprc 159 02 12 000AngioDynamics IncPeripheral access, intravenous therapy. Morpheus Smarthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107343
mdprc 158 02 12 000AGFA Corp.Mobile DR X-Ray , DX-D Imaging Packagehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107178
mdprc 148 02 12 000St. Jude Medical IncTherapy, Cardiac Ablation Generatorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107008
mdprc 147 02 12 000Siemens Medical Solutionssyngo RT Therapist and syngo RT Therapisthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105463
mdprc 143 02 12 000SCC Soft Computerlaboratory information system, SoftMic GUIhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105453
mdprc 142 02 12 000Philips HealthcareFluoroscopy, Radiography. Philips MultiDiagnost Eleva IITVhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106736
mdprc 141 02 12 000MAQUET IncMagnus Hybrid operating table columnshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105069
mdprc 140 02 12 000Linvatec Corp.Surgery, Tissue Resection. ConMed Linvatec Full Radius Resectorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=101116
mdprc 139 02 12 000Kerr CorpDental cement under the brand name Cement-It and Natural Elegancehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105131
mdprc 138 02 12 000Integra LifeSciences CorporationBone void filler, Integra OS Osteoconductive Scaffold Puttyhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106839
mdprc 137 02 12 000Hospira IncSyringes, Sodium Chloride Flush Syringeshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105642
mdprc 136 02 12 000GE HealthcareImaging, GE MR Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104146
mdprc 135 02 12 000Biomet MicrofixationIQ Intelligent Driver , aid in the implantation of screwshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105380
mdprc 134 02 12 000Biomet IncHip and knee joint replacement prostheses , OSS Cemented IM Stemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105423
mdprc 133 02 12 000Toshiba Corp Medical Systems Co LtdX-Ray, Computed Tomography, AQUILION ONEhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107320
mdprc 132 02 12 000Smiths MedicalCADD® High Volume Administration Set, pumpshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106706
mdprc 131 02 12 000Siemens Medical SolutionsPRIMUS and MEVATRON Linear Acceleratorshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106267
mdprc 130 02 12 000Philips Medical SystemsImaging , Positron Emission Tomography, X-ray Computed Tomography. TruFlight Select PET/CT Scanning Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107316
mdprc 129 02 12 000OrthofixManual surgical instrument, Rotating Cutterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107325
mdprc 128 02 12 000Lucero MedicalImpant, ENDURAMESH CORPECTOMY SPACER SYSTEMhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106929
mdprc 127 02 12 000Heritage Labs InternationalCollection Kit, Blood specimen collection, TRIAD brand alcohol padshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105055
mdprc 126 02 12 000GE HealthcareLaboratory, Cabinet x-ray system , CT Scanner, GE eXplore Locus Micro CThttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97538
mdprc 125 02 12 000European Custom Manufacturing B.V.Electrode, pacemaker, temporary. Temporary Pacing Wire, BIPOLARhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106845
mdprc 124 02 12 000Diagnostica StagoIVD, reagents, STA - System Control N+Phttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107052
mdprc 123 02 12 000Bayer HealthcareMonitor, Physiological, Viterion 100 TeleHealth Monitorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106852
mdprc 122 02 12 000Ascension Orthopedics, IncImplant, Joint. First Choice Partial Ulnar Head Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106650
mdprc 119 02 12 000ZOLL Medical CorpDefibrillators , Reduced Energy Multi-Function Electrodes, Zoll pedi.padzhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106605
mdprc 118 02 12 000Wright Medical Technology Inc Joint, DYNASTY Biofoam Shell Prostheseshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106868
mdprc 117 02 12 000Walter Lorenz Surgical, IncLORENZ RESORBABLE DISTRACTOR SYSTEMhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=44812
mdprc 116 02 12 000Sybron Dental SpecialitiesSyringes, Dental, Artiste Flowable and Flow Techttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104069
mdprc 115 02 12 000Stellate SystemsHarmonie Software, electroencephalographic, Monitoring Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=93867
mdprc 114 02 12 000Siemens Medical SolutionsMAMMOMAT Inspiration Full field digital mammographic x-ray systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105375
mdprc 113 02 12 000Siemens Medical Solutionssyngo.plaza Image processing systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105379
mdprc 112 02 12 000Radiometer America IncICD, Crea Calibration solutionhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106824
mdprc 111 02 12 000Kimberly-Clark CorporationTampons, Kotex Natural Balance Security tamponshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105225
mdprc 110 02 12 000Inverness Medical IncIVD, West Nile Virus IgM Capture ELISAhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=76225
mdprc 109 02 12 000DeRoyal Industries IncSurgical kits, TRAUMA CRANIOTOMY PACKhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107151
mdprc 108 02 12 000DePuy International LimitedDePuy Offset Wire Fixation Bolt used in Ace-Fischer External Fixation Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105036
mdprc 107 02 12 000Cytophil, IncDental, Synthetic Grafting Material. Periophil Biphasic, Periobase Biphasic, and Periobone Biphasichttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107165
mdprc 106 02 12 000Cardiopulmonary Instrumentation IncTransporting, Stainless Steel Patient Transport Stretcherhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=101119
mdprc 105 02 12 000BD BiosciencesBD 30G1/2" Precision Glide" Needle Needleshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106993
mdprc 104 02 12 000Advanced Sterilization ProductsSTERRAD NX Sterilizer Hydrogen Peroxide Gas Plasma Sterilizerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=78821
mdprc 083 02 12 000Smith & Nephew incPositioning Aids, SPIDER2 Limb Positionerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105688
mdprc 081 02 12 000Siemens Healthcare DiagnosticsIVD, ADVIA Centaur CA19-9 Assayhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105596
mdprc 080 02 12 000Bausch and Lomb, IncorporatedCrystalens® Accommodating Posterior Chamber Intraocular Lenshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105816
mdprc 079 02 12 000AngioDynamics IncTargeted Renal Therapy Infusion System, Benephit XThttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105887
mdprc 078 02 12 000A-M Systems, IncViroMax viral/bacterial filterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=90493
mdprc 077 02 12 000Terumo Cardiovascular Systems CorporationSurgical, Sarns Sternal Saw Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104231
mdprc 076 02 12 000Terumo Cardiovascular Systems CorporationCDI 101 Hematocrit/Oxygen Saturation Monitoring Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105526
mdprc 075 02 12 000Stryker MedicalBeds, mattress. Stryker EMS Stair-PROhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105384
mdprc 074 02 12 000OssurTotal Knee Junior Prostheseshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=84735
mdprc 073 02 12 000Ortho-Clinical DiagnosticsReagents, Clinical Chemistry, VITROS Chemistry Productshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106485
mdprc 072 02 12 000Midmark CorpSterilizing Units, Midmark M11 Ultra Steam Sterilizerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105922
mdprc 071 02 12 000Maquet Cardiopulmonary AGQUADROX iD PEDIATRIC -OXYGENATORhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106185
mdprc 070 02 12 000Kerr CorporationArtiste Maverick Tinthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105793
mdprc 069 02 12 000DeRoyal Industries IncSurgical DeRoyal Surgical Kits and trayshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106645
mdprc 068 02 12 000Biosense Webster IncDiagnostic/Ablation Catheter, EZ Steer ThermoCool Navhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106361
mdprc 067 02 12 000Biomet Incorthopedic reconstruction, Artificial Ligament Fixation Device, Togglelochttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=72047
mdprc 066 02 12 000Beckman Coulter IncAU Clinical Chemistry Analyzershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106792
mdprc 065 02 12 000Alere LTDAnalyzer, IVD, Alere Cholestech LDX Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105233
mdprc 064 02 12 000Stryker OrthopaedicsVarious Rasp and Broach Handleshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106411
mdprc 063 02 12 000SIEMENSRadiological image processing system, syngo Imaging XShttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105377
mdprc 062 02 12 000Henry Schein, IncMaxcem Elite Refill Kithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105261
mdprc 061 02 12 000Nurse Assist, IncUrethral Catheterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105373
mdprc 060 02 12 000Ascent Healthcare SolutionsSurgery, Arthroscopic shaver blades. DYONICS, STRYKER, LINVATEC Arthroscopic Blades and Burrshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100887
mdprc 046 02 12 000Vital Signs Inc A GE Healthcare CoBroselow/Hinkle Pediatric Emergency Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106353
mdprc 045 02 12 000Varian Medical SystemsTherapy, X-ray collimator, The Varian Millennium Collimatorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107038
mdprc 044 02 12 000Toshiba Corp Medical Systems Co LtdImaging, DRAD-3000E Radrex-i X-ray Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=107036
mdprc 043 02 12 000Kimberly Clark Health CareMIC Gastroenteric Feeding Tubeshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106739
mdprc 042 02 12 000Edwards LifesciencesVigilance II Monitorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=84048
mdprc 041 02 12 000Volcano CorpGuidewire, Volcano FloWire Doppler Guidewirehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106630
mdprc 040 02 12 000Vision-Sciences, Inc.Lithium-Ion Rechargeable Batteries and Battery Chargershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106518
mdprc 039 02 12 000Varian Medical SystemsARIA Radiation Oncologyhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106598
mdprc 038 02 12 000Nemschoff Chairs, Inc.Nemschoff Perinatal Bassinethttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106002
mdprc 037 02 12 000Healthway Home Products, IncAir Purifier devicehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106910
mdprc 036 02 12 000Alphatec Spine IncImplants, Solanas Posterior Stabilization Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104000
mdprc 035 02 12 000Varian Medical SystemsRadiotherapy Systems, 4D Integrated Treatment Console (4DITC)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106587
mdprc 034 02 12 000Stryker Howmedica Osteonics CorpImplants, MEDPOR TITAN Cranial Temporalhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106899
mdprc 033 02 12 000Ortho-Clinical DiagnosticsLaboratory, VITROS Chemistry Products DT Calibrator Kitshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106492
mdprc 032 02 12 000Novomedicus LlcProthesis, The Artificial Bur Prothesishttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106735
mdprc 031 02 12 000Kerr CorpDental cement, Maxcem Elitehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106203
mdprc 030 02 12 000Adenna IncPhantom black latex powder-free gloveshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106728
mdprc 017 02 12 000Zimmer incImplants, non-sterile, Most Option Stem Distractorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105072
mdprc 016 02 12 000Walgreen CompanyWalgreens Quick Read, Digital Thermometerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105927
mdprc 015 02 12 000Stryker InstrumentsSterile ,single use, disposable , Stryker PCD Precision System, Needle with Spineplexhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105884
mdprc 014 02 12 000Ortho-Clinical DiagnosticsLaboratory, enGen(TM) Laboratory Automation Systems configured with Hettich Rotanta 46 RSC Robotic Centrifugeshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106733
mdprc 013 02 12 000Mani IncMANI Needle and Suture Pack PGA Absorbablehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105997
mdprc 012 02 12 000Lin-Zhi International IncIVD, Multi-Analyte Urine DAU Cutoff Calibratorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106374
mdprc 011 02 12 000Gunnell, Inc.Patient transfer, wheelchairs. Gas cylinders used in Gunnell manual wheelchairshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105241
mdprc 010 02 12 000Cincinnati Sub-Zero Products IncProbes, Thermometerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105007
mdprc 009 02 12 000Church & Dwight IncDental, Toothbrush. Spinbrush Prohttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106647
mdprc 008 02 12 000CareFusionCentral programming, monitoring, Alaris PC unithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106751
mdprc 007 02 12 000AngioDynamicsCatheterization Kits, Various Morpheous CT Peripherally Inserted Central Catheter Tray Kitshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106914
mdprc 124 01 12 000Zimmer incImplants, knee prosthesis, Natural-Knee II Durasul All-Poly Patellahttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106657
mdprc 123 01 12 000Terumo Cardiovascular Systems CorporationCDI Blood Parameter Monitoring Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105576
mdprc 122 01 12 000Terumo Cardiovascular Systems CorporationVascular, The Terumo Advanced Perfusion System 1http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105471
mdprc 121 01 12 000Lin-Zhi International IncReagent, Barbiturate Enzyme Immunoassayhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106392
mdprc 120 01 12 000Encore Medical, LpProstheses, Joint, Foundation Hip System Series 460 Hip Stem Prostheseshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103532
mdprc 119 01 12 000Biomet IncImplant, Surgery, SternaLock Blu Implant Trayhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106198
mdprc 118 01 12 000Surgical Appliance IndustriesHelp relieve tired, Truform Therapeutic Classic Medical Style Compression Pantyhose and Stockingshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105382
mdprc 117 01 12 000SIEMENSPicture Archiving and Communication Systems, Syngo plazahttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106410
mdprc 116 01 12 000PENTAX Europe GmbHOptical, monitors. Pentax Video Visualization devices.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106476
mdprc 115 01 12 000Lin-Zhi International IncIVD, Multi-Analyte Urine DAU Controlhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106237
mdprc 114 01 12 000Gulf Medical Fiber optics Inc.Lights, Surgical Headlighthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100769
mdprc 113 01 12 000GE HealthcareScanning Systems, LOGIQ P6 Diagnostic Ultrasound Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106458
mdprc 112 01 12 000Fresenius Medical CareOptiflux Hemodialyzershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106328
mdprc 111 01 12 000Codman & Shurtleff IncNeurosurgical procedures, Codman Cranial Access Kit and Disposable Intracranial Pressure (ICP) Kit, with Xylocainehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105156
mdprc 110 01 12 000Biomet MicrofixationStandard Offset Mandible in the Total Temporomandibular Joint (TMJ) Replacement Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106771
mdprc 106 01 12 000Sechrist Industries IncSechrist Hyperbaric Chamber Gurney.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105498
mdprc 105 01 12 000Salter LabsBubble humidifierhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104930
mdprc 104 01 12 000Navilyst MedicalNAMIC Convienience Kithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106322
mdprc 103 01 12 000Hospira IncHospira Blood Sethttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106687
mdprc 102 01 12 000Cypress Medical ProductsExamination Gloves, Zee Clear Vinyl Medicalhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105791
mdprc 101 01 12 000CovidienDisposable Syringe Fill Tubes, Handi-Filhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106734
mdprc 100 01 12 000CareFusionElectroencephalographs, Microelectrode Amplifiers, Stimulatorshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104816
mdprc 099 01 12 000Allen Medical SystemsSupport a patient's head, Allen C-Flex Head Positionerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105422
mdprc 098 01 12 000AGFA CorpImage Digitization Systems, DX-G Computed Radiography Digitizer Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106055
mdprc 087 01 12 000Teleflex MedicalDermaHood Neuro Elastic Retractorshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105993
mdprc 086 01 12 000Philips HealthcareMulti Diagnost Elevahttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105784
mdprc 085 01 12 000Medtronic IncSpinal System, MULTI-AXIAL SCREWhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105828
mdprc 084 01 12 000Medical Compression SystemsPreventing deep Vein Thrombosis, ActiveCare DVT Medical Compression Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103789
mdprc 083 01 12 000Synthes IncBone Matrix Implants,Norian Skeletal Repair Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104316
mdprc 082 01 12 000EyezoneNeuLook COLOR CONTACT LENSEShttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106091
mdprc 081 01 12 000Baxter HealthcareBaxter Interlink System , General-Purpose.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105971
mdprc 065 01 12 000Varian Medical SystemsPortal Vision (Electronic Portal Image Device) R-Arm with 4D Integrated Treatment Consolehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106201
mdprc 064 01 12 000The Raymond CorporationRaymond Laser alignment guidehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105699
mdprc 063 01 12 000Teco DiagnosticsUrine Reagent Strips (URS) 10 Parametershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105523
mdprc 062 01 12 000OrthoHelix Surgical Design IncMAXLOCK EXTREME EXTREMITY PLATING SYSTEMhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105467
mdprc 061 01 12 000Navilyst MedicalExodus Standard Loop Biliary Drainage Cathetershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106448
mdprc 060 01 12 000Osteotech IncFoil Pouch, Tyvek pouch Fracture repair, Grafton DBM http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104904
mdprc 059 01 12 000Ormco CorpOrthodontic, TMA Archwireshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105877
mdprc 058 01 12 000ICU Medical, IncIV Start Kits, Orbit and Orbit Micro, alcohol prep padshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105695
mdprc 048 01 12 000Philips HealthcareVentilators, Respironics Trilogy 100, 200 and 202http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104431
mdprc 047 01 12 000Innovatech Medical ResourcesRotator cuff repair, bone anchor, suture cartridge, ablation wand Intended, arthroscopic and orthopedic procedureshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104345
mdprc 046 01 12 000IKARIA IncINOmax DS (Delivery System), delivers INOMAX (nitric oxide for inhalation)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104896
mdprc 045 01 12 000SIEMENSSyngo Imaging XS Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105378
mdprc 044 01 12 000Salter LabsETCO2 Divided Sampling Cannula with Simultaneous Oxygen Deliveryhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106145
mdprc 043 01 12 000Oculus Innovative Sciences IncPuracyn OTC Wound & Skin Care Solution, Microcyn Dermatology and HydroGel Sprayhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105228
mdprc 042 01 12 000Endotec IncBeuchal Pappas Mobile Bearing Knee Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104503
mdprc 041 01 12 000Ortho Development CorpEscalade Acetabular Cup System, U-Joint Hex Head Driverhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106309
mdprc 040 01 12 000Integra LifeSciences CorporationCatheters, Ventricular. Cranial Access Kits with Xylocainehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106499
mdprc 039 01 12 000Impact Instrumentation, IncMRI Reusable/Disposable Circuithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106429
mdprc 038 01 12 000ConMed Linvatec CorporationR2 Adult Zoll Non-Radiolucent Multifunction Electrodeshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106249
mdprc 037 01 12 000AngioDynamicsHemodialysis and Apheresis, Catheter Set, DuraMax®http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106537
mdprc 036 01 12 000Varian Medical SystemsRadiotherapy treatments, Varian brand Eclipse, Treatment Planning Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106612
mdprc 035 01 12 000Space labs Healthcare IncCardio Express SL6 ECG cablehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106510
mdprc 034 01 12 000LINETLinet Remote Handset, bedhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106652
mdprc 033 01 12 000Care FusionMedical Device Data System, NicVue Softwarehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106489
mdprc 032 01 12 000Baxter HealthcareInfusion Pump, Colleague CX and 3 Volumetric,http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=105691
mdprc 031 01 12 000Advanced Sterilization ProductsHydrogen Peroxide Gas Plasma Sterilizer, STERRAD® 200 Sterilizerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=106716
mdprc 022 12 11 000Zimmer incZMR Porous Revision Hip Prosthesis and ZMR Revision Taper Hip ProsthesisFDA
mdprc 021 12 11 000Varian Medical SystemsRadioterapy, accelerator, Head Ring Posts; of the Optical Guidance Platform and Floorstand devicesFDA
mdprc 020 12 11 000Varian Medical SystemsRadiation therapy, Varian brand GammaMed 12i AccessoryFDA
mdprc 019 12 11 000Varian Medical SystemsRadiotherapy, TrueBeam and TrueBeam STxFDA
mdprc 018 12 11 000Synthes IncSynthes Oscillating Saw Attachment/Large w/Key for Small Battery DriveFDA
mdprc 017 12 11 000SCC Soft ComputerSoftware, SoftPath GUI Versions: 4.3.0.10, 4.3.0.11, and 4.3.0.12.FDA
mdprc 016 12 11 000RaySearch Laboratories ABRadiationtherapy, RayStationFDA
mdprc 015 12 11 000Radiometer America IncMonitor, Non-invasive, transcutaneous pCO2 electrodesFDA
mdprc 014 12 11 000Nanotherapeutics, IncOrigen DBM with Bioactive GlassFDA
mdprc 013 12 11 000MAQUET IncVentilator, Servo-I & Servo-S ventilator systemFDA
mdprc 012 12 11 000Elekta IncRadioterapy, XVI R4.5 X-ray Volume Imaging SystemFDA
mdprc 011 12 11 000Boston Scientific Cardiac Rhythm Management GroupPulse generator, defibrillator, Programmer, LATITUDE® Patient Management SystemFDA
mdprc 010 12 11 000Bard Pcripheral Vascular (BPV)The EnCor® biopsy probe, designed for use with EnCor® and EnCor® Enspire Vacuum Assisted Biopsy (VAB) driver systems.FDA
mdprc 009 12 11 000Acute Innovations LlcScrew, RibLoc Rib Fracture Plating System, Standard ScrewFDA
mdprc 008 12 11 000Toshiba Corp Medical Systems Co LtdRadiation, Catheterization Table, a component of the Toshiba INFX-8000 series X-Ray Interventional System.FDA
mdprc 007 12 11 000Philips HealthcareDigital, a radiographic system, Philips Digital Diagnost Rel 3FDA
mdprc 006 12 11 000Elekta IncRadiotherapy, Stereotactic Circular CollimatorFDA
mdprc 005 12 11 000Atom Medical CorpIncubator, Rabee Incu iFDA
mdprc 004 12 11 000Arrow International IncArrow International StimuCath(R) Continuous Nerve Block KitFDA
mdprc 121 11 11 000Terumo Cardiovascular Systems CorporationPerfusion, Sarns Modular Perfusion System 8000, Circuit Board for MBattery ModuleFDA
mdprc 120 11 11 000Terumo Cardiovascular Systems CorporationPerfusion, Advanced Perfusion System 1FDA
mdprc 119 11 11 000Acrymed IncorporatedDressing, ON-Q Silver DressingFDA
mdprc 118 11 11 000Philips HealthcareRadiation, Magnetic Resonance Systems, Ingenia 1.5T and 3.0T MRI Systems.FDA
mdprc 117 11 11 000Pelstar, LlcDigital patient weighing scale, Health o Meter Professional Remote Display Digital Physician ScaleFDA
mdprc 116 11 11 000Microgenics CorpCalibrators, Multigent Vancomycin CalibratorsFDA
mdprc 101 11 11 000SIEMENSRadiation, (Single-Photon Emission Computed Tomography and Computed Tomography) System, Symbia T & S Series SPECT-CT SystemFDA
mdprc 100 11 11 000SCC Soft Computersoftware, laboratory, SoftlabFDA
mdprc 099 11 11 000SCC Soft Computersoftware, laboratory, SoftLab GUIFDA
mdprc 098 11 11 000International Biophysics CorpBlood, open heart procedures, suction, IBC Suction WandFDA
mdprc 097 11 11 000Immunetech IncNon-sterile alcohol prep pads, MyAllergyTest, Specimen Collection KitFDA
mdprc 096 11 11 000Hospira IncAdminister fluids, Hospira LifeShield Latex-Free 150 mL Burette SetB.FDA
mdprc 095 11 11 000AGFA Corp.Software used to IMPAX CardioVascular (CV) Admin Tool, AdminTool2FDA
mdprc 088 11 11 000GE HealthcareNeedle, radiotherapy, RAPID Strand Rx kitSource FDA
mdprc 087 11 11 000Uplift Technologies Inc.Chair, Lifting commode chair, Uplift Commode AssistFDA
mdprc 086 11 11 000Stryker EndoscopyStryker Endoscopy 3.55 MM Super 90 S-SERFAS Energy Probe; electrosurgical deviceFDA
mdprc 085 11 11 000Philips Medical SystemsRadiation, Gamma Camera ,SKYLight Gamma Camera SystemFDA
mdprc 084 11 11 000Boston Scientific Cardiovascular GroupVasculature, Introducer Sheaths, Boston Scientific Super Sheath and Super Sheath R/O Introducer SheathsFDA
mdprc 083 11 11 000SCC Soft ComputerSoftware, SoftLabFDA
mdprc 082 11 11 000C P MedicalSynthetic Absorbable Suture, Mono-Dox Synthetic Absorbable SutureFDA
mdprc 081 11 11 000AGFA Corp.Software, Reporting Module, IMPAX Cardiovascular Results Management (RM)FDA
mdprc 080 11 11 000Cyberonics IncStimulators, VNS Therapy Aspire HC Generator and VNSFDA
mdprc 079 11 11 000AGFA Corp.Echo Measurement Import via Optical Character Recognition (OCR), IMPAX CVFDA
mdprc 078 11 11 000SCC Soft ComputerSoftware, SoftPath GUIFDA
mdprc 077 11 11 000Meridian Bioscience IncPremier Enterohemorrhagic test kit (EHEC), Reagent KitsFDA
mdprc 076 11 11 000Lifewatch Services IncCardiac, sensor, Ambulatory Cardiac Telemetry, LifeStar ACT III Platinum Sensor, LifeStar ACT I Sensor, ACT Cellular Phone MonitorFDA
mdprc 075 11 11 000Medtronic MiniMedInfusion system, infusion pump, paradigm mio Infusion SetsFDA
mdprc 074 11 11 000Cordis CorporationRadiation, Angiographic, catheter, SUPER TORQUE MB Angiographic CatheterFDA
mdprc 073 11 11 000Physio Control IncDefibrillator, LIFEPAK 20FDA
mdprc 072 11 11 000Stryker OrthopaedicsProstheses, Restoration ADMFDA
mdprc 071 11 11 000Alere San DiegoPrep Pads, PDI Alcohol Prep Pads packaged in the INRatio kitFDA
mdprc 070 11 11 000Pentron Clinical Technologies LLCAdhesive Resin Cementhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104859
mdprc 069 11 11 000Invacare CorporationBeds, Invacare bariatric bedhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102837
mdprc 068 11 11 000Greiner Bio-One IncTube, Blood collection, Vacuette tube, Vacuette 4ml EDTA DK2 tubehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103999
mdprc 067 11 11 000Albahealth LLCAnti-Embolism Wrap System, Pulstar(R) DVT PREVENTION SYSTEMhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104473
mdprc 055 11 11 000Philips Medical SystemsExtended Brilliance Workstation-NM (EBW-NM)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104283
mdprc 054 11 11 000King InternationalShoulder Flex Massage Devicehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103827
mdprc 053 11 11 000Greiner Bio-One IncVACUETTE Blood Collection, Quick Shield with Snappy Safety Holderhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103997
mdprc 052 11 11 000Capintec IncCapintec CRC 25 PET, dose calibratorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102757
mdprc 046 11 11 000Synthes IncSpine T-PAL Spacer System.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104221
mdprc 045 11 11 000Medtronic Inc Cardiac Rhythm Disease Management DivCryoCath Arctic Front CryoAblation Catheterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104277
mdprc 044 11 11 000Medrad IncStellant Sterile Disposable Syringe Kitshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104852
mdprc 043 11 11 000Biopro, IncOrthopedic femoral headhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104523
mdprc 042 11 11 000Becton Dickinson & Co. (BD)Blister packaged insulin syringehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104880
mdprc 041 11 11 000AMO Manufacturing USA, LLCIntraLase Femtosecond Laser Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104854
mdprc 025 11 11 000Terumo Cardiovascular Systems CorporationCDI 500 Monitorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103146
mdprc 024 11 11 000Picis IncPicis Anesthesia Managerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104224
mdprc 023 11 11 000Merz Aesthetics, IncInjectable Implant, Radiesse® Volumehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104304
mdprc 022 11 11 000MAKO Surgical CorpRIO Robot Arm Interactive Orthopedic Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98566
mdprc 021 11 11 000Davol, IncBard® Ventralex" ST Medium Circle with Strap Hernia Patchhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104352
mdprc 020 11 11 000Bioplate IncBioplate Titanium Fixation System, Sterile Kithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=91084
mdprc 088 10 11 000Sierra Scientific Instruments IncVisualization System (MVS), AR ManoShieldhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104678
mdprc 087 10 11 000Salter LabsMask adult, oxygenhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99388
mdprc 086 10 11 000Mizuho OSIModular Orthopedic Surgical Table Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103036
mdprc 085 10 11 000Lifeline First Aid LLCMountain, ARC DISASTER, Base Camp, Highlands, Wilderness, First Aid Kithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104291
mdprc 084 10 11 000GE HealthcareMagnetic Resonance Imaging, MSK Extreme 1.5T Scanning Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103010
mdprc 083 10 11 000GE HealthcareRadiographic Systems, Digital, Senographe DS Full and Senographe Essential Mammography Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102282
mdprc 082 10 11 000CareFusionPortable critical care, EnVe Ventilatorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104017
mdprc 081 10 11 000Beckman Coulter IncBiological fluid, SYNCHRONhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=101427
mdprc 080 10 11 000Baxter HealthcareBaxter Flo-Gard 6301 Volumetric, Infusion Pumphttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104641
mdprc 079 10 11 000Corpak MedSystemsCORFLO 300 Enteral Pumphttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104131
mdprc 078 10 11 000Carl Zeiss Meditec IncOPMI VARIO 700, Surgical Microscopehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104239
mdprc 064 10 11 000The Anspach Effort, Inc.Sterile Bone Cutting Burrshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104176
mdprc 063 10 11 000Siemens Healthcare Diagnostics GmbHDimension(R) EXL Cardiac Troponin I Flex(R) Reagent Cartridgeshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103939
mdprc 062 10 11 000Medtronic Perfusion SystemsMedtronic Disposable Pressure Display Set and Boxhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104227
mdprc 061 10 11 000Biomet IncMICROPLASTY TAPERLOC 7.5 MM RESECTION GUIDEhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103982
mdprc 058 10 11 000Wright Medical Technology IncAnchor Lok, Soft Tissue Anchor Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104210
mdprc 050 10 11 000Terumo Cardiovascular Systems CorporationTubing, Suction , Sarns Intracardiac, Sarns Rigid Intracardiac Suckershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103985
mdprc 044 10 11 000Worldwide Medical TechnologiesProstate Seeding Needle, Applicator Techniquehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103394
mdprc 043 10 11 000Siemens Healthcare Diagnostics Dimension(R) EXL LOCI Cardiac Troponin I Calibratorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103938
mdprc 042 10 11 000Richard-Allan ScientificRotary Microtome, Thermo Scientific Micromhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102246
mdprc 041 10 11 000Interventional Spine IncBONE-LOK PLS System, PERPOS Driver and PERPOS PLS Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99402
mdprc 040 10 11 000Edan Instruments IncSE-1, SE-3 and SE-601 series, ECG Cablehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103882
mdprc 039 10 11 000Cooper VisionSoft Contact Lenses, AVAIRA ToricZ-0044-2012
mdprc 026 10 11 000Accuray IncRadiation Therapy, CyberKnife Robotic Radiosurgery Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104019
mdprc 011 10 11 000Siemens Healthcare DiagnosticsVitro diagnostic , Dimension Vista® Cuvetteshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103543
mdprc 010 10 11 000Philips HealthcareRadiology, MDC Picture and Archiving Communication Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103870
mdprc 009 10 11 000Biomet MicrofixationLatex Free Rubber Bandhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104047
mdprc 005 10 11 000Cyberonics IncVNS Therapy Demipulse Duo Generatorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=101368
mdprc 004 10 11 000Medtronic Navigation IncRight and Left Long Tactile Probehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97591
mdprc 003 10 11 000B Braun Medical IncOutlook ES Safety Infusion Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103856
mdprc 002 10 11 000Respironics NovametrixPhilips, non-invasive monitoringhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102224
mdprc 001 10 11 000Hospira IncInfusion Pumps, Plum A+,A+3 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=104074
mdprc 073 09 11 000Invacare CorporationWalkers, wheeled adult and junior walkershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99590
mdprc 072 09 11 000GE HealthcareRadiation, Software, ADVANTAGE WINDOWS (Workstation) WITH FUNCTOOL OPTIONhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103023
mdprc 069 09 11 000Picis IncSoftware, CareSuitehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=86830
mdprc 068 09 11 000Baxter HealthcareLogix Order Entry (OE) Softwarehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103498
mdprc 067 09 11 000AngioDynamics IncSurgical ,Nanoknifehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103817
mdprc 059 09 11 000Cardiac Science CorporationPowerheart automated external defibrillatorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102214
mdprc 058 09 11 000AngioDynamics IncUNI*FUSE, INFUSION SYSTEMhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103807
mdprc 054 09 11 000Varian Medical SystemsTreatment Console, 4D Integratedhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103151
mdprc 053 09 11 000Terumo Cardiovascular Systems CorporationCardioplegia Monitorshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103024
mdprc 052 09 11 000Pride Mobility Products LtdMobility medical devicehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103748
mdprc 051 09 11 000Philips HealthcareRadiological Image Processing System , PCR Eleva http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102849
mdprc 050 09 11 000Philips HealthcareBrilliance Computed Tomography Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103270
mdprc 049 09 11 000Becton Dickinson & Co. (BD)DNA. RNA,GBS, BD MAX Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103132
mdprc 048 09 11 000AngioDynamicsAngiographic Catheter, Soft-Vuhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103751
mdprc 046 09 11 000The Anspach Effort, Inc.Single Use, Sterile, Bone Cutting Burrshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=101551
mdprc 045 09 11 000Philips Medical SystemsDiagnostic Imaging Systems, Philips GEMINIhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=101505
mdprc 044 09 11 000Hamamatsu CorporationX-ray system, Micro Focus X-Ray generatorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103604
mdprc 035 09 11 000TiSportTiLite ZR Series 2 and ZRA Series 2, Wheelchairshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102216
mdprc 034 09 11 000Terumo Cardiovascular Systems CorporationLevel Detect II Mount Padshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102829
mdprc 033 09 11 000OrthofixRatcheting Torque Limiting Handleshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99424
mdprc 032 09 11 000CovidienLoading Units, DUET TRShttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103762
mdprc 031 09 11 000C P MedicalNon-Absorbable Suture, Monomidhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103603
mdprc 021 09 11 000Varian Medical SystemsTrilogy Mx, On-Board Imager (OBI)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102071
mdprc 020 09 11 000Varian Medical Systems Varian Treatmenthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103135
mdprc 019 09 11 000Steris CorpLiquid Chemical Sterilant Processing Systems, System 1Ehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103574
mdprc 018 09 11 000Steris CorpWasher/Disinfectors, Reliance Vision and Single Chamberhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103262
mdprc 016 09 11 000Accuray IncHi-Art System, TomoTherapyhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102795
mdprc 087 08 11 000Encision IncSuction Irrigation Electrodes, Encision AEMhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103728
mdprc 086 08 11 000Covidien LtdGenerator, Coagulation, Evident MWAhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103590
mdprc 085 08 11 000Varian Medical SystemsRadiation Therapy, 4D Integrated Treatment Console (4DITC)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102343
mdprc 084 08 11 000Applied Medical ResourcesOptical Access System, trocars, Kiihttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103070
mdprc 083 08 11 000Arjo HuntleighAssistive Equipments, Entroy Pool Lifthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103152
mdprc 082 08 11 000GE Medical SystemsDASH Patient Monitorshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99459
mdprc 080 08 11 000Sysmex America IncAutomated Hematology Analyzershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103015
mdprc 073 08 11 000Alliant Enterprises LLCAdjustable Vent Valve, TruChoice and 3-T Medical systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103026
mdprc 071 08 11 000Varian Medical Systems.High-Definition 120 Multileaf Collimator.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=101854
mdprc 070 08 11 000Steris CorpIndicator Strips and Challenge Pack, Verify® SixCesshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103396
mdprc 069 08 11 000Draeger Medical IncPortable Patient Monitor, Infinity Gamma X XL and Delta.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=103117
mdprc 068 08 11 000Bio-Rad Laboratories IncEnzyme, Reagents, Kallestad Mouse Stomach/Kidney (MSK) Test Kithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=93068
mdprc 063 08 11 000Mckesson Information Solutions LLCHorizon Medical Imaginghttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102413
mdprc 062 08 11 000Steris CorpLow Temperature Sterilization Systems, Amsco V-PRO 1 and Amsco V-PRO 1 Plushttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102995
mdprc 061 08 11 000Spacelabs Healthcare IncPortable patient monitor with arrhythmia detection or alarmshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=94553
mdprc 059 08 11 000Siemens Healthcare DiagnosticsIVDs, Dimension Calcium Flex Reagenthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102582
mdprc 045 08 11 000Varian Medical SystemsEclipse Treatment Planning System http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102598
mdprc 044 08 11 000Beckman Coulter IncAccess Immunoassay Systems, Unconjugated Estriolhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=101912
mdprc 043 08 11 000SIEMENSLinear Accelerator, ARTISTEhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=101290
mdprc 042 08 11 000Elekta/IMPACLANTIS Oncology Information Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102338
mdprc 041 08 11 000Varian Medical SystemsClinac, Trilogy Tx and Novalis Tx Linear Acceleratorshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=101078
mdprc 040 08 11 000Varian Medical SystemsNeedles, Plastic Needles with Mandrin Guideshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102637
mdprc 039 08 11 000Varian Medical SystemsTitanium Intrauterine Probeshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102647
mdprc 038 08 11 000Varian Medical SystemsFlexible Applicator Probeshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102571
mdprc 037 08 11 000Teledyne InstrumentsMicro-Fuel Cell Oxygen Sensor, Class RI5http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98984
mdprc 036 08 11 000Applied Medical ResourcesSurgical Clamp Insertshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102721
mdprc 035 08 11 000Hologic IncFluoroscan Mini C-armhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102624
mdprc 034 08 11 000Stryker MedicalEMS Stair - Pro Evacuation and Evacuation Stryker Chairs.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=101240
mdprc 033 08 11 000GE HealthcareSeno Advantage Workstationshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100969
mdprc 032 08 11 000Animas CorporationAnimas Insulin Infusion Pumphttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102988
mdprc 031 08 11 000Sunrise MedicalDeVilbiss Heated Humidifierhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100885
mdprc 030 08 11 000Siemens Medical SolutionsRadiation Therapy Pallethttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100609
mdprc 020 08 11 000Teleflex MedicalCatheters, Rusch Femalehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102359
mdprc 019 08 11 000Boston Scientific CorporationPinnacle Pelvic Floor Repair Kit (Anterior), Apical and Pinnacle Pelvic Floor Repair Kit (Posterior)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100416
mdprc 018 08 11 000Welch Allyn Protocol IncWireless Network Access Points, Aruba Model 65http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100762
mdprc 017 08 11 000Cardiac Science CorporationDefibrillator, Powerheart AED, G2http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102212
mdprc 016 08 11 000Spectranetics CorporationLaser Guide Catheter, Spectranetics Turbo-Booster Laser Guide Catheterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102450
mdprc 015 08 11 000Philips Medical SystemsBrightView XCT and X Gamma Camerahttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102054
mdprc 014 08 11 000Haemonetics CorpCardiovascular Perioperative Autotransfusion System, Haemonetics cardioPAThttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102445
mdprc 013 08 11 000Biomet IncProsthesishttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100968
mdprc 004 08 11 000Spacelabs Healthcare IncVital Sign elance Monitorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102807
mdprc 003 08 11 000Philips HealthcareComputer tomography systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=101749
mdprc 002 08 11 000Biomet MicrofixationSYSTEM SCREWDRIVER BLADEhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100613
mdprc 112 07 11 000Salient Surgical Technologies IncElectrosurgical Unitshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102436
mdprc 111 07 11 000I-FlowInfusion Pumpshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=101372
mdprc 110 07 11 000Vital Signs Inc A GE Healthcare CoVital Signs Passive Humidification Deviceshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100921
mdprc 109 07 11 000Toshiba Corp Medical Systems Co LtdAplio Ultrasound Diagnostic System.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97589
mdprc 108 07 11 000Global Focus Marketing & DevelopSilencer Centrifugeshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102133
mdprc 107 07 11 000Varian Medical SystemsRadiation Therapy, Varian Clinac Linear Acceleratorshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=101083
mdprc 106 07 11 000Cincinnati Sub-Zero Products IncWarming Devicehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100848
mdprc 093 07 11 000Beckman Coulter IncIVD, Radioimmunoassay, Reagents, DHEA RIA Reagenthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97871
mdprc 092 07 11 000MADRImedSaws, Surgical, Reciprocating Saw Attachmentshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=101341
mdprc 091 07 11 000Stryker MedicalStretchers, Stryker Medical Stretchershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102120
mdprc 090 07 11 000Medrad IncFluid Management Injection System, MEDRAD Avantahttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=101479
mdprc 089 07 11 000Philips Medical SystemsGamma Camera System, Philips brand Bright View.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=101026
mdprc 088 07 11 000Biomet MicrofixationInternal Fixation Screws, THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREWhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100808
mdprc 087 07 11 000CovidienRadiation, Angiographic or CT, Syringes, Angiomat Illumena Syringe, 150mL Linden Luer Syringe with Handi-Fil Strawhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=101150
mdprc 076 07 11 000Biomet MicrofixationArthroscopy, Procedure and Arthrosimplicity Kits, TMJ SYSTEM On Point SCOPE PROCEDURE KIThttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102093
mdprc 067 07 11 000CovidienNo absorbable Sutures,(SOFSILK, SURGILON, and TI•CRON )http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=101183
mdprc 066 07 11 000Boston Scientific CorporationVarious Tracheo bronchial Endoprosthesis Stentshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=101124
mdprc 065 07 11 000Sysmex America IncHematology, Automated Analyzers, lytic reagent, Sysmex Stromatolyser-IM (SIM-220A)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100607
mdprc 064 07 11 000Lifescan Johnson & JohnsonOneTouch Delica Lancinghttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=101053
mdprc 063 07 11 000Dental Equipment LLCDental, Dental Light, LuxStarhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=101128
mdprc 062 07 11 000Cincinnati Sub-Zero Products IncConvective Warming Devices, WarmAirhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100840
mdprc 061 07 11 000Baxter HealthcareCatheter, Catheter Extension, Baxter Interlink System Non-DEHP I.V. Catheter Extension Sethttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102086
mdprc 050 07 11 000Vitrolife, Inc.Perfusion, Perfadex with THAM, XVIVO Perfusion ABhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100378
mdprc 049 07 11 000Teleflex MedicalHumidifier Adapters,(Hudson RCI)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100876
mdprc 048 07 11 000Varian Medical SystemsRadiotherapy, Linear Accelerators, Clinac iX, 23EX, CX, DHXC, Novalis Tx, Trilogy and TrueBeam Linearhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100743
mdprc 047 07 11 000Varian Medical SystemsRadiotherapy, Treatment Planning System, Eclipsehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100818
mdprc 046 07 11 000SIEMENSLinear Accelerator systems, ONCOR/PRIMUS Linear Accelerator systems with RTT v2.x AND an ARTISTE Linear Accelerator/RT Therapisthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100961
mdprc 045 07 11 000Medtronic Navigation IncPACS, StealthStation systems, DICOM Query/Retrieve, Sofrware Kithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=88795
mdprc 044 07 11 000Beckman Coulter IncAnalyzers, Clinical Systems, Integrated Workstation, UniCel DxC 880i, 860i,680i and 660i Synchron Access Clinical Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=90200
mdprc 043 07 11 000Bard Access SystemsCatheters, Cuffed central venous catheterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=101247
mdprc 042 07 11 000Ethicon IncVarious Drain Productshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100045
mdprc 041 07 11 000Philips Medical SystemsImaging, PercuNav and Tool Connection Unithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100799
mdprc 040 07 11 000Zimmer incDriver/Extractorshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99671
mdprc 039 07 11 000Terumo Cardiovascular Systems CorporationAdvanced Perfusion System 1 Baseshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99575
mdprc 038 07 11 000Haemonetics CorpAnalyzer System, Thrombelastograph Hemostasis, TEG Hemostasis System Level II Control: Biological Quality Control Level II Kithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100407
mdprc 037 07 11 000DJO SurgicalReverse Shoulder Prosthesis Socket Shellshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99595
mdprc 036 07 11 000Cambridge Endoscopic Devices, IncEndoscopic, Scissors, Cambridge Endoscopic Autonomy Laparo-Angle 5mm Metzenbaum Scissors with Monopolar Cauteryhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100610
mdprc 035 07 11 000BARRX Medical IncULTRA Ablation Catheters(HALO90 )http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100503
mdprc 034 07 11 000Kapp Surgical Instrument IncX-ray, Target Ring, Bariatric Target Ring (Nitinol)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100856
mdprc 033 07 11 000AMS USARepair System, Elevate Anterior and Apical Prolapse Repair Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100412
mdprc 032 07 11 000Varian Medical SystemsRadiotherapy, Linear Accelerators, Trilogy Mx or TrueBeam Radiotherapy Delivery Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100785
mdprc 031 07 11 000Varian Medical SystemsRadiosurgery, Linear Accelerator, Varian High Energy Linear Acceleratorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100758
mdprc 030 07 11 000Varian Medical SystemsRadiation, Oncology, Image Database, ARIAhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100749
mdprc 029 07 11 000Beckman Coulter IncIVDs, Reagnet, Immunoassay, Active Cortisol Enzyme Immunoassay (EIA) kithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=90374
mdprc 016 07 11 000St. Jude Medical IncMonitor, Diagnosis, Implantable Cardiac Monitor (ICM), SJM Confirmhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99926
mdprc 013 07 11 000SCC Soft ComputerSoftware, Soft Reportshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=94634
mdprc 012 07 11 000Ventana Medical Systems IncReagents, iVIEW and ultraView Universal DAB Detection Kitshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100423
mdprc 011 07 11 000Cincinnati Sub-Zero Products IncWarming/Cooling Unitshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100747
mdprc 010 07 11 000Varian Medical SystemsRadiation Treatment Planning System, Eclipsehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100394
mdprc 009 07 11 000Staar Surgical Co.Ophthalmic, Lens, STAAR Surgical Collamer Ultraviolet-Absorbing Posterior Chamber Singlehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100868
mdprc 008 07 11 000Codman & Shurtleff IncENTERPRISE Vascular Reconstruction Device and Delivery Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98486
mdprc 007 07 11 000Teleflex MedicalCrystalClear Tracheostomy Tube Cuffed, Sterile Pack;http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99651
mdprc 006 07 11 000Pall Life SciencesInfusion pumps, Admixture Filter, Pall "TNA1" Total Nutrient Admixture Filterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=101496
mdprc 005 07 11 000ConMed Linvatec CorporationShoulder Restoration System, CrossFT Suture Anchor with Two 2 Hi-Fi Sutureshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100643
mdprc 004 07 11 000Baxter HealthcareInfusion Pumps, Baxter Solution Sethttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100585
mdprc 122 06 11 000VBM Medical IncVentilation Catheters, 14 G Jethttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100370
mdprc 121 06 11 000Terumo Cardiovascular Systems CorporationCDI Blood Parameter Monitoring Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100193
mdprc 120 06 11 000MedcompTitan Hemodialysis Catheterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100757
mdprc 112 06 11 000Biosense Webster Inc.Various Electrode Catheters with Auto ID Technologyhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100470
mdprc 110 06 11 000Becton Dickinson & Co. (BD)IVDs, System Software, BACTEC" FX Instrumenthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100454
mdprc 109 06 11 000Siemens Medical SolutionsCamera imaging system, Linear accelerator systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100356
mdprc 108 06 11 000Beckman Coulter IncLaboratory, Analyzers, Clinical Chemistry, Beckman Unicel DxC 600 and DxC 800 Clinical Systems, Mixer/Washhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=90458
mdprc 107 06 11 000MAQUET IncVentilator Systems, SERVO-i and SERVO-shttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100306
mdprc 106 06 11 000BD BiosciencesProbeTec Chlamydia trachomatis and Neisseria gonorrhoeae Amplification Control Reagent Packshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100457
mdprc 105 06 11 000CMS Inc Div Elekta ABRadiation Treatment Planning System, Interplanthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98759
mdprc 104 06 11 000Arcadia Medical CorporationRespiratory, Tracheostomy Tube, Silicone CTShttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100382
mdprc 103 06 11 000Vital Signs Inc A GE Healthcare CoPressure Infusors, Infusable and Infusa Scanhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99352
mdprc 102 06 11 000Biomet IncProsthesis, Discovery Elbow System with Humeral Condylehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100452
mdprc 101 06 11 000Alere LTDAlcohol Prep Pads, Triadhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100988
mdprc 100 06 11 000Vital Signs Inc A GE Healthcare CoCuffable Blood Pressure Cuffshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100421
mdprc 099 06 11 000Terumo Cardiovascular Systems CorporationPressure Monitoring Kithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100579
mdprc 098 06 11 000StrykerVarious Instrument Sterilization Trayshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=101010
mdprc 097 06 11 000Spacelabs Healthcare IncAnalyzer, Programmable Diagnostic Computer, Pathfinder Holter Analyzerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100815
mdprc 096 06 11 000Integrated Orbital Implants IncImplant, Eye Sphere Wrap, Coated Bio-Eye Orbital Implant with Conformer.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100459
mdprc 082 06 11 000Becton Dickinson & Co. (BD)Laboratory, OXACILLIN SCREEN AGAR, BBL"http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100500
mdprc 080 06 11 000Leica Microsystems Inc.IVDs, Rapid Tissue Processor, Peloris IIhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99479
mdprc 079 06 11 000CMS Inc Div Elekta ABRadiation Treatment Planning System, Focal http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98807
mdprc 078 06 11 000CMS Inc Div Elekta ABRadiation Treatment Planning System, XiO http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98844
mdprc 077 06 11 000CMS Inc Div Elekta ABRadiation Treatment Planning System, Focalhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98843
mdprc 075 06 11 000CMS Inc Div Elekta ABRadiation Treatment Planning System, Focalhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98822
mdprc 074 06 11 000Roche Diagnostics CorpCOBAS AmpliPrep/COBAS TaqMan Hepatitis(Reagents)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100296
mdprc 073 06 11 000Kinamed IncPlate System Driver, SuperCable ScrewDriverhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100337
mdprc 072 06 11 000Integra LifeSciences CorporationCUSA NXT Ultrasonic Tissue Ablation Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100406
mdprc 071 06 11 000CMS Inc Div Elekta ABRadiation Treatment Planning System, XiOhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97479
mdprc 070 06 11 000Boston Scientific CorporationStent System, Innova Self-Expanding Stent Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100508
mdprc 069 06 11 000Mettler Electronics CorpDecompression System, Mettler Traction, MTD 4000http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100298
mdprc 068 06 11 000CMS Inc Div Elekta ABRadiation Treatment Planning System, XiOhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98677
mdprc 067 06 11 000CMS Inc Div Elekta ABXiO RTP System http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98664
mdprc 066 06 11 000CMS Inc Div Elekta ABXiO Radiation treatment Planning System http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98665
mdprc 065 06 11 000CMS Inc Div Elekta ABFocal Radiation Treatment Planning Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98778
mdprc 064 06 11 000CMS Inc Div Elekta ABXiO RTP Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98683
mdprc 063 06 11 000CMS Inc Div Elekta ABXiO Radiation Treatment Planning Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98684
mdprc 062 06 11 000CMS Inc Div Elekta ABXiO RTP Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98753
mdprc 061 06 11 000CMS Inc Div Elekta ABMonaco Radiation Treatment Planning Workstation.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97545
mdprc 059 06 11 000Opti Medical Systems IncOPTI LION E-Plus Cassettehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98847
mdprc 058 06 11 000GE HealthcareGE Centricity Laboratory Instrument Interface Data Innovations Instrument Manager Softwarehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99879
mdprc 057 06 11 000Datascope CorpIntra-Aortic Balloon Pumphttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99835
mdprc 056 06 11 000CMS Inc Div Elekta ABMonaco Radiation Treatment Planning Workstationhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97342
mdprc 055 06 11 000CMS Inc Div Elekta ABFocal Radiation Treatment Planning Workstationhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97560
mdprc 054 06 11 000CMS Inc Div Elekta ABFocal Radiation Treatment Planning Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98748
mdprc 053 06 11 000CMS Inc Div Elekta ABMonaco RTP Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98760
mdprc 052 06 11 000CMS Inc Div Elekta ABMonaco Radiation Treatment Planning Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98825
mdprc 037 06 11 000Biomet IncPorous Plasma Spray (PPS), Regenerex, Regenerex (TM) Ringloc Acetabular Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99961
mdprc 036 06 11 000Biomet IncProstheses, Comprehensive, Bio-modular, bi-angular Reverse Shoulder Humeral Trayshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99606
mdprc 035 06 11 000Newport Medical Instruments IncNewport e360 Ventilatorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99720
mdprc 034 06 11 000Boston Scientific CorporationAtlantis, iCross SR Pro 2, 40 MHz Coronary Imaging Catheterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100636
mdprc 033 06 11 000AGFA CorpCardio Review Station (CRS)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98834
mdprc 014 06 11 000Newport Medical Instruments IncNewport HT70 Ventilatorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99719
mdprc 012 06 11 000Linet spol. s r.o.Eleganza 3 Hospital Bedhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=100295
mdprc 010 06 11 000CMS Inc Div Elekta ABXiO Radiation Treatment Planning Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98670
mdprc 008 06 11 000CMS Inc Div Elekta ABXiO Radiation Treatment Planning Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98841
mdprc 006 06 11 000Capsule Tech IncCapsule Neuron UMPChttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99753
mdprc 005 06 11 000Alere LTDCholestech Profile GLU Test Cassetteshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99591
mdprc 001 06 11 000Encision IncAEM Disposable Scissorshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99521
mdprc 098 05 11 000ZOLL Medical CorpZoll E Series BLS Defibrillator/Pacemaker/Monitorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99664
mdprc 097 05 11 000Wavelight AGWaveLight Femtosecond Laser Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99665
mdprc 096 05 11 000Nurse Assist, IncVarious urological catheter trayshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98850
mdprc 095 05 11 000Newport Medical Instruments IncNewport HT50 Ventilatorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99738
mdprc 094 05 11 000Newport Medical Instruments IncNewport HT50® Ventilatorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99708
mdprc 093 05 11 000Medela IncTENPAO AC Adaptor, Transformerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99330
mdprc 092 05 11 000Express Diagnostics IncDrugCheckhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99781
mdprc 091 05 11 000CovidienURI-DRAIN Male Urinary Control Device, URI-DRAIN Standard Male External Catheterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99861
mdprc 090 05 11 000Biomet Microfixation6 HOLE REGULAR DOUBLE (Y) PLATEhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98786
mdprc 089 05 11 000Baxter HealthcareLOGIX Order Entry (OE) Software, managementhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99299
mdprc 077 05 11 000bioMerieux IncBacT/ALERT - FA Reagent Bottle.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99580
mdprc 076 05 11 000Stryker MedicalImpression Mattresshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99454
mdprc 075 05 11 000Siemens Medical SolutionsARTISTE , ONCOR and PRIMUS digital accelerators with syngo RT Therapist v4.1 and 4.2 systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99529
mdprc 074 05 11 000Salter LabsAdult Nasal Cannulahttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99597
mdprc 073 05 11 000Beckman Coulter IncSYNCHRON Systems Calibrator http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99589
mdprc 072 05 11 000Varian Medical SystemsHigh Energy Linear Acceleratorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99592
mdprc 071 05 11 000Beckman CoulterCOULTER® Ac"T" 5diff Fix Reagent. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99603
mdprc 070 05 11 000Varian Medical SystemsEclipse Treatment Planning System, Client software versions 8.0 through 8.6http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99625
mdprc 069 05 11 000Siemens Medical SolutionsARTISTE , ONCOR and PRIMUS accelerators.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99531
mdprc 068 05 11 000Philips HealthcarePAS-210 Remote Active Speakers Kit.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99864
mdprc 067 05 11 000Beckman Coulter IncAccess Immunoassay Systems, Thyroglobulinhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=96293
mdprc 066 05 11 000Baxter HealthcareBaxter Colleague, Colleague CX and Colleague CXE Infusion Pumps, Single Channel Volumetric Infusion Pumpshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99634
mdprc 051 05 11 000Siemens Medical SolutionsARTISTE / RT Therapist v4.1 system.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99503
mdprc 049 05 11 000Becton Dickinson & Co. (BD).BD Nokor Admix Needle.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99380
mdprc 048 05 11 000StatSpin, Inc.Statspin Express 4 Centrifuge.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=96248
mdprc 047 05 11 000Digisonics IncManagement system, DigiView softwarehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99270
mdprc 046 05 11 000Animas CorporationCartridge/Syringe Piston component of Insulin Pumphttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98100
mdprc 032 05 11 000Philips Medical SystemsGamma camera, Brightview XCThttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98985
mdprc 030 05 11 000SIEMENSRadiology, Siemens ACUSONhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=84543
mdprc 029 05 11 000SIEMENSACUSON S2000 ABVS Ultrasound Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99480
mdprc 028 05 11 000Biomet 3i IncDental Implants, Osseotite Certain Implant(s)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98994
mdprc 027 05 11 000Becton Dickinson & Co. (BD)IVD, BACTEC MGIT AST systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99444
mdprc 026 05 11 000Baxter HealthcareBaxter Portable Elastomeric Infusion Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98608
mdprc 025 05 11 000Allied Healthcare Products IncCarbon Dioxide Absorbent Granules, CarbO2Limehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=95245
mdprc 016 05 11 000Biomet IncLow Profile Self-Tapping Bone Screwhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98992
mdprc 014 05 11 000Beckman Coulter IncCoulter Cellular Analysis System, UniCel DxH 800http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98899
mdprc 013 05 11 000Carl Zeiss Meditec IncTomographic and biomicroscopic imaging devicehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99272
mdprc 010 05 11 000Varian Medical Systems4D Intergrated Treatment Consolehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98761
mdprc 009 05 11 000SIEMENSACUSON Antares System, ACUSON Sequoia Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=84462
mdprc 008 05 11 000Digisonics IncDOCTORS REVIEW SYSTEMhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99188
mdprc 007 05 11 000Radiometer America IncPortable Blood Gas Analyzer System - ABL90 FLEXhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98848
mdprc 006 05 11 000Neuro Resource Group IncInterX Sport Deviceshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98823
mdprc 005 05 11 000DePuy International LimitedConfidence® Introducer Needle Side Hole, Confidence® Diamond Tip Introducer Needlehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98846
mdprc 004 05 11 000Bio-Rad Laboratories IncBioPlex 2200 EBV IgG Calibrator Sethttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98905
mdprc 003 05 11 000Biomet IncBiomet CC I-Beam Tibial Platehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99023
mdprc 063 04 11 000Advanced Instruments IncMulti-Sample Osmometerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98087
mdprc 062 04 11 000Beckman Coulter IncUnicel® DXC and SYNCHRON® LX Chemistry Analyzershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98092
mdprc 061 04 11 000SIEMENSAcuson X300http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=84981
mdprc 060 04 11 000SIEMENSSiemens ACUSON Ultrasound systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=84555
mdprc 059 04 11 000The Anspach Effort, Inc.Sterile Bone Cutting Burhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97849
mdprc 058 04 11 000Gendex Dental SystemsOrthoralix Panoramic Dental X-Ray Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97680
mdprc 051 04 11 000Terumo Cardiovascular Systems CorporationSarns Flexible Weighted Suckerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98691
mdprc 050 04 11 000Siemens Medical SolutionsLANTIS Oncology Information System with MEDOne Modulehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=80569
mdprc 049 04 11 000Siemens Medical SolutionsLANTIS Oncology Information Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=84912
mdprc 048 04 11 000Medical Positioning IncRapid Response HUT Tablehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98168
mdprc 047 04 11 000Beckman Coulter IncUNICEL DXC SYNCHRON SYSTEMShttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98005
mdprc 046 04 11 000Ellex Medical Pty LtdEllex Solo, Ellex Tango, Ellex Super, Alcon and Ellex Ultra ophthalmic lasershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98270
mdprc 045 04 11 000DePuy International LimitedDePuy Mitek FMS Irrigation Intermediary Tubehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=96020
mdprc 044 04 11 000Dental Equipment LLCDCI Equipment; Marus MaxStar; Marus NuStar; Pelton & Crane Spirithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98425
mdprc 035 04 11 000Bio-Rad Laboratories IncVARIANT II TURBO Hemoglobin, tests Cartridge Setshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=88565
mdprc 034 04 11 000Beckman Coulter IncAccess Free T4 Calibratorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98567
mdprc 029 04 11 000Stryker EndoscopyInflow/Outflow Cannulahttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98484
mdprc 028 04 11 000Siemens Medical SolutionsACUSON S2000 Ultrasound Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=80551
mdprc 027 04 11 000Penner Mfg IncPenner Patient Transfer/Lift Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98916
mdprc 026 04 11 000GE HealthcareGE CARESCAPE Monitorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98873
mdprc 025 04 11 000Bio-Rad Laboratories IncVariant II Turbohttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=89009
mdprc 024 04 11 000Biomet IncCURVTEK eye needle http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98788
mdprc 023 04 11 000Teleflex MedicalRusch Irrigation Tray w/Bulbhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97966
mdprc 022 04 11 000Steris CorpHarmony Monitor Arm Adapterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98365
mdprc 021 04 11 000Linvatec CorpArticulating Arm, Secondary Flat Panelhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97963
mdprc 020 04 11 000Beaver Visitec International LtdBD Beaver XStar Safety Crescent Knifehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98366
mdprc 010 04 11 000Siemens Medical SolutionsTEE Transducer, Ultrasound Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=84089
mdprc 009 04 11 000King Systems Corp.King LT(S)-D Oropharyngeal Airwayhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97483
mdprc 008 04 11 000ConMed Linvatec CorporationMicro Sagittal Bladehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97969
mdprc 007 04 11 000Stanley Healthcare SolutionsStanley Bed-Checkhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97928
mdprc 006 04 11 000ITCHgb Pro Professional Hemoglobin Testing systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97375
mdprc 005 04 11 000HemoCue A BHEMOCUE Analyzershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=96752
mdprc 004 04 11 000Cincinnati Sub-Zero Products IncBlanketrol Hyper/Hypothermia Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97410
mdprc 003 04 11 000Becton Dickinson & Co. (BD)BD Phoenix" Panelhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98199
mdprc 002 04 11 000BD BiosciencesCellQuest Pro SWhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=96797
mdprc 121 03 11 000Bio-Rad Laboratories IncVARIANT Sickle Cell Short Programhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=92217
mdprc 115 03 11 000Stryker InstrumentsInterventional Pain - Percutaneous Discectomy Probehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97708
mdprc 114 03 11 000Siemens Medical SolutionsACUSON Systems, SONOVISTA Systems, SONOLINE Antares Systems, Antares PE Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=94615
mdprc 113 03 11 000Siemens Medical SolutionsAcuson S2000 Ultrasound Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=89306
mdprc 112 03 11 000Siemens Medical SolutionsCoherence Dosimetristhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=89038
mdprc 110 03 11 000SIEMENSACUSON AcuNav ultrasound cathetershttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=84253
mdprc 109 03 11 000Philips Medical SystemsBrilliance 64 ( Computed Tomography X-Ray System)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=96631
mdprc 108 03 11 000OssurOssur Total Kneehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97954
mdprc 107 03 11 000DePuy International Limited(Attached)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=96113
mdprc 106 03 11 000Beckman Coulter IncAccess Thyroglobulin Antibody IIhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97800
mdprc 103 03 11 000Philips Medical SystemsAllura FD10, FD20, CV20 systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=95402
mdprc 102 03 11 000DiaSorin IncETI-AB-AUK PLUS kitshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97783
mdprc 101 03 11 000Depuy Orthopaedics, IncAFFIXUS Lag Screw Drillhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97749
mdprc 100 03 11 000ThermoFisher ScientificThermo Scientific Microm HM 550 Cold Disinfection Cryostat, Thermo Scientific HM 560 Cold Disinfection Cryostat,http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97577
mdprc 099 03 11 000DiaDexus, IncPLAC Test ELISA Kithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=94160
mdprc 080 03 11 000Stryker EndoscopyStryker Stiletto Electrosurgical Probe (E-Probe)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=91342
mdprc 078 03 11 000Medtronic Xomed IncThermasplint Kit, Nasal Splint Kithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98265
mdprc 077 03 11 000King Systems Corp.King Systems LT-D and LTS-D Oropharyngeal Airwayhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97875
mdprc 076 03 11 000Hill Rom IncSabina Sit-in-Stand liftshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97285
mdprc 075 03 11 000GE HealthcareGE senographe systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97346
mdprc 074 03 11 000Cytyc Prenatal Products/Hologic IncRapid fFN (collection kit) http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=87585
mdprc 073 03 11 000Bio-Rad Laboratories IncPhD System EIA/IFA Softwarehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97382
mdprc 072 03 11 000Abbott Laboratories IncCELL-DYN Emerald Hematology Analyzer Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=90074
mdprc 071 03 11 000Abbott Laboratories IncAbbott brand CELL-DYN Emerald Diluent Reagenthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=95077
mdprc 070 03 11 000Abbott Laboratories IncThe Waste Line Assembly and the Waste Outlet Tubing and the Waste Bottle Cablehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=88956
mdprc 069 03 11 000Abbott Laboratories IncAbbott CELL-DYNhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=81733
mdprc 053 03 11 000TomoTherapy IncorporatedTomoTherapy Hi-ART radiotherapy Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97745
mdprc 052 03 11 000Roche Diagnostics CorpFactor V Leiden kit, Factor II (prothrombin) kit, MagNA Pure LC 2.0 Instrumenthttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=96480
mdprc 051 03 11 000Bio-Rad Laboratories IncAutoimmune EIA Anti-dsDNA Test Kithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=92481
mdprc 050 03 11 000Medtronic Spine LLC CoMedtronic Bone Cementhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=88623
mdprc 049 03 11 000Gen Probe IncorporatedAccuProbehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=90838
mdprc 048 03 11 000Abbott Point of Carei-STAT G3+ Cartridgehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=94168
mdprc 047 03 11 000Abbott Laboratories IncCELL-DYN 4000 Vent Head Spring Assemblyhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=88541
mdprc 034 03 11 000Terumo Cardiovascular Systems CorporationTerumo Advanced Perfusion System 1FDA
mdprc 033 03 11 000Siemens Medical SolutionsMOSAIQ Oncology Information SystemFDA
mdprc 032 03 11 000Luxottica Optical ManufacturingPolycarbonate prescription single vision lensesFDA
mdprc 031 03 11 000Hill Rom IncTotalCare beds P1900 with P500 Microclimate Management Surface Hill Rom, VersaCare beds P3200 and P3201 with P500 Microclimate Management Surface Hill Rom, VersaCare P500 Microclimate Management Surface Upgrade Kits P3218A and P3219A Hill-rom.FDA
mdprc 030 03 11 000Biomet IncARCOS Modular Revision System Torque Limiting T-Handle 55 inch- pounds, REF 31-301850FDA
mdprc 026 03 11 000Ethicon IncDermabond Topical Skin Adhesive, 2-Octo Cyanoacrylate, Sterile, Rx onlyFDA
mdprc 025 03 11 000Siemens Medical SolutionsARTISTE System Digital Linear AcceleratorFDA
mdprc 024 03 11 000Bio-Rad Laboratories IncBio-Rad PhD SystemFDA
mdprc 023 03 11 000Philips HealthcareBuckyDiagnost with Optimus GeneratorFDA
mdprc 022 03 11 000Bio-Rad Laboratories IncQuantase Neonatal Accessory KitsFDA
mdprc 021 03 11 000Medtronic Navigation IncSurgical Navigation SystemFDA
mdprc 020 03 11 000Elekta IncDesktop ProFDA
mdprc 019 03 11 000Gendex Dental SystemsWall Mounting PlateFDA
mdprc 018 03 11 000Elekta IncPrecisePLAN Treatment Planning SystemFDA
mdprc 017 03 11 000Fresenius Medical CareHemodialysis MachineFDA
mdprc 016 03 11 000Elekta IncPrecisePLAN Treatment Planning SystemFDA
mdprc 015 03 11 000Biomet IncCylindrical Bullet Nose ReamerFDA
mdprc 014 03 11 000Aesculap IncAesculap MicroSpeed Uni Control BoxFDA
mdprc 012 03 11 000Roche Diagnostics CorpCOBAS AmpliPrep/COBAS TaqManFDA
mdprc 011 03 11 000Quidel CorporationQuickVue One-Step hCG Urine testFDA
mdprc 066 02 11 000Cook Inc Central Venous Catheter Tray FDA
mdprc 065 02 11 000Siemens Medical Solutions ARTISTE MV with Artiste Digital Linear Accelerators FDA
mdprc 064 02 11 000Integra LifeSciences Corporation Integra Radionics HRAIM Intubation Head Ring Assembly FDA
mdprc 063 02 11 000Hill Rom Inc Comfort Sling Plus FDA
mdprc 062 02 11 000AGFA Corp. Cardiovascular Review Station FDA
mdprc 060 02 11 000SIEMENSACUSON S2000 ultrasound system , V5M TEE Transducer FDA
mdprc 059 02 11 000Generic Medical Devices GMD UNIVERSAL URINARY INCONTINENCE SLING FDA
mdprc 058 02 11 000DePuy International LimitedS-ROM distal femoral cutting block guide FDA
mdprc 047 02 11 000Arrow International Inc JUGULAR PUNCTURE KIT, Catheterization kit , Anesthesia kit and Arterial line kit , FDA
mdprc 046 02 11 000Heart Sync, IncMedstorm Adult Radiolucent ElectrodeFDA
mdprc 045 02 11 000Gendex Dental SystemsPanoramic Dental X-Ray SystemFDA
mdprc 044 02 11 000Aspen Surgical Products, Inc.Corneal Marking PadFDA
mdprc 043 02 11 000Abbott Point of CareCelite ACT CartridgeFDA
mdprc 040 02 11 000Ortho Organizers IncClassOne Orthodontics Buccal SS TubesFDA
mdprc 039 02 11 000GE HealthcareGE Centricity LaboratoryFDA
mdprc 038 02 11 000Bio-Rad Laboratories IncBio-Rad Variant II Turbo Link Hemoglobin Testing SystemFDA
mdprc 037 02 11 000AbbottBlood Glucose Monitoring Test StripsFDA
mdprc 036 02 11 000Terumo Cardiovascular Systems CorporationVIRTUOSAPH (TM) ENDOSCOPIC VEIN HARVESTING DISPOSABLE SYSTEMFDA
mdprc 035 02 11 000Elekta IncLeksell GammaPlan ( radiation therapy) FDA
mdprc 034 02 11 000AMS Innovative Center - San JoseAMS GreenLight PV Surgical Laser SystemFDA
mdprc 023 02 11 000MAQUET Cardiovascular LLCHEARTSTRING Aortic Cutter 4.3 mmhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=94678
mdprc 022 02 11 000International Technidyne CorporationHemochron Whole Blood Coagulation Systemshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=96055
mdprc 021 02 11 000Hill Rom IncTotalCare Bedhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97267
mdprc 020 02 11 000Abaxis IncPiccolo Comprehensive Metabolic Reagent Dischttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=95843
mdprc 019 02 11 000Siemens Medical SolutionsLinear Medical Accelerator ARTISTE MV systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=84556
mdprc 016 02 11 000Stryker Howmedica Osteonics CorpOrthopaedics device, Omnifithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=93724
mdprc 015 02 11 000Radiometer America IncBlood Analyzer , ABL90 FLEXhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=95727
mdprc 014 02 11 000Medtronic Navigation IncVertex Max Drill Tubehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=96537
mdprc 013 02 11 000IMPAC Medical Systems IncSEQUENCER for Mosaiq .http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=90908
mdprc 012 02 11 000Vital Signs Inc A GE Healthcare CoGreenLight II Laryngoscope Handleshttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=96283
mdprc 011 02 11 000Peak SurgicalTissue Dissection Device, PEAK brand PlasmaBlade EXThttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=84458
mdprc 010 02 11 000Arstasis Inc.Access Kit, Arstasls One Access Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=96420
mdprc 007 02 11 000Varian Medical SystemsVarian brand C-Series Clinacs and Acuity, Exact Couch Tophttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=93281
mdprc 006 02 11 000Solta Medical, Inc.Fraxel restore® Dual Laser Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=96741
mdprc 005 02 11 000Siemens Medical SolutionsAcuson Antares PE , Acuson with Physio Module , ACUSON S2000http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=86504
mdprc 004 02 11 000Accuray IncCyberKnife Treatment Planning Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=88658
mdprc 082 01 11 000King Systems Corp.KING LT -D Laryngeal Tube, Oropharyngeal Airwayhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=88259
mdprc 081 01 11 000Boston Scientific CorporationRF Ablation System Foot Switch, used with the EPT-1000 RF Generatorhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=84916
mdprc 050 01 11 000Stryker Instruments.SmartPump Tourniquet Pumphttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=94405
mdprc 049 01 11 000Mizuho OSIOperating Room Table, Mizuho ProFx 6850http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=94677
mdprc 048 01 11 000Cook Endoscopy.Cholangioscopy Access Balloonhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=96679
mdprc 047 01 11 000Abbott Point of Care.i-STAT G3+, CG8+Cartridgehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=93504
mdprc 032 01 11 000Siemens Medical Solutions.Acuson Antares Ultrasound Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=89055
mdprc 031 01 11 000Carl Zeiss Meditec Inc.Surgical microscope, VISU 200http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=83806
mdprc 029 01 11 000Philips Nuclear Medicine.Precedence SPECT/CT System Upper Patient Pallet.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=79567
mdprc 028 01 11 000Concentric Medical Inc.Concentric 7F Balloon Guide Catheterhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=80199
mdprc 027 01 11 000Bunnell Inc.Life Pulse High-Frequency Ventilators.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=96004
mdprc 026 01 11 000Accuray Inc.RoboCouch Patient Support System, a subsystem of the Cyberknife Robotic Radiosurgery Systemhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=84538
mdprc 020 01 11 000Vance Products Incorporated.Universa Soft Ureteral Stent and positionerhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=95928
mdprc 019 01 11 000Stryker Endoscopy.Stryker Digital Capture Pro 2http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=88894
mdprc 014 01 11 000Boston Scientific Corporation.Guide Catheter.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=89014
mdprc 013 01 11 000Terumo Cardiovascular Systems Corporation.Terumo Advanced Perfusion System 1.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=96152
mdprc 009 01 11 000AngioScore Inc.Angioplasty Scoring Balloon Catheters, AngioSculpt Percutaneous Transluminal http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=95719
mdprc 002 01 11 000Galil Medical Inc.Urethral Warmer System.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=95676
mdprc 001 01 11 000AMS Innovative Center - San Jose.Laser System, GreenLight MoXy Fiber Optic.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=94467