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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
Competent Authorities Composite Listing
NCMDR
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 055 12 18 000Elekta Inc.MOSAIQ Radiation Oncology NCMDR
mdprc 036 12 18 000Ethicon Inc.PROXIMATE Hemorrhoidal Circular StaplerNCMDR
mdprc 035 12 18 000Siemens Healthcare Diagnostics GmbHAtellica IM Anti-Thyroglobulin (aTG) Positive BiasNCMDR
mdprc 034 12 18 000Siemens Healthcare Diagnostics GmbHADVIA Centaur Anti-Thyroglobulin (aTG) Positive Bias, ADVIA Centaur, XP, XPT and CPNCMDR
mdprc 033 12 18 000AbbottCP3000 w/ CTS and w/o CTS 230VNCMDR
mdprc 023 12 18 000Roche Diagnostics COBAS INTEGRA® 400 plus and cobas c 111 analyzerNCMDR
mdprc 042 03 18 001HUMAN Gesellschaft für Biochemica und Diagnostica GmbHIMTEC-ß2-Glycoprotein I-Antibodies IgGNCMDR
mdprc 011 12 18 000Arjo RotoProne Therapy System NCMDR
mdprc 010 12 18 000Boston Scientific Cardiac Resynchronization Therapy (CRT) pacemakers (CRT-Ps) and defibrillators (CRT-Ds) NCMDR
mdprc 009 12 18 000Roche Diagnostics cobas c 311/501/502/701/702NCMDR
mdprc 100 11 18 000AGFA Corp.DX-D 600 X-ray system NCMDR
mdprc 099 11 18 000GE Healthcare Multiple GE MRI systems NCMDR
mdprc 090 11 18 000Maquet Cardiopulmonary Heater-Cooler Unit HCU 40 NCMDR
mdprc 074 11 18 000AbbottMultiple Alinity i ReagentsNCMDR
mdprc 029 09 18 001Siemens Healthcare Diagnostics GmbHLot-to-Lot Variability When Using Dimension® Lipase (LIPL)https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167891
mdprc 056 11 18 000Diagnostica StagoSTACLOT LA (REF. 00600).NCMDR
mdprc 054 11 18 000GE HealthcareCARESCAPE B850 MBC303 monitorsNCMDR
mdprc 053 11 18 000GE HealthcareMedical image management systemNCMDR
mdprc 052 11 18 000Philips HealthcareEfficia 3/5 ECG Trunk Cable, AAMI/IECNCMDR
mdprc 071 04 18 001Draeger Medical Systems IncJaundice Meter JM-103 and JM-105 Out of Range IndicationNCMDR
mdprc 103 07 18 001Ortho-Clinical DiagnosticsVITROS MicroWell AssaysSwissmedic
mdprc 035 11 18 000Abbott Diagnostic International LtdG-Series, E-Series and BCM SCC RAM Inspection and InstallationNCMDR
mdprc 034 11 18 000Siemens Medical SolutionsImage orientation labels with scenario.NCMDR
mdprc 033 11 18 000Philips HealthcarePhilips HeartStart MRx M3538ANCMDR
mdprc 016 11 18 000Boston Scientific SQ-RX Pulse GeneratorNCMDR
mdprc 078 10 18 001BD BD MAX SystemNCMDR , FDA
mdprc 024 08 18 001SIEMENSYsio and Ysio MAX systems and Multix Fusion Analog , Multix Fusion Digital Portable , Multix Fusion Digital Integrated and Multix Fusion Digital WirelessNCMDR
mdprc 056 10 18 001AbbottARCHITECT Free T3 Reagent Kit, ARCHITECT Total T3 Reagent Kit v NCMDR , Swissmedic
mdprc 058 10 18 001AbbottAlinity hq Analyzer and Alinity hs Slide Maker Stainer Module NCMDR
mdprc 004 11 18 000Atrium Medical CorporationATRIUM PVC Thoracic CatheterNCMDR
mdprc 003 11 18 000Siemens Healthcare Diagnostics Dimension Vista System utilising Lactate Dehydrogenase (LDI) Flex reagent cartridge.NCMDR
mdprc 038 10 18 001St. Jude Medical Inc.8-Channel Lead for the St. Jude Medical Infinity™ DBS (Deep Brain Stimulation) SystemNCMDR
mdprc 151 10 18 000Siemens Healthcare Diagnostics Atellica Sample Handler Prime (SH Prime)NCMDR
mdprc 150 10 18 000SIEMENSDimension Vista Intelligent Lab Systems NCMDR
mdprc 149 10 18 000Intuitive Surgical Inc.EndoWrist Monopolar Curved Scissors NCMDR
mdprc 148 10 18 000SIEMENSARTIS zee SystemsNCMDR
mdprc 147 10 18 000Terumo Cardiovascular Systems VirtuoSaph Plus Endoscopic Vessel Harvesting SystemVirtuoSaph Plus Endoscopic Vessel Harvesting SystemNCMDR
mdprc 139 10 18 000AbbottAlinity i Free T3 Reagent Kit NCMDR
mdprc 138 10 18 000Draeger Medical IncMedical Air EnsureBfArM
mdprc 137 10 18 000Lifetech Scientific (Shenzhen) Co., Ltd.Cera Vascular Plug SystemsBfArM
mdprc 136 10 18 000Medtronic SAMon-a-Therm Foley catheters with temperature sensors,,BfArM
mdprc 135 10 18 000Medtronic SAParietex Composite Parastomal MeshBfArM
mdprc 134 10 18 000Smith & Nephew incGII Distal Cutting BlocksBfArM
mdprc 133 10 18 000Zimmer, INCRapidFlap System SpinDown ClampsBfArM
mdprc 003 10 18 001AbbottARCHITECT HAVAb‐IgG Reagent Kit, ARCHITECT HAVAb‐IgM Reagent Kit, Alinity i HAVAb IgG Reagent KitNCMDR
mdprc 119 10 18 000Biosense Webster Inc.THERMOCOOL SMARTTOUCH SF Uni-Directional Navigation Catheter & THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation CatheterNCMDR
mdprc 047 03 17 001Medtronic StrataMR™ Adjustable Valves & Shunts NCMDR, TGA
mdprc 156 07 18 001Siemens Healthcare Diagnostics GmbHADVIA Centaur CKMB Calibrator Bias and Out of Range Results Using Master Curve Material (MCM)NCMDR, FDA
mdprc 108 10 18 000Medtronic SAStealthStation S7 and i7 Systems with Synergy Cranial StealthStation Cranial SoftwareNCMDR
mdprc 107 10 18 000Philips HealthcareBrilliance 6, Brilliance 10. Brilliance 16 & 16 Power, Brilliance 40, Brilliance 64NCMDR
mdprc 106 10 18 000Philips Medical SystemsCombiDiagnost,NCMDR
mdprc 105 10 18 000VOLCANO CORPORATIONIVUS CatheterNCMDR
mdprc 092 10 18 000Ortho-Clinical DiagnosticsVITROS Chemistry Products dLDL Reagent NCMDR
mdprc 091 10 18 000Randox Laboratories Ltd.Evidence Analyser Operator ManualNCMDR
mdprc 090 10 18 000Randox Laboratories Ltd.RX Monaco NCMDR
mdprc 089 10 18 000Medtronic CareLink 2090 and CareLink Encore 29901/29901A ProgrammersNCMDR
mdprc 039 10 18 000Atrium Medical CorporationATRIUM OCEAN, OASIS, EXPRESS and EXPRESS MINI CHEST DRAINSNCMDR
mdprc 029 10 18 000Clearstream Technologies LtdLifeStream Balloon Expandable Vascular Covered StentNCMDR
mdprc 015 10 18 000Accuray Inc.CyberKnife M6 System NCMDR
mdprc 014 10 18 000Datex - Ohmeda IncAisys and Aisys CS2 Anesthesia Devices NCMDR
mdprc 013 10 18 000Siemens Healthcare Diagnostics Atellica® IM 1300 Analyzer, Atellica® IM 1600 Analyzer, Atellica® CH 930 Analyzer, and Atellica® Sample Handler Prime .NCMDR
mdprc 004 10 18 000Medtronic SAMedtronic MiniMed 640G Insulin PumpNCMDR
mdprc 002 10 18 000Becton, Dickinson And CompanyALARIS PCEA ASV Yellow Microbore, ALARIS PCEA ASV Yellow Microbore, ALARIS PCEA Kit ASV Yellow MicroboreNCMDR
mdprc 001 10 18 000Philips HealthcareDigitalDiagnost 4.1.9 / 4.2.6NCMDR
mdprc 063 06 18 001Randox Laboratories Ltd.Troponin T, Liquid Cardiac ControlNCMDR
mdprc 124 09 18 000GE HealthcareGiraffe OmniBed Carestation, Giraffe Incubator Carestation, Giraffe Warmer, Panda iRes Warmer, Panda Freestanding Warmer and Panda Wall MountNCMDR
mdprc 123 09 18 000GE HealthcareGiraffe OmniBed NCMDR
mdprc 112 09 18 000B Braun Medical Inc.220-240V Unit Cable (power cord) for Infusomat fmS, Infusomat P and SpaceCoverNCMDR
mdprc 009 09 18 001Roche Diagnostics CorpCoaguChek (XS PT, XS PT PST, and PT) stripsNCMDR
mdprc 094 09 18 000Boston Scientific Cardiac Rhythm Management GroupCardiac Resynchronization Therapy pacemakers (VISIONIST™, ™,) and pacemakers (ACCOLADE™, PROPONENT™ and ESSENTIO™)NCMDR
mdprc 093 09 18 000Cooper Surgical, Inc.LONE STAR® SINGLE-USE ELASTIC STAYSNCMDR
mdprc 092 09 18 000Saudi Mais for Medical ProductsSterile single use Laryngeal Mask AirwayNCMDR
mdprc 083 09 18 000AbbottAlinity i Processing ModuleNCMDR
mdprc 082 09 18 000C R Bard Inc.HICKMAN Central Venous Catheter NCMDR
mdprc 065 09 18 000Abbotti-STAT 1 Wireless Analyzers and i-STAT Alinity InstrumentsNCMDR
mdprc 064 09 18 000Stryker OrthopaedicsSTERILE FLUTED HEADLESS 1/8" PIN 3.5" LONGNCMDR
mdprc 030 09 18 000Philips EverFlo (Oxygen Concentrator)NCMDR
mdprc 028 09 18 000AbbottAccelerator a3600NCMDR
mdprc 027 09 18 000AbbottAccelerator APSNCMDR
mdprc 026 09 18 000GE HealthcareDash 3000/4000/5000, Solar 8000M/i, and Solar 9500 patient monitorsNCMDR
mdprc 025 09 18 000Roche Diagnostics CorpCybersecurity updates in Accu-Chek Inform II system,
NCMDR
mdprc 024 09 18 000STERIS CorporationORT 353D, ORT 353C and ORT 01G Orthopaedic ExtensionsNCMDR
mdprc 022 09 18 000Abbott Cardiovascular and NeuromodulationCentriMag Acute Circulatory Support System MotorNCMDR
mdprc 021 09 18 000AbbottAlinity hq AnalyzerNCMDR
mdprc 020 09 18 000AbbottAlinity s SystemNCMDR
mdprc 019 09 18 000Arjo Huntleigh - electric bedsCitadel Plus (Fortress) Power Drive software version V1.17NCMDR
mdprc 018 09 18 000GE HealthcareB20/B20i/B40/B40i (Bx0), and B105/B125 (B1x5) patient monitorsNCMDR
mdprc 017 09 18 000GE HealthcareCARESCAPE B450, B650, and B850 (Bx50) monitorsNCMDR
mdprc 016 09 18 000Getinge Disinfection ABARCUS treatment tablesNCMDR
mdprc 015 09 18 000Philips BurtonPhilips Efficia DFM100 Defibrillator/ MonitorNCMDR
mdprc 010 09 18 000Roche Diagnostics CorpCobas e 411 analyzerNCMDR
mdprc 098 08 18 000Intuitive Surgical Incda Vinci S/Si 8 mmNCMDR
mdprc 097 08 18 000Leica Microsystems Inc.Leica M525 F20NCMDR
mdprc 094 08 18 000Ortho-Clinical DiagnosticsVITROS 5600 Integrated System NCMDR
mdprc 093 08 18 000Varian Medical SystemsTrueBeam, TrueBeam STx, VitalBeam and EDGE treatment delivery systemsNCMDR
mdprc 092 08 18 000Maquet Cardiopulmonary BE-HLS 7050# HLS Set Advanced 7.0https://ncmdr.sfda.gov.sa/secure/devicerecall.aspx?cid=FD1CECD31D
mdprc 091 08 18 000Medtronic MiniMed remote controller (MMT-500 or MMT-503)NCMDR
mdprc 072 08 18 000Roche Diagnostics GmbHFLO LOK III DispenserNCMDR
mdprc 055 08 18 000Philips HealthcarePhilips Allura Xper, UNIQ and CentronNCMDR
mdprc 054 08 18 000AbbottAlinity ci‐series System Control Module (SCM).NCMDR
mdprc 026 08 18 000AGFA Corp.Enterprise Imaging for Radiology.NCMDR
mdprc 025 08 18 000EOS ImagingsterEOS image review workstationNCMDR
mdprc 019 08 18 000Ortho-Clinical DiagnosticsVITROS Chemistry Products Cl- Slides & VITROS Chemistry Products CREA SlidesNCMDR
mdprc 010 08 18 000Ethicon Inc.ETHICON Generator Gen11NCMDR
mdprc 009 08 18 000Maquet Cardiopulmonary AGHCU 40NCMDR
mdprc 155 07 18 000Immucor GmbH.antigen typing for vial 4NCMDR
mdprc 154 07 18 000Terumo Cardiovascular Systems CorporationCDI Blood Parameter Monitoring System 500 H/Sat Probe AssemblyNCMDR
mdprc 134 07 18 000AbbottARCHITECT EBV VCA IgM Reagent KitNCMDR
mdprc 133 07 18 000GE Healthcarearestation 620/650/650c A1, Carestation 620/650/650c A2, Carestation 30 and 9100c NXT Anesthesia SystemsNCMDR
mdprc 068 06 18 001C R Bard IncARCTIC SUN 5000 Temperature Management Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165300
mdprc 126 07 18 000Mast Group Ltd.Ciprofloxacin 0.5mg/L PlateNCMDR
mdprc 125 07 18 000AbbottARCHITECT Creatine KinaseNCMDR
mdprc 124 07 18 000AbbottARCHITECT c4000, c8000 and c16000 Processing ModuleNCMDR
mdprc 123 07 18 000AbbottAlinity c Creatine KinaseNCMDR
mdprc 122 07 18 000Ortho-Clinical DiagnosticsVITROS Chemistry Products Na+ SlidesNCMDR
mdprc 121 07 18 000Philips HealthcareAllura Xper, integris systems.NCMDR
mdprc 092 07 18 000bioMerieux IncVIDAS CA 15-3NCMDR
mdprc 091 07 18 000DiaMed GmbH.Anti-JkNCMDR
mdprc 077 07 18 000AbbottAlinity ci‐series System Control Module (SCM) NCMDR
mdprc 068 07 18 000Siemens Healthcare Diagnostics Dimension Vista LOCI Reaction VesselsNCMDR
mdprc 056 07 18 000Abbott Laboratories IncAlinity s SystemNCMDR
mdprc 055 07 18 000B. BRAUN MEDICAL INCPerifix Catheter ConnectorNCMDR
mdprc 039 07 18 000Philips HealthcareBrilliance 64, Brilliance CT BigBore, Brilliance iCT,NCMDR
mdprc 038 07 18 000Philips HealthcareSureSigns VS & VM Monitors, and View Station (VSV)NCMDR
mdprc 028 07 18 000BioMerieux Inc.BACT/ALERT® VIRTUO® Microbial Detection SystemNCMDR
mdprc 027 07 18 000AGFA Corp. Enterprise Imaging for Radiology NCMDR
mdprc 002 07 18 000BeekleyS-SPOT, Tomo-SPOT, O-SPOTNCMDR
mdprc 001 07 18 000Roche Diagnostics cobas p 612 pre-analytical system (LCP1) NCMDR
mdprc 118 06 18 000AbbottAlinity hq Analyzer NCMDR
mdprc 117 06 18 000GE HealthcareCARESCAPE R860, ENGSTROM CARESTATION and ENGSTROM PRONCMDR
mdprc 097 05 18 001Draeger Medical Systems Inc.Fabius, Apollo & Perseus devices NCMDR, FDA
mdprc 103 06 18 000AbbottAlinity s System NCMDR
mdprc 102 06 18 000Arrow International Inc. Arrow® HANDS-OFF® Thermodilution CatheterNCMDR
mdprc 101 06 18 000Boston Scientific Maestro 4000 Cardiac Ablation SystemNCMDR
mdprc 100 06 18 000GE HealthcareCARESCAPE Monitor B650 NCMDR
mdprc 099 06 18 000LivaNova Perceval Sutureless Heart ValveNCMDR
mdprc 098 06 18 000Medtronic EnTrust and Escudo VR/DR/AT ICDsNCMDR
mdprc 097 06 18 000Medtronic Percepta™ CRT-P MRI SureScan™ and Percepta™ Quad CRT-P MRI SureScan™ PacemakersNCMDR
mdprc 096 06 18 000Ortho-Clinical DiagnosticsVITROS Chemistry Products Na+ Slides NCMDR
mdprc 095 06 18 000SIEMENSArtis Q/Pheno systems NCMDR
mdprc 094 06 18 000Stryker NeurovascularSYNCHRO NCMDR
mdprc 067 06 18 000GE HealthcareTwinSpeed, Signa Infinity, Excite, Signa Infinity with Excite Technology, Signa Excite 3T, Signa Excite HD 1.5T, Signa Excite HD 3.0T, 1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant.NCMDR
mdprc 066 06 18 000GE HealthcareDiscovery MR750wNCMDR
mdprc 065 06 18 000Medtronic SASingle Chamber Temporary External Pacemaker 53401NCMDR
mdprc 064 06 18 000Philips HealthcareAllura Xper, UNIQ and CentronNCMDR
mdprc 051 10 17 001Becton Dickinson & Co. (BD)Phaseal Secondary Set (C61)NCMDR
mdprc 036 06 18 000PENTAX Europe GmbHPENTAX Duodenoscope ED34-i10TNCMDR
mdprc 030 05 18 001HeartWare Inc.Medtronic HeartWare™ HVAD™ SystemNCMDR
mdprc 022 06 18 000Siemens Healthcare Diagnostics GmbHDimension Integrated Chemistry Systems…NCMDR
mdprc 021 06 18 000Leica Microsystems Inc.M320 Microscope SystemNCMDR
mdprc 140 05 18 000DePuy International LimitedCORAIL AMT Neck Trials Surgical InstrumentsNCMDR
mdprc 133 05 18 000Becton, Dickinson And CompanyBD SmartSite Administration SetsNCMDR
mdprc 024 05 18 001Medtronic Covidien Endo GIA™ Articulating Loading UnitsNCMDR
mdprc 125 05 18 000SIEMENSAXIOM Artis and Artis Zee SystemsNCMDR
mdprc 120 05 18 000Joerns Healthcare LimitedP.R.O. Matt and ProCair MattressesNCMDR
mdprc 119 05 18 000Randox Laboratories Ltd.Liquid Assayed Specific Protein ControlsNCMDR
mdprc 098 05 18 000Bio RadLiquichek Urine Chemistry Control, Level 2NCMDR
mdprc 096 05 18 000St. Jude Medical Inc.Confirm RX NCMDR
mdprc 095 05 18 000Zimmer Inc.Echo Instrument Case Shell - Outer Case Vault Only and Comprehensive Reverse Shoulder Instrument - Outer Case Vault OnlyNCMDR
mdprc 072 05 18 000Ortho-Clinical DiagnosticsVITROS Chemistry Products PHYT Slides NCMDR
mdprc 071 05 18 000Philips HealthcareXper Flex Cardio Patient Monitoring SystemNCMDR
mdprc 058 05 18 000Siemens Healthcare Diagnostics ADVIA Centaur®, ADVIA Centaur®XP, ADVIA Centaur®XPT, and ADVIA Centaur®CP NCMDR
mdprc 057 05 18 000Smith & Nephew inc. GII Tibial Punch NCMDR
mdprc 031 05 18 000Physio-Control Inc. LIFEPAK® 15 and LIFEPAK® 12 with End-Tidal CO2 optionNCMDR
mdprc 026 05 18 000Philips HealthcareIntelliVue MX40 NCMDR
mdprc 025 05 18 000Philips HealthcareOmniDiagnost-Eleva and OmniDiagnost-Classic NCMDR
mdprc 023 05 18 000Siemens Healthcare Diagnostics Dimension clinical chemistry system and Dimension Vista System, Alkaline Phosphatase Calibrator (ALPI CAL)NCMDR
mdprc 022 05 18 000Terumo BCT Inc.Spectra Optia Apheresis SystemsNCMDR
mdprc 010 05 18 000bioMerieux IncVITEK MSNCMDR
mdprc 159 04 18 000GE HealthcareRevolution EVO & Optima CT660, CT670, CT680, CT540 Internal Electrical Cable NCMDR
mdprc 144 04 18 000B Braun Medical Inc.Askina Calgitrol Paste, Askina GelNCMDR
mdprc 129 04 18 000Siemens Healthcare Diagnostics Dimension clinical chemistry system and Dimension Vista System Gentamicin (GENT) Flex reagent cartridgeNCMDR
mdprc 064 03 18 001MAQUETServo-air, Servo-I, Servo-s, Servo-n and Servo-uNCMDR
mdprc 127 04 18 000Saudi Mais for Medical ProductsSterile Single Use Spinal needle with IntroducerNCMDR
mdprc 099 04 18 000MedtronicCovidien EEA Hemorrhoid and Prolapse Stapler Sets with DST Series TechnologyNCMDR
mdprc 097 04 18 000ArjoHuntleighEntroy Pool LiftersNCMDR
mdprc 096 04 18 000St. Jude Medical IncBattery Performance Alert and Cybersecurity Firmware Updates for Certain ICD & CRT-D DevicesNCMDR
mdprc 095 04 18 000Alrazi Pharma IndustriesLiquid Acid Concentrate for Haemodialysis-HDA08NCMDR
mdprc 094 04 18 000AesculapSurgical PENIS CLAMPNCMDR
mdprc 093 04 18 000AbbottAlinity i HBsAg CalibratorsNCMDR
mdprc 070 04 18 000Roche Diagnostics Corpcobas MPX test, CE-IVD NCMDR
mdprc 062 04 18 000Siemens Healthcare Diagnostics GmbHADVIA Chemistry Systems Urea Nitrogen (UN)NCMDR
mdprc 047 04 18 000bioMerieux IncVIDAS 3NCMDR
mdprc 036 04 18 000GE HealthcareDiscovery IGS 730/740, Innova IGS 620/630/520/530/540 systemsNCMDR
mdprc 035 04 18 000Roche Diagnosticscobas® 8000 modular analyzer series & cobas e 801 moduleNCMDR
mdprc 034 04 18 000Shanghai Kinmed Import & Export Co., LtdKinmed Aerosol MaskNCMDR
mdprc 033 04 18 000DePuySynthesRetractor f/Sciatic Nerve & Retractor f/Sciatic Nerve longNCMDR
mdprc 028 04 18 000Terumo Cardiovascular Systems CorporationSarns TCM and TCM II Cooling and Heating SystemsNCMDR
mdprc 157 03 18 000Philips HealthcareBU IGT Systems, MultiDiagnost-ElevaNCMDR
mdprc 156 03 18 000Arcomed AGSyramed μSP6000 and Volumed μVP7000 NCMDR
mdprc 155 03 18 000Sekisui DiagnosticsCP3000 SystemNCMDR
mdprc 124 03 18 000GE HealthcareLOGIQ 9, LOGIQ E9, Vivid 7, Vivid E7, Vivid E9, Vivid E80, Vivid E90, and Vivid E95NCMDR
mdprc 113 03 18 000GE HealthcareDPX-NT, DPX Bravo, DPX Duo, DPX-MD, Prodigy, Prodigy Advance SystemsNCMDR
mdprc 112 03 18 000MAQUET Inc.VOLISTA StandOP and TRIOPNCMDR
mdprc 102 03 18 000Draeger Medical Systems The Infinity® Acute Care System and Standalone Infinity M540 patient monitor.NCMDR
mdprc 101 03 18 000Philips HealthcareCertain MRI systems with a metal burst diskNCMDR
mdprc 075 03 18 000Philips HealthcareAllura Xper and UNIQ Systems with FlexVision Large Screen MonitorNCMDR
mdprc 041 03 18 000Baxter Ultrafilter U9000 NCMDR
mdprc 040 03 18 000Hill Rom Inc. Progressa Bed Systems NCMDR
mdprc 086 11 17 001Cordis CorporationCordis S.M.A.R.T.® Flex Vascular Stent System.NCMDR
mdprc 021 03 18 000Randox Laboratories Ltd.Lipase assay on RX instrumentsNCMDR
mdprc 139 02 18 000GE HealthcareCentricity PACS-IWNCMDR
mdprc 138 02 18 000AbbottAlinity hq Analyzer NCMDR
mdprc 137 02 18 000Philips HealthcareIngenuity Flex, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Brilliance iCT, Brilliance iCT SP, Brilliance Big Bore Oncology, Brilliance Big Bore Radiology, Brilliance 16, Brilliance 40, Brilliance 64, IQon, Brilliance 6, Brilliance 10NCMDR
mdprc 124 02 18 000Draeger Medical Systems Inc.Fabius GS Premium, Tiro, Tiro D-M, MRI, plus, plus XL NCMDR
mdprc 123 02 18 000Philips HealthcareHeartStart FRx, HeartStart Home, and Heartstart OnSite AEDs NCMDR
mdprc 099 02 18 000Immucor GmbH.Panocell®-10, Ficin SolutionNCMDR
mdprc 098 02 18 000FUJIFILM CorporationDuodenoscope Model ED-530XTNCMDR
mdprc 097 02 18 000Roche Diagnostics Hematoxylin II and Horseradish Peroxidase reagents NCMDR
mdprc 071 02 18 000Fresenius Kabi LtdAgilia Volumat Infusion Set portfolioNCMDR
mdprc 070 02 18 000Boston ScientificCapio™ Suture Capturing Devices (SLIM, Standard, Open Access, RP), Uphold LITE with Capio™ SLIM Vaginal Support System, NCMDR
mdprc 069 02 18 000AbbottAlinity ci‐series System Control Module (SCM)NCMDR
mdprc 046 02 18 000GE HealthcareGE TEE probes used with Tristel Trio Wipes SystemNCMDR
mdprc 045 02 18 000Medtronic Bio-Cal Temperature ControllerNCMDR
mdprc 066 09 17 001Philips HealthcareSureSigns VSi, SureSigns VS2+ monitorsNCMDR
mdprc 014 02 18 000Philips HealthcarePhilips HeartStart MRx and FR3 Monitor/Defibrillator NCMDR
mdprc 013 02 18 000GE HealthcareCentricity Universal Viewer with PACS-IW foundation 6.0 and Centricity PACS-IW with Universal ViewerNCMDR
mdprc 103 01 18 0003M Health Care Ltd3M™ Bair Hugger™ Full Access Underbody Warming Blanket NCMDR
mdprc 083 01 18 000Philips HealthcareIQon Spectral CT NCMDR
mdprc 077 01 18 000Ethicon Inc.ETHICON VICRYL RAPIDE™ SUTURE & ENDOLOOP® COATED VICRYL® SUTURE / ENDOLOOP® PDS® II SUTURENCMDR
mdprc 070 01 18 000Medtronic AFFINITY® NT Cardiotomy/Venous Reservoir (CVR) Stand-Alone NCMDR
mdprc 043 01 18 000Philips HealthcarePhilips IntelliVue Information Center (PIIC) iXNCMDR
mdprc 038 01 18 000GE HealthcareCARESCAPE Central Station (CSCS) NCMDR
mdprc 012 01 18 000Roche Diagnostics GmbHHematoxylin II and Horseradish Peroxidase reagentsNCMDR
mdprc 118 12 17 000Edwards LifesciencesClearSight Heart Reference SensorNCMDR
mdprc 116 12 17 000Roche Diagnostics Corpcobas u 601 / cobas u 701NCMDR
mdprc 115 12 17 000AbbottHemoglobin A1c (HbA1c) ReagentNCMDR
mdprc 114 12 17 000Beckman CoulterDuraClone B27 Reagent KitNCMDR
mdprc 113 12 17 000Boston ScientificSpyScope™ DSNCMDR
mdprc 112 12 17 000Philips HealthcareAllura Xper systems NCMDR
mdprc 098 12 17 000Medtronic Signia Power HandleNCMDR
mdprc 097 12 17 000Medtronic Medtronic Clip Gun™ Scalp Clip SystemNCMDR
mdprc 082 12 17 000Philips HealthcareBrightView, BrightView X, BrightView XCT, Precedence 6, Precedence 16NCMDR
mdprc 068 12 17 000Philips HealthcareAll Allura Xper, AlluraClarity, Allura CV, Allura Centron, UNIQ and Integris systemsNCMDR
mdprc 067 12 17 000AbbottARCHITECT DHEA‐S ReagentsNCMDR
mdprc 066 12 17 000AbbottCELL‐DYN Emerald 22 NCMDR
mdprc 065 12 17 000Medtronic SASynchroMed® II Implantable Drug InfusionNCMDR
mdprc 053 12 17 000GE HealthcareCARESCAPE R860 ventilator NCMDR
mdprc 051 12 17 000Boston ScientificMalecot Nephrostomy Catheter System, Malecot Nephrostomy Catheter Set, Re-Entry™ Malecot Nephrostomy Catheter Set and Percutaneous Access SetNCMDR
mdprc 008 07 17 001Abbott Laboratories IncARCHITECT c4000 Cuvette SegmentNCMDR
mdprc 043 12 17 000Bard Pcripheral Vascular (BPV)Balloon wall thickness of ATLAS® GOLD PTA Dilatation CatheterNCMDR
mdprc 042 12 17 000GE HealthcareLullaby Resus plus NCMDR
mdprc 001 12 17 000Elekta IncIVIEWGT SYSTEMNCMDR
mdprc 014 11 17 001Elekta Business Area Software Systems IMPAC Medical Systems Inc.Integrity 1.2NCMDR
mdprc 087 11 17 000Thermo Fisher Scientific Inc.Thermo Scientific Remel Shigella sonnei (Phases 1&2) Agglutinating SerumNCMDR
mdprc 083 11 17 000AbbottCELL-DYN RubyNCMDR
mdprc 082 11 17 000Beckman CoulteriQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100NCMDR
mdprc 062 11 17 000Medtronic SASynchroMed II Implantable Drug Infusion Pump.NCMDR
mdprc 061 11 17 0003M Health Care LtdBair Hugger Temperature Monitoring SensorsNCMDR
mdprc 005 09 17 003St. Jude Medical Inc.Accent/ Anthem, Accent MRI/ Accent ST, Assurity/ Allure and Assurity MRI deviceshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158781
mdprc 052 11 17 000Medtronic SASynchroMed II Implantable Drug Infusion Pump.NCMDR
mdprc 051 11 17 0003M Health Care LtdBair Hugger Temperature Monitoring SensorsNCMDR
mdprc 050 11 17 000Philips HealthcareBrilliance ICT, Brilliance iCT SP, lQon Spectral CTNCMDR
mdprc 015 11 17 000Elekta Business Area Software Systems IMPAC Medical Systems Inc.Agility 3.2NCMDR
mdprc 013 11 17 000Pro Med Instruments GmbHDORO Sterile Disposable Skull PinsNCMDR
mdprc 003 11 17 000Johnson & Johnson Vision CareACUVUE® OASYS® Brand Contact Lenses for ASTIGMATISM with HYDRACLEAR® PLUSNCMDR
mdprc 014 05 17 001Beckman CoulterAccess BR Monitor used with the Access Family of Immunoassay SystemsNCMDR, TGA :http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01360-1
mdprc 067 10 17 000Bio RadSalmonella AntiserumNCMDR
mdprc 066 10 17 000Medline Industries IncAplicare Povidone Iodine Prep PadsNCMDR
mdprc 054 10 17 001Fisher & Paykel Healthcare IncCatheter Mount Split Tubing CuffNCMDR
mdprc 053 10 17 000MedtronicCareLink iPro Therapy Management SoftwareNCMDR
mdprc 077 10 16 002St. Jude Medical IncFortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura and Unify QuadraNCMDR
mdprc 050 10 17 000GE Medical SystemsCarestation 620, 650 and 650c - Potential for Elevated FiCO2NCMDR
mdprc 049 10 17 000Philips HealthcareBrilliance 64, Ingenuity Core, Ingenuity Core 128, Ingenuity CTNCMDR
mdprc 031 10 17 000Elekta IncERGO++ and ERGO LocalizerNCMDR
mdprc 053 01 17 002Boston Scientific Model 3200 S-ICD programmerSwissmedic
mdprc 017 10 17 000Mobius Imaging, LLCAIRO Mobile CT Scanner.NCMDR
mdprc 016 10 17 000Philips BurtonPhilips Network, Cisco Adaptive Security Appliance (ASA) 5506 firewallNCMDR
mdprc 069 09 17 000Synthes GmbHDELTA XTEND Reverse Shoulder System Modular Centered and Eccentric Epiphysis ProsthesesNCMDR
mdprc 068 09 17 000Medtronic SACovidien GastriSail Gastric Positioning SystemNCMDR
mdprc 067 09 17 000Medtronic SANeuray Neurosurgical Patties and Strips and Merocel Neurosurgical Pattie and PackingNCMDR
mdprc 061 09 17 001Philips HealthcareBrilliance 64/ Ingenuity CT / Ingenuity Core / Ingenuity Core128NCMDR
mdprc 036 09 17 000Medtronic SAMiniMed Infusion SetsNCMDR
mdprc 004 09 17 000TRUMPF Medizin Systeme GmbH.Universal Arm SupportNCMDR
mdprc 079 03 17 001Medtronic SADBS Lead Depth StopNCMDR
mdprc 105 08 17 000Terumo Cardiovascular Systems CorporationOver-Pressure Safety ValvesNCMDR
mdprc 104 08 17 000Bio-Rad ID-DiaCellNCMDR
mdprc 001 08 17 001Roche Diagnostics CorpCobas 8000 core unitNCMDR
mdprc 086 08 17 000Philips Healthcare Gamma CamerasAllura Xper R9 and Azurion R1.1NCMDR
mdprc 081 08 17 000Randox Laboratories Ltd.Liquid Cardiac Control Level 3NCMDR
mdprc 080 08 17 000Randox Laboratories LtdImmunoassay Premium and Premium Plus Quality ControlsNCMDR
mdprc 040 08 17 000Medtronic SACovidien Emprint™ Percutaneous Antenna with Thermosphere™ TechnologyNCMDR
mdprc 039 08 17 000C R Bard IncARCTIC SUN® 5000 Temperature Management SystemNCMDR
mdprc 038 08 17 000Nucletron bvOncentra® BrachyNCMDR
mdprc 115 07 17 000Randox Laboratories Ltd.Liquid Urine Control Level 3NCMDR
mdprc 094 07 17 000BrainLABAiro Mobile CT scannerNCMDR
mdprc 071 07 17 000Roche Diagnostics Corpcobas c 501, 502 moduleNCMDR
mdprc 063 07 17 000Bio-Rad Medical DiagnosticsID-PapainNCMDR
mdprc 062 07 17 000Medtronic SAEuphora and Solarice Angioplasty catheter, balloon dilatationNCMDR
mdprc 057 07 17 000Philips HealthcarePhilips Brilliance iCTNCMDR
mdprc 056 07 17 000Stryker InstrumentsStryker System G handpiecesNCMDR
mdprc 032 07 17 000LivaNova PLCModel 105AspireHC and Model 106 AspireSR VNS Therapy GeneratorsNCMDR
mdprc 021 03 17 001Baxter HealthcarePrismaflex System, Prismaflex 4.11, Prismaflex 5.00 Row, Prismaflex 6.10 Row and Prismaflex 7.XX Row.NCMDR
mdprc 007 07 17 000IMPAC Medical Systems Inc. MOSAIQ Systems NCMDR
mdprc 006 07 17 000Leica Microsystems Inc.M720 + Protective Glass HolderNCMDR
mdprc 005 07 17 000Medtronic AxiEMTM ENT Suction instrumentsNCMDR
mdprc 004 07 17 000Medtronic Multiple Medtronic DLP productsNCMDR
mdprc 003 07 17 000Microgenics Corporation, part of Thermo Fisher ScientificMULTIGENT QuinidineNCMDR
mdprc 002 07 17 000National Biological CorpHand Foot II NCMDR
mdprc 001 07 17 000Stryker IVS Bone CementNCMDR
mdprc 075 06 17 000Baxter HealthcareAK 98, 230V, Bio NCMDR
mdprc 074 06 17 000BD BiosciencesModel 8015 Alaris System PC UnitsNCMDR
mdprc 073 06 17 000Boston ScientificEncore™ 26 Inflation Device Single PackNCMDR
mdprc 072 06 17 000EOS ImagingROTH MOBELI grab handles used with EOS SystemNCMDR
mdprc 071 06 17 000IMPAC Medical Systems Inc. MOSAIQ Radiation OncologyNCMDR
mdprc 065 06 17 000GE HealthcareCentricity Critical Care (CCC, formerly known as Clinisoft)NCMDR
mdprc 055 06 17 000Leica Microsystems, Inc.ASP6025 Tissue ProcessorNCMDR
mdprc 054 06 17 000Baxter Corp CanadaSharesource Claria Connectivity Platform for Use with Homechoice Claria APD SystemNCMDR
mdprc 070 08 16 001GE HealthcareInfant Warmer System (IWS) Hot “Heater Head”NCMDR
mdprc 048 06 17 000Abbott Laboratories IncMULTIGENT Creatinine (Enzymatic)NCMDR
mdprc 157 05 17 000Philips HealthcareThe DuraDiagnost systems NCMDR
mdprc 144 05 17 000D.O.R.C. Dutch Opthalmic Research CenterVFI Pack for Silicone Oil syringes.NCMDR
mdprc 141 05 17 000Medtronic SAMiniMed 640G Insulin Infusion Pump..NCMDR
mdprc 121 05 17 000Abbott Cardiovascular and NeuromodulationHeartMate 3 Left Ventricular Assist SystemNCMDR
mdprc 086 03 17 001SorinSorin Group perfusion system – Heater-cooler 1T, Heater-cooler 3T and FlexTherm devicesNCMDR
mdprc 086 05 17 000Medtronic NavLock Trackers Used with StealthStation SystemsNCMDR
mdprc 085 05 17 000Philips HealthcareModel V60 VentilatorsNCMDR
mdprc 080 05 17 000Roche Diagnostics Corpcobas® MPX and DPX Test, CE-IVDNCMDR
mdprc 078 05 17 000Medtronic Covidien 5 mm Endo Peanut DevicesNCMDR
mdprc 058 12 16 001Medtronic SAClaria MRI™ CRT-D SureScan™ and Amplia MRI™ CRT-D SureScan™NCMDR
mdprc 036 05 17 000C R Bard Inc.Caliber Inflation Device NCMDR
mdprc 016 05 17 000Philips HealthcarePhilips IntelliVue Neuromuscular Transmission Patient CableNCMDR
mdprc 015 05 17 000Philips HealthcareDigitalDiagnost 3.1.xNCMDR
mdprc 079 04 17 000SHANGHAI NINELUCK CO.LTDHot Water Bag with cover.NCMDR
mdprc 078 04 17 000Beckman CoulterAccess 2 Family of Immunoassay SystemsNCMDR
mdprc 073 04 17 000AbbottARCHITECT SHBG ReagentsNCMDR
mdprc 065 04 17 000Baxter Corp ARTIS 230V and ARTIS 230V PhysioNCMDR
mdprc 039 04 17 000Medtronic SANewport™ HT70 and Newport™HT70 Plus VentilatorsNCMDR
mdprc 027 04 17 000Bio RadMonolisa HCVNCMDR
mdprc 020 04 17 000Smith & NephewTecomet, OSTEOTOME BLADESNCMDR
mdprc 112 03 17 000Zimmer BiometZimmer Specific Knee, Hip and Nail ImplantsNCMDR
mdprc 095 03 17 000AbbottNC Trek RX Coronary Dilatation Catheter , NC Traveler RX Coronary Dilatation Catheter and NC Tenku RX PTCA Balloon CatheterNCMDR
mdprc 093 03 17 000Welcare Industries Easyderm wipesNCMDR
mdprc 080 03 17 000GE HealthcareVivid UltrasoundNCMDR
mdprc 074 03 17 000Smith & NephewDisposable Kits for Patient PositioningNCMDR
mdprc 073 03 17 000Philips HealthcareAllura Xper X-ray Systems NCMDR
mdprc 072 03 17 000Medtronic Curity™ Eye Pad Oval and Curity™ Sodium Chloride DressingNCMDR
mdprc 071 03 17 000Immucor GmbHCapture-R Ready-IDNCMDR
mdprc 070 03 17 000Immucor GmbHPanocell-20 NCMDR
mdprc 069 03 17 000BarcoMDRC-1119 displayNCMDR
mdprc 068 03 17 000Abbotti-STAT1 Analyzer Software , i-STAT Celite ACT cartridgesand i-STAT Kaolin ACT CartridgesNCMDR
mdprc 046 03 17 000OlympusSPL-G – SHOCKPULSE GENERATORNCMDR
mdprc 020 03 17 000Smith & NephewDYONICS Battery Power Hand PiecesNCMDR
mdprc 011 03 17 000Medtronic SAEndurant™ / Endurant II ™ 23mm and 25mm Bifurcated Stent Graft SystemsNCMDR
mdprc 113 02 17 000Roche Diagnostics Ltdcobas e 602 module and cobas e 801 module used with cobas® 8000 modular analyzer seriesNCMDR
mdprc 090 02 17 000Bio Rad.Liquichek Diabetes ControlNCMDR
mdprc 089 02 17 000Roche Diagnostics LtdCobas 8100 automated workflow seriesNCMDR
mdprc 087 02 17 000Draeger Medical Systems Inc. IACS monitoring, PulmoVista 500, Work Station Critical Care and Work Station Neonatal CareNCMDR
mdprc 058 02 17 000AbbottCELL‐DYN RubyNCMDR
mdprc 118 02 14 002Draeger Medical Systems IncOptional Power Supply Unit PS500, used in connection with multiple Draeger deviceshttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00176-1
mdprc 111 11 15 001shanghai channelmed import a export co.,ltdSTERILE GAUZE SWAB WITH X-RAY 4"X4"NCMDR
mdprc 112 11 15 001shanghai channelmed import a export co.,ltdSTERILE COTTON BALLSNCMDR
mdprc 028 02 17 000GE HealthcareRFX/SFX, Legacy, Precision 500D systemsNCMDR
mdprc 027 02 17 000Smith & NephewOSTEORAPTOR SUTURE ANCHOR WITH ULTRABRAID SUTURESNCMDR
mdprc 026 02 17 000Roche Diagnostics LtdElecsys TSH assay and Elecsys PTH assay used on cobas e 602 moduleNCMDR
mdprc 025 02 17 000Philips HealthcareEfficia CMS200 Central Monitoring SystemsNCMDR
mdprc 008 02 17 000Roche Diagnostics LtdElecsys® Anti-HAVNCMDR
mdprc 007 02 17 000Bio Rad.Platelia™ Aspergillus Ag assayNCMDR
mdprc 139 01 17 000Medtronic SAStrata™ II/Strata™ NSC Valves (including Burr Hole and Lumbar Peritoneal [LP]) Valve Magnet Reverse Polarity (Excludes StrataMR™)NCMDR
mdprc 135 01 17 000SumiReinfirced tracheal tube without/with cuff, Size 2mm, 2.5mm, 3mmNCMDR
mdprc 125 01 17 000Schiller AGCARDIOVIT AT-102 PlusNCMDR
mdprc 116 01 17 000GE HealthcareDiscovery MR450 narrow bore 1.5T MRI NCMDR
mdprc 050 01 17 000Philips HealthcarePhilips BrightView XCT and BrightView X NCMDR
mdprc 049 01 17 000Molnlycke Health Care AB.ProcedurePak® trays containing "Swab Gauze XRD 30x30 18plyNCMDR
mdprc 037 01 17 000Smith & NephewHD1200 AUTOCLAVABLE CAMERA HEAD AND HD1200 AUTOCLAVABLE CAMERA CONTROL UNITSNCMDR
mdprc 036 01 17 000MAQUET CARDIOSAVE Hybrid IABP and Maquet CARDIOSAVE Rescue IABPNCMDR
mdprc 064 10 16 001Covidien LLCCovidien Devon Light Gloves..NCMDR
mdprc 010 01 17 000FUJIFILM Medical SystemsED-530 XT and ED-530XT8 DuodenoscopesNCMDR
mdprc 085 12 16 000Boston Scientific LtdImager II Angiographic CatheterNCMDR
mdprc 066 12 16 000Baxter CorpCentral Water Plant (CWP) Reverse Osmosis UnitsNCMDR
mdprc 065 12 16 000BrainLABiPlan RT and iPlan RT Dose , BrainSCANNCMDR
mdprc 064 12 16 000Philips HealthcarePhilips DuraDiagnost & DuraDiagnost Compact X-ray systemNCMDR
mdprc 057 12 16 000Alphatec Spine IncSamarys RFNCMDR
mdprc 077 10 15 001Beckman CoulterCOULTER Body Fluid Control Level 1NCMDR
mdprc 023 12 16 000Yafho Bio - Technology CO. LtdULTRASOUND PROBE COVER KIT WITH GELNCMDR
mdprc 001 12 16 000GE HealthcarePrestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systemsNCMDR
mdprc 127 11 16 000AbbottARCHITECT Toxo IgMNCMDR
mdprc 072 11 16 000Unimed Surgical Products, IncUnicryl, Unicaprone, Unicryl Quick, Uniglactin, Unicryl MNCMDR
mdprc 062 11 16 000Teleflex MedicalARROW OnControl Biopsy System TrayNCMDR
mdprc 041 11 16 000Randox Laboratories Ltd.CK NacNCMDR
mdprc 040 11 16 000PENTAX MedicalPENTAX Medical 9310HD Digital Video CaptureNCMDR
mdprc 039 11 16 000Gambro Lundia ABAK 98, 230V, BioNCMDR
mdprc 001 11 16 000GE HealthcareAvance CS2, Avance, and Amingo SystemNCMDR
mdprc 082 03 14 002Medtronic SynchroMed® II Implantable Drug Infusion PumpNCMDR
mdprc 126 10 16 000Medtronic SAMeddtronic Model 37751 Recharger included in Model 37651 Charging SystemNCMDR
mdprc 125 10 16 000GE HealthcareInnova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ, Cardiovascular X-ray imaging systemsNCMDR
mdprc 124 10 16 000GE HealthcareLullaby WarmerNCMDR
mdprc 105 10 16 000B Braun Medical Inc.Dialog+ Dialysis Machines with Software 8.2A and Option AdimeaNCMDR
mdprc 098 10 16 000AbbottARCHITECT Lactic AcidNCMDR
mdprc 097 10 16 000Philips HealthcareAchieva 3.0T and Ingenia 3.0T MR systems with passive shielding in the rear wall.NCMDR
mdprc 079 10 16 000Medtronic SAClearify Visualization SystemNCMDR
mdprc 078 10 16 000Medtronic SAPipeline Embolization Device (Pipeline Classic), Alligator Retrieval Device, Xcelerator Hydrophilic Guidewire, UltraFlow HPC Flow Directed Microcatheter, Marathon Flow Directed MicrocatheterNCMDR
mdprc 038 10 16 000StrykerPowerPRO Ambulance Cots.NCMDR
mdprc 032 10 16 000Smith & NephewSUCTION PUNCHNCMDR
mdprc 043 09 16 000C R Bard IncARCTIC SUN Temperature Management System.NCMDR
mdprc 042 09 16 000RESEARCH INSTRUMENTS LTDEZ-StripNCMDR
mdprc 014 09 16 000Welch Allyn Protocol IncMS3 Connex Spot Classic Mobile Stand & Power SupplyNCMDR
mdprc 013 09 16 000GE HealthcareMAGiC on Signa Pioneer and systems running Application software version DV25.1.NCMDR
mdprc 010 09 16 000GE HealthcareSIGNA Creator and SIGNA ExplorerNCMDR
mdprc 007 09 16 000Smith & NephewTANDEM™ BIPOLAR HIP SYSTEMNCMDR
mdprc 036 08 16 001Medtronic SAEnVeo R Delivery Catheter Systemhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01015-1
mdprc 071 08 16 000Aspen Surgical Products, Inc..Sorbsan Calcium Alginate Dressings (Flat, Ribbon, Packing, Plus and Border) and Sorbsan Silver Calcium Alginate Dressing (Flat)NCMDR
mdprc 069 08 16 000Medtronic SAViva Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) and Evera Implantable Cardioverter Defibrillators (ICDs)NCMDR
mdprc 046 08 16 000GE HealthcareMerge Healthcare CADstreamNCMDR
mdprc 145 07 16 000Hologic IncDimensions 8000 Acquisition WorkstationNCMDR
mdprc 143 07 16 000Philips HealthcarePhilips IntelliVue Patient Monitors.NCMDR
mdprc 139 07 16 000Medtronic SAO-arm® 1000 and O-arm® O2 Surgical Imaging SystemsNCMDR
mdprc 138 07 16 000DeRoyal Industries Inc.DeRoyal Isolation BagNCMDR
mdprc 018 04 16 002AbbottCELL-DYN Emerald Cleaner .BfArM
mdprc 037 07 16 000Biokit S AQuantia Digitoxin ReagentNCMDR
mdprc 013 07 16 000Saudi Mais for Medical ProductsUrine drainage bag with sampling portNCMDR
mdprc 111 06 16 000Hitachi Medical CorpAIRIS Vento, APERTO LucentNCMDR
mdprc 110 06 16 000Philips HealthcarePhilips DuraDiagnost X-ray system .NCMDR
mdprc 109 06 16 000Philips HealthcareAllura Xper R8.2 and UNIQ R1.0 X-ray SystemsNCMDR
mdprc 098 06 16 000Medtronic SANeuromodulation Deep Brain Stimulation (DBS) system pocket adaptorsNCMDR
mdprc 074 06 16 000Medtronic SATemporary Transvenous Pacing Lead SystemNCMDR
mdprc 002 06 16 000Ethicon Endo Surgery IncETHICON PHYSIOMESH Flexible Composite MeshNCMDR
mdprc 001 06 16 000GE Healthcare3.0T 6-Channel Flex Coils Used with Discovery MR750 3.0T Scanners Running DV24, DV25, or DV25.1 Application SoftwareNCMDR
mdprc 138 05 16 001AbbottACCELERATOR Automated Processing System (APS)NCMDR
mdprc 137 05 16 000Medtronic IncPSS Midas Rex Sagittal SawsNCMDR
mdprc 104 05 16 000Medtronic Advanced Energy, LLCDBS Tunneling ProcedureNCMDR
mdprc 103 05 16 000Medtronic Advanced Energy, LLCDeep Brain Stimulation TherapyNCMDR
mdprc 102 05 16 000GE HealthcareRevolution CT systemsNCMDR
mdprc 064 05 16 000Intuitive Surgical Incda Vinci Xi Universal SealNCMDR
mdprc 057 05 16 000Medtronic Cardiovascular Revascularization & Surgical TherapNeurostimulator system for pain therapyNCMDR
mdprc 028 05 16 000Philips HealthcareMX 16-slice CT SystemsNCMDR
mdprc 027 05 16 000AB SCIEX Pte. Ltd4500MD Mass SpectrometerNCMDR
mdprc 026 05 16 000Philips HealthcareDigitalDiagnost systemsNCMDR
mdprc 137 04 16 0003M Health Care Ltd3M Ranger High Flow Disposable SetNCMDR
mdprc 136 04 16 000AbbottARCHITECT STAT High Sensitive Troponin-I Reagent .NCMDR
mdprc 120 04 16 000GE HealthcareDiscovery IGS 730 & Discovery IGS 740 systems .NCMDR
mdprc 091 04 16 000Beckman CoulterDxH 800, DxH 600, and DxH Slidemaker StainerNCMDR
mdprc 090 04 16 000C R Bard IncHickman and Leonard Central Venous Catheter KitsECRI, NCMDR
mdprc 089 04 16 000Philips HealthcareMobileDiagnost wDR 2NCMDR
mdprc 094 03 16 001Philips HealthcareAutoSPECT Pro reconstruction application on: IntelliSpace PortalBfArM
mdprc 050 04 16 000Philips HealthcareJuno DRF .NCMDR
mdprc 049 04 16 000Trumpf Medical Systems, Inc.Universal Arm SupportNCMDR
mdprc 029 04 16 000Philips HealthcarePhilips EPIQ Ultrasound System .NCMDR
mdprc 028 04 16 000Elekta IncLeksell Gamma Knife Perfexion and Leksell Gamma Knife IconNCMDR
mdprc 019 04 16 000Stryker NeurovascularGDC 360 Detachable CoilsNCMDR
mdprc 017 04 16 000AbbottARCHITECT Estradiol ReagentNCMDR
mdprc 164 03 16 000AB SCIEX Pte. LtdAnalyst MD SoftwareNCMDR
mdprc 163 03 16 000B Braun Medical IncDialog machines and Dialog+ machinesNCMDR
mdprc 162 03 16 000Becton Dickinson & Co. (BD)BD Angiocath TM AutoguardTM shielded IV CatheterNCMDR
mdprc 161 03 16 000Schiller AGFRED EasyportNCMDR
mdprc 144 03 16 000BarcoColor Monitor (P19STv)NCMDR
mdprc 143 03 16 000Covidien LLCCurity™ All Purpose Gauze Sponges, Curity™ X-Ray Detectable Laparotomy Sponges, Kerlix™ X-Ray Detectable Laparotomy Sponges, Vistec™ X-Ray Detectable SpongesNCMDR
mdprc 142 03 16 000Elekta Inc..leksell Gamma Knife® Perfexion™ and Leksell Gamma Knife® Icon™ systemsNCMDR
mdprc 141 03 16 000GE HealthcareAisys family of Anesthesia devices .NCMDR
mdprc 098 03 16 000AbbottARCHITECT T-Uptake CalibratorsNCMDR
mdprc 097 03 16 000Beckman CoulterDxH 500, PN B40601NCMDR
mdprc 096 03 16 000DexCom IncDexcom G4 PLATINUM and Dexcom G5 Receivers.NCMDR
mdprc 095 03 16 000Intuitive Surgical Incda Vinci Si and Xi Touchpad Compact Flash CardNCMDR
mdprc 043 03 16 000Philips HealthcareAutoSPECT Pro Reconstruction application on Extended Brilliance Workspace NM software version 2.0NCMDR
mdprc 042 03 16 000StrykerPositionPRO Mattress .NCMDR
mdprc 070 02 16 0003M Health Care Ltd3M Steri-Vac™ Gas Sterilizer/AeratorNCMDR
mdprc 069 02 16 000Bio-Rad Laboratories IncAutoimmune EIA Anti-Sm/RNPNCMDR
mdprc 068 02 16 000GE HealthcareAisys CS2 and Upgraded Aisys DevicesNCMDR
mdprc 040 02 16 000Bio-Rad Laboratories IncVARIANT II TURBO HbA1c Kit - 2.0 analytical cartridgeNCMDR
mdprc 039 02 16 000Bio-Rad Laboratories IncLiquichek Specialty Immunoassay ControlNCMDR
mdprc 038 02 16 000GE Healthcare3.0T GEMflex CoilNCMDR
mdprc 037 02 16 000Synthes IncUniversal Femoral NailsNCMDR
mdprc 011 02 16 000SMI A.G.SMI surgical suturesNCMDR
mdprc 010 02 16 000GE HealthcareGE Healthcare CT and PET Service Manual Update NoticeNCMDR
mdprc 009 02 16 000Accuray IncCyberKnife® Robotic Radiosurgery Systems limited to certain G4, VSI, and G3 systemsNCMDR
mdprc 008 02 16 000Abbott Laboratories IncARCHITECT STAT High Sensitive Troponin-I Reagent KitNCMDR
mdprc 098 01 16 000Leica Microsystems Inc.Leica M525 OH4 and Leica M720 OH5NCMDR
mdprc 097 01 16 000Beckman Coulter iChemVELOCITY Automated Urine Chemistry System.NCMDR
mdprc 062 06 14 001Baxter HealthcareABACUS Total Parenteral Nutrition (TPN) Calculation SoftwareNCMDR
mdprc 073 01 16 000IBA Dosimetry GmbHElectrical lift tableNCMDR
mdprc 072 01 16 000Philips HealthcareTrilogy 100, Trilogy 200, Garbin, Garbin Plus, Trilogy O2, Trilogy 202, Trilogy ECNCMDR
mdprc 071 01 16 000Baxter HealthcareHomeChoice/HomeChoice PRO Automated PD deviceNCMDR
mdprc 051 01 16 000Bio Rad.D-10 Rack LoaderNCMDR
mdprc 050 01 16 000Medtronic SASpecify 5-6-5 Surgical Lead and Specify 2x8 Surgical LeadNCMDR
mdprc 049 01 16 000Philips HealthcareIntelliVue Measure Modules Used with IntelliVue Patient MonitorsNCMDR
mdprc 048 01 16 000Schiller AGFRED easyNCMDR
mdprc 042 01 16 000DePuySynthesExtraction Screw for PFNA BladeNCMDR
mdprc 033 01 16 000GE HealthcareGE PRN 50-M+ Digital WritersNCMDR
mdprc 125 12 15 000B Braun Medical IncCERTOFIX QUATTRONCMDR
mdprc 124 12 15 000Beckman CoulterCOULTER S-CAL Calibrator KitsNCMDR
mdprc 123 12 15 000Acist Medical SystemsBT2000 and CPT2000 Manifold KitsNCMDR
mdprc 122 12 15 000Bayer Healthcare LLC.Nova T 200 IUDNCMDR
mdprc 121 12 15 000GE HealthcareDrive Gas Check Valve of certain Anesthesia products.NCMDR
mdprc 036 04 14 001Philips Healthcare-Brilliance CT series (6, 10, 16, 16 Power, 40, 64, Big Bore, iCT, iCT SP), Ingenuity CT, Ingenuity Core, Ingenuity Core128, Ingenuity Flex, and MX8000 Dual v. EXPNCMDR
mdprc 114 12 15 000Zimmer incNexGen Precoat Tibial Plate, NexGen Option Tibial PlateNCMDR
mdprc 096 12 15 000Cyberonics IncModel 106 AspireSR® VNS Therapy® generatorNCMDR
mdprc 095 12 15 000GE HealthcareOptima XR200amx, Optima XR220amx and Brivo XR285amx X-ray imaging systemsNCMDR
mdprc 094 12 15 000SCIENT’XSamarys deviceNCMDR
mdprc 068 12 15 000Philips HealthcareAllura Xper systems FD20NCMDR
mdprc 052 09 15 002Philips HealthcareAllura Xper FDNCMDR, MHRA
mdprc 034 12 15 000Cook MedicalVentriClear® II Ventricular Drainage Catheter SetNCMDR
mdprc 030 12 15 000Covidien Endo GIA™ Ultra Universal Stapler HandlesNCMDR
mdprc 029 12 15 000Intuitive Surgical Incda Vinci® Xi™ endoscope and cannulae configurationsNCMDR
mdprc 124 11 15 000Boston Scientific Cardiac Rhythm Management GroupIntellaTip MiFi™ XP Asymmetric (N4) Curve Temperature Ablation CathetersNCMDR
mdprc 115 11 15 001Philips HealthcareAllura Xper FD R8.2.0NCMDR
mdprc 116 11 15 000B Braun Surgical SACellistypt, Cellistypt D-K and Cellistypt FNCMDR
mdprc 080 11 15 000Medtronic IncInSync® III Cardiac Resynchronization Therapy Pacemakers (CRT-P)NCMDR
mdprc 050 11 15 000Philips HealthcareAllura Xper FD R2.xNCMDR
mdprc 049 11 15 000Philips HealthcareAll Allura Xper, AlluraClarity, Allura CV, Allura Centron and UNIQ systemsNCMDR
mdprc 048 11 15 000St. Jude Medical IncOptisure™ Dual Coil Defibrillation LeadsNCMDR
mdprc 028 11 15 000StrykerStryker 2-Stage and 3-Stage I.V. PolesNCMDR
mdprc 004 11 15 001B Braun Medical IncA/V Set DEHP-free PVC for DialogBfArM
mdprc 003 11 15 000Getinge Disinfection ABED FLOW and POKA YOKENCMDR
mdprc 076 10 15 000Beckman CoulterUniCel DxH 800 & 600 COULTER Cellular Analysis SystemsNCMDR
mdprc 075 10 15 000Beckman CoulterUniCel DxH Slidemaker Stainer COULTER Cellular Analysis SystemsNCMDR
mdprc 074 10 15 000eVent MedicalInspiration Ventilator System ..NCMDR
mdprc 073 10 15 000Philips HealthcareHeartStart MRx Defibrillator/Monitor with software versions F.03.06 and T.00.05NCMDR
mdprc 072 10 15 000Stryker Instruments.Triathlon MIS Modular Distal CaptureNCMDR
mdprc 071 10 15 000Philips HealthcarePhilips HeartStart MRx Monitor/Defibrillator with Q-CPRNCMDR
mdprc 070 10 15 000Philips HealthcareBrilliance 16-Slice (Air), Brilliance 64 CT, Ingenuity Core, Ingenuity Core 128, Brilliance CT Big Bore, Ingenuity FlexNCMDR
mdprc 069 10 15 000Advanced Sterilization ProductsSTERRAD NX Sterilization SystemNCMDR
mdprc 031 10 15 000Varian Medical SystemsARIA for Radiation OncologyNCMDR
mdprc 026 06 15 001Medtronic IncMedtronic Navigation Cannulated TapsNCMDR
mdprc 030 10 15 000GE HealthcareCentricity PACS-IW with Universal Viewer and Centricity Universal Viewer ..NCMDR
mdprc 003 10 15 000Welch Allyn KleenSpec Corded illumination SystemNCMDR
mdprc 040 08 15 002GE HealthcareCentricity PACS IW with Universal Viewer Version 5.0 and Centricity Universal Viewer Version 6.0 productsNCMDR
mdprc 121 09 15 000GE HealthcareMR Surgical Suite II Table Transfer ReleaseNCMDR
mdprc 120 09 15 000SENTINEL CH. SpAAmmonia Ultra ReagentNCMDR
mdprc 095 09 15 000Baxter HealthcareEXACTAMIX compounderNCMDR
mdprc 004 09 15 000GE HealthcareMultiple 3.0T MR systemsNCMDR
mdprc 003 09 15 000Advanced Sterilization ProductsGLOSAIR™ 400 CartridgeNCMDR
mdprc 210 08 15 000Elekta IncXiO Radiation Treatment Planning SystemsNCMDR
mdprc 209 08 15 000Boston Scientific CorporationWATCHMAN® Left Atrial Appendage Closure Device with NCMDR
mdprc 171 08 15 000Advanced Sterilization ProductsCIDEX® OPA Solution Instructions For UseNCMDR
mdprc 160 08 15 000Medtronic IncTRITON™ Pneumatic High Torque Hand Piece HoseNCMDR
mdprc 159 08 15 000Stryker Instruments.NEPTUNE® 2 WASTE MANAGEMENT SYSTEM, Actuator AssembliesNCMDR
mdprc 015 08 15 001Covidien LLCPuritan Bennett™ 980 Series Ventilator System For Universal and Neonatal ModelsNCMDR, BfArM
mdprc 039 08 15 000Arrow International IncARROW® International PICC Kits with Peel-Away Sheath ComponentNCMDR
mdprc 038 08 15 000Medtronic IncActiva® PC, Activa® SC, Activa® RC, Activa® PC+S, Kinetra®, and Soletra®NCMDR
mdprc 037 08 15 000pfm medical agNit-Occlud Implantation SheathNCMDR
mdprc 063 07 15 000AbbottARCHITECT B12 Reagent kitNCMDR
mdprc 062 07 15 000GE Healthcareimtmedical AG, EVair Compressor (an optional accessory to GE Healthcare Engstrom Carestation, Engstrom Pro, and CARESCAPE R860 ventilators)NCMDR
mdprc 060 07 15 000Baxter HealthcarePrismaflex control unit, SW7.xxNCMDR
mdprc 059 07 15 000Molnlycke Health Care ABProcedurePak traysNCMDR
mdprc 108 04 15 001Advanced Sterilization ProductsCIDEX® OPA Solution Test StripsNCMDR
mdprc 033 07 15 000Maquet Cardiopulmonary AGHeater-Cooler Unit HCU 40 High VoltageNCMDR
mdprc 136 04 13 001BrainLABBrainlab Cranial Navigation Systemhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2015-RN-00558-1
mdprc 151 06 15 000Philips HealthcareAllura CV20NCMDR
mdprc 150 06 15 000BIOTRONIK UK LtdOrsiro ,Sirolimus Eluting Coronary Stent SystemNCMDR
mdprc 142 06 15 000Zimmer incJava Hook Implants, Instruments, and ContainersNCMDR
mdprc 102 06 15 000GE HealthcarePrecision 500D Radiographic and Fluoroscopic (R&F) Systems Advantx Legacy/Legacy-D Radiographic and Fluoroscopic (R&F) SystemsNCMDR
mdprc 101 06 15 000GE Healthcaresingle and dual LCD monitor suspensions used on Precision 500D classical radiographic and fluoroscopic (R&F) systems, Precision RXi 23A/32A analog systems, Precision RXi digital systems and Precision MPi fluoroscopic imaging systems.NCMDR
mdprc 100 06 15 000Medtronic IncDLP Femoral Arterial Cannula, DLP Femoral Cannula and Insertion KitNCMDR
mdprc 061 06 15 000Philips HealthcareMobileDiagnost wDR 1 and 2NCMDR
mdprc 059 06 15 000Alcon Laboratories Inc.Accurus Standalone ProbeNCMDR
mdprc 026 05 15 001Kimal plcDevon Light Glove included in various Kimal Procedure PacksNCMDR, MHRA
mdprc 018 06 15 000AI DE DIAGNOSTIC CO., LTD.First Step PlusNCMDR
mdprc 007 06 15 000Elekta IncOncentra Brachy versions 3.x (excluding v3.0) and 4.xNCMDR
mdprc 086 05 15 000Covidien LLCOxiMax N-65 Handheld Pulse Oximeters & OxiMax N-560 Pulse OximetersNCMDR
mdprc 068 05 15 000AbbottAlkaline WashNCMDR
mdprc 107 11 14 002Medtronic Inc3f Enable Aortic BioprosthesisNCMDR
mdprc 054 05 15 000SoluscopeSOLUSCOPE SERIE 4 PANCMDR
mdprc 053 05 15 000Spacelabs Healthcare IncUltraview SL Command Modules ..NCMDR
mdprc 052 05 15 000AbbottSekisui Diagnostics Acetaminophen ReagentNCMDR
mdprc 027 05 15 000Diamed GmbHDAT IgG-DilutionNCMDR
mdprc 025 05 15 000SHANGAHI CHANNELMED IMPORT & EXPORT CO LTD.Hot Water BottleNCMDR
mdprc 125 04 15 000Philips HealthcareEsprit V1000 and Esprit/V200 Conversion VentilatorNCMDR
mdprc 107 04 15 000GE HealthcareCentricity PACS-IWNCMDR
mdprc 106 04 15 000GE HealthcareCentricity PACS-IW with Universal ViewerNCMDR
mdprc 105 04 15 000Medtronic IncNeuromodulation Deep Brain Stimulation (DBS) system extensionsNCMDR
mdprc 067 04 15 000Baxter Corp CanadaINTERLINK System Non-DEHP T-Connector Extension SetsNCMDR
mdprc 066 04 15 000GE HealthcareD-Fend/D-Fend+ water traps used with Compact Airway Modules E/M-C(Ai)O(V)(X) and Cardiocap/5 monitorsNCMDR
mdprc 001 04 15 000Nobel BiocareNobel dental implant, NobelReplaceNCMDR
mdprc 136 03 15 000Natus Medical Inc.neoBLUE Blanket SystemsNCMDR
mdprc 123 03 15 000LAAx, Inc.TIGERPAW System II –7 & 9 connector configurationsNCMDR
mdprc 122 03 15 000US EndoscopyTalon® grasping deviceNCMDR
mdprc 106 03 15 000Baxter HealthcareHomeChoice & HomeChoice ProNCMDR
mdprc 105 03 15 000AUXILIARY AUXILIARY O2 AND SUCTION MODULE (FLOW-i)NCMDR
mdprc 103 03 15 000Intuitive Surgical IncVacuum Source Tubing Set, Stabilizer 5-Pack, used with da Vinci S and Si Surgical SystemsNCMDR
mdprc 086 03 15 000Medtronic Model 5392 Dual‐Chamber External Pulse GeneratorNCMDR
mdprc 045 03 15 000GE HealthcareSoftware Version: GE Healthcare MRI systemsNCMDR
mdprc 119 12 14 001Elekta LimitedMonaco, Radiotherapyhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=133680
mdprc 017 03 15 000AbbottARCHITECT Anti-HBc II Reagent KitNCMDR
mdprc 117 02 15 000BIOTRONIK UK LtdPasseo-18, Peripheral balloon catheterNCMDR
mdprc 028 02 15 000bioMerieux IncVIDAS ProgesteroneSwissmedic
mdprc 027 02 15 000Rayner Intraocular Lenses LtdT-flex AsphericSwissmedic
mdprc 026 02 15 000Baxter HealthcareSyringe Tip CapSwissmedic
mdprc 025 02 15 000Baxter HealthcareEasySpray Pressure Regulator, Tissomat and DuploSpray MIS Pressure RegulatorSwissmedic
mdprc 055 12 14 001GE HealthcareProteus XR/a X-ray imaging systemsNCMDR
mdprc 016 02 15 000GE HealthcareMagnetic Resonance Imaging SystemsNCMDR
mdprc 011 02 15 000Philips HealthcareMultiDiagnost Eleva .NCMDR
mdprc 122 01 15 000GE HealthcareEngstrom Carestation and Engstrom Pro ventilatorsNCMDR
mdprc 120 01 15 001Baxter HealthcareMiniCap with Povidone-Iodine SolutionNCMDR
mdprc 074 01 15 000Baxter HealthcarevP1.7 COLLEAGUE Pump.NCMDR
mdprc 048 01 15 000Elekta LimitedDigital Linear AcceleratorNCMDR
mdprc 047 01 15 000Medtronic IncInterStim, InterStim II, Itrel3 and EnterraNCMDR
mdprc 025 01 15 000Philips HealthcarePhilips HeartStart MRx Monitor/Defibrillator ..NCMDR
mdprc 024 01 15 000Philips HealthcarePhilip’s Anesthesia MachinesNCMDR
mdprc 023 01 15 000Philips HealthcarePhilip’s Anesthesia Machines ..NCMDR
mdprc 022 01 15 000Philips HealthcareBrilliance CT 16 Air, 64, Big Bore, ICT, iCT SP, Ingenuity CT, Ingenuity Core, Ingenuity Core 128 and Ingenuity FlexNCMDR
mdprc 001 12 14 001Philips HealthcareEPIQ 7 Ultrasound SystemNCMDR
mdprc 040 12 14 000Hospira IncHospira Plum Blood SetsNCMDR
mdprc 006 12 14 000Philips HealthcarePhilips HeartStart MRx Monitor/Defibrillator,NCMDR
mdprc 005 12 14 000Philips HealthcarePhilips M1783A and M5526A Sync CablesNCMDR
mdprc 004 12 14 000Unomedical A/SInfusion sets: Comfort, Comfort Short and Contact Detach, MiniMed Silhouette and MiniMed Sure-T infusion sets.NCMDR
mdprc 003 12 14 000Philips HealthcarePhilips HeartStart MRx Monitor/Defibrillator..NCMDR
mdprc 002 12 14 000Philips HealthcareHeartStart MRx monitor/defibrillatorsNCMDR
mdprc 108 06 14 001Philips HealthcareGel-E Donut and Squishon 2 Soft Gel PillowsNCMDR
mdprc 033 11 14 000Diamed GmbHIH-1000NCMDR
mdprc 032 11 14 000Philips HealthcareIntelliSpace Critical Care & AnesthesiaNCMDR
mdprc 031 11 14 000Baxter HealthcareHomeChoice and HomeChoice PRO Automated Peritoneal DialysisNCMDR
mdprc 014 11 14 000Alshifa Medical Syringes Manufacturing CompanyRAMY 0.5ml, 1ml, 5ml and 10ml insulin syringesNCMDR
mdprc 084 10 14 000Arjo HuntleighCarendo Hygiene ChairsNCMDR
mdprc 083 10 14 000Mortara Instrument, Inc.Mortara Surveyor S12 and Surveyor S19 Patient MonitorsNCMDR
mdprc 082 10 14 000Intuitive Surgical IncEndoWrist One Vessel SealerNCMDR
mdprc 008 09 14 002DiaSorin IncLIAISON TgNCMDR
mdprc 054 10 14 000Philips HealthcarePHILIPS MX 16-slice CT SystemNCMDR
mdprc 053 10 14 000Baxter HealthcareFLOSEAL HEMOSTATIC MATRIX (FLOSEAL VH S/D)NCMDR
mdprc 001 10 14 000Philips HealthcareAllura Xper SystemsNCMDR
mdprc 052 09 14 000AbbottARCHITECT Total T3 Reagent KitNCMDR
mdprc 129 08 14 001GE HealthcarePatient Data Module (PDM) and CARESCAPE Monitor Bx50 (B850, B650, or B450)NCMDR
mdprc 028 09 14 000Philips Medical Systems MobileDiagnost wDR X-Ray SystemsNCMDR
mdprc 138 08 14 000Draeger Medical Systems IncBabytherm 8004/8010 and Babytherm 8000WBNCMDR
mdprc 095 08 14 000Maquet Cardiopulmonary AGACROBAT V and ACROBAT SUV Systems and the XPOSE 3 and XPOSE 4 DevicesNCMDR
mdprc 093 08 14 000Baxter HealthcareDURA-GUARD, PERI-GUARD, and VASCU-GUARDNCMDR
mdprc 091 08 14 000Elekta LimitedPrecise Treatment TableNCMDR
mdprc 075 08 14 001Philips HealthcareIntelliSpace Portal Software Versions 5 and 6http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129099
mdprc 074 08 14 000Philips HealthcareIntelliSpace PACS 4.4NCMDR
mdprc 060 08 14 000DiaSorin IncLiaison Biotrin Parvovirus B19 IgMNCMDR
mdprc 058 08 14 000Elekta LimitedMonaco, treatment planning systemNCMDR
mdprc 017 08 14 000GE HealthcareCorometrics 174 series monitorsNCMDR
mdprc 003 08 14 000AbbottClinical Chemistry ICT Serum CalibratorNCMDR
mdprc 096 07 14 000Radiometer MedicalAnti-Virus Scan ToolNCMDR
mdprc 078 07 14 000Philips HealthcareExpression IP5 Information PortalNCMDR
mdprc 077 07 14 000Medtronic IncAscenda Intrathecal Catheters / Revision KitNCMDR
mdprc 070 07 14 000Vascutek LimitedGelweave, Thoraflex Hybrid, BioValsalva Stentless Biplex, Stented BioValsalva Biplex and RVOT elan BiplexNCMDR
mdprc 046 07 14 000Philips HealthcareAllura Xper R8.2.ONCMDR
mdprc 045 07 14 000Philips HealthcareIntelliSave AX700NCMDR
mdprc 014 07 14 000Intuitive Surgical IncLarge Clip Applier for use with the da Vinci S and da Vinci SiNCMDR
mdprc 013 07 14 000Varian Medical SystemsC-Series High Energy Linear AcceleratorsNCMDR
mdprc 012 07 14 000GE HealthcareCARESCAPE RespiratoryNCMDR
mdprc 011 07 14 000Hospira IncPlum A+ infusion pumpsNCMDR
mdprc 010 07 14 000Philips HealthcareBrightView XCT and BrightView X- upgraded with the XCT Flat Panel DetectorNCMDR
mdprc 107 06 14 000Philips Medical Systems Nederland B.V.DuraDiagnost X-ray SystemNCMDR
mdprc 106 06 14 000Stryker CommunicationsSTRYKER CUTTING ACCESSORIES (used with Elite Attachments)NCMDR
mdprc 063 06 14 000Johann Stiegelmeyer & Co GmbHTransport StretcherNCMDR
mdprc 029 06 14 000The Anspach Effort, Inc.STERRAD 100S Hydrogen Peroxide Gas Plasma Technology (STERRAD® 100S) for sterilization.NCMDR
mdprc 011 06 14 000Elekta LimitedHexaPOD evo RT System; iGUIDE 2.0NCMDR
mdprc 126 05 14 000GE HealthcareCARESCAPE Monitor B650NCMDR
mdprc 125 05 14 000Elekta LimitedMOSAIQ SoftwareNCMDR
mdprc 086 05 14 000Elekta LimitedMOSAIQ Couch Move Assistant (CMA)NCMDR
mdprc 078 05 14 000AbbottARCHITECT EBV VCA IgM ControlsNCMDR
mdprc 102 02 14 001Philips HealthcareHeartStart MRx monitor/defibrillators with Q-CPR metersNCMDR, MHRA
mdprc 007 05 14 000AbbottHemoglobin A1c (HbA1c) CalibratorsNCMDR
mdprc 144 04 14 000GE HealthcareGiraffe and Panda Warmers with Nellcor SpO2 SensorsNCMDR
mdprc 143 04 14 000GE HealthcareCompact Airway Gas Modules, E-C(Ai)O(V)(X)NCMDR
mdprc 128 04 14 000Elekta LimitedHexaPOD evo RT Couchtop Securing ScrewsNCMDR
mdprc 100 04 14 000Hospira IncInfusion Pump, Various Irrigation and Extension SetsNCMDR
mdprc 099 04 14 000Philips HealthcareDameca MRI 508 Anesthesia SystemsNCMDR
mdprc 098 04 14 000Philips HealthcareLithium Ion Battery M4605A and M4607A for use with IntelliVue Patient MonitorsNCMDR
mdprc 088 04 14 000Philips HealthcareMobileDiagnost wDRNCMDR
mdprc 080 04 14 000AbbottReagent for LipaseNCMDR
mdprc 053 04 14 000Philips HealthcareBrilliance Workspace Portal software version 2.6.1.4NCMDR
mdprc 035 04 14 000Philips HealthcareDefibrillator/Monitor , HeartStartXL+NCMDR
mdprc 034 04 14 000Philips HealthcareDefibrillator , HeartStart XL+NCMDR
mdprc 031 04 14 000eVent MedicalInspiration I Series VentilatorNCMDR
mdprc 001 03 14 002AbbottFreeStyle Flash and FreeStyle Blood Glucose Monitoring SystemNCMDR, MHRA, FDA
mdprc 015 04 14 000Philips HealthcareEPIQ 5 Ultrasound SystemNCMDR
mdprc 014 04 14 000Draeger Medical IncMonitor with AC2000 spring-loaded armNCMDR
mdprc 146 03 14 000Varian Medical SystemsOn-Board ImagerNCMDR
mdprc 145 03 14 000Philips Medical SystemsDigitalDiagnost X-ray System.NCMDR
mdprc 121 03 14 000GE HealthcareInnova 2100IQ, Innova 2121IQ, Innova 3100, Innova 3100IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova IGS 620, Innova IGS 630 Cardiovascular X-ray imaging systemsNCMDR
mdprc 120 03 14 000Medtronic Endovascular TherapiesFIBERNET® Embolic Protection System.NCMDR
mdprc 083 03 14 000Philips HealthcareIntelliSpace Portal with AutoSPECT Pro reconstruction applicationNCMDR
mdprc 081 03 14 000Medtronic Advanced Energy, LLCEndo‐Scrub®2 Sheaths & Tubing SetNCMDR
mdprc 080 03 14 000Baxter HealthcareHomeChoice Automated Peritoneal Dialysis Systems, HomeChoice PRO Automated Peritoneal Dialysis Systems NCMDR
mdprc 043 03 14 000Spacelabs Healthcare IncICS G2 Clinical Access CDNCMDR
mdprc 042 03 14 000MAST International LtdMast Oxidase ID D57 discsNCMDR
mdprc 041 03 14 000ArjoHuntleigh InternationalRotoprone Therapy SystemNCMDR
mdprc 133 02 14 000Medtronic IncSpinal Cord Stimulation (SCS) TherapyNCMDR
mdprc 119 02 14 000Medtronic IncActiva PC, Activa PC+S, Activa RC, Activa SC, all Restore devices (including SureScan), PrimeADVANCED, PrimeADVANCED SureScan MRI ,and Itrel 4NCMDR
mdprc 117 02 14 000AbbottARCHITECT Intact PTH assayNCMDR
mdprc 116 02 14 000pfm medical agport systems with silicone catheterNCMDR
mdprc 108 02 14 000CEREPLASCEREFORM® breast implants and sizersNCMDR
mdprc 103 02 14 000Philips HealthcareHeartStart MRx monitor/defibrillatorNCMDR
mdprc 101 02 14 000Philips HealthcareHeartStart MRx Monitor/DefibrillatorNCMDR
mdprc 100 02 14 000Philips HealthcareHeartStart MRx Defibrillator/MonitorNCMDR
mdprc 040 11 12 001Radiometer MedicalLactate membrane unitsNCMDR
mdprc 142 12 13 001GE HealthcarePET Discovery 600 and Discovery 690 Systems.NCMDR
mdprc 184 12 13 003Stryker MedicalMedical/Surgical Beds, Various S3 and Secure II Medical/Surgical Beds.NCMDR
mdprc 175 12 13 000Edwards LifesciencesFemoral Arterial and Venous Cannulae.NCMDR
mdprc 133 12 13 000MAQUET IncCompressor Mini with insufficient coolingNCMDR
mdprc 131 12 13 000GE HealthcareIGS 630 Imaging SystemsNCMDR
mdprc 130 12 13 000Covidien LtdPuritan Bennett™ 840 VentilatorNCMDR
mdprc 099 12 13 000Philips HealthcareEssenta DR X-ray SystemNCMDR
mdprc 098 12 13 000Philips HealthcareGEMINI TF 16, GEMINI TF 64, GEMINI TF Big Bore, TruFlight Select, GEMINI TF Ready and GEMINI LXL PET/CT SystemsNCMDR
mdprc 078 12 13 000Varian Medical SystemsEclipse™ Treatment Planning System, ARIA® for Radiation Oncology, ARIA® Radiation Therapy Management, and Acuity™NCMDR
mdprc 051 12 13 0003M ESPE Dental ProductsIMPRINT™ II Regular Body VPS Impression Material, PARADIGM™ Regular Body VPS Impression MaterialNCMDR
mdprc 011 12 13 000Medtronic IncCoreValve AccuTrak Delivery Catheter System (DCS)NCMDR
mdprc 010 12 13 000Abbott Vascular Devices Div Abbott Laboratories IncHT Connect Peripheral Guide WiresNCMDR
mdprc 187 11 13 000AesculapTARGON FN TELESCREWSNCMDR
mdprc 161 11 13 000Philips HealthcarePhilips HaemoSphere R4.1, Cath-labNCMDR
mdprc 145 11 13 000Draeger Medical Systems IncMedical Arm, monitor arm AC3000NCMDR
mdprc 103 11 13 001Baxter Healthcare.Cycler machine, HomeChoice 10.4NCMDR
mdprc 182 07 13 001Elekta LimitedStereotactic Circular CollimatorNCMDR
mdprc 001 11 13 000Abbott Laboratories IncAxSYM Valproic Acid, ReagentNCMDR
mdprc 150 10 13 000OlympusTHUNDERBEAT Electrosurgical Hand InstrumentsNCMDR
mdprc 135 10 13 000Hospira IncDesk Top GemStar Power Supply, Infusion pump, hospiraNCMDR
mdprc 109 09 13 000GE HealthcareImaging system software, CardiacVX and CardiacVX FlowNCMDR
mdprc 051 09 13 000Hospira IncReceptal System Liners and CanistersNCMDR
mdprc 181 08 13 000Medtronic Cardiovascular SynchroMed EL and SynchroMed II Infusion PumpsNCMDR
mdprc 167 08 13 000GE HealthcareX-ray , fluoroscopy systems, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Cardiovascular X-ray imaging systemsNCMDR
mdprc 146 08 13 000GE HealthcareMagnetic Resonance Systems, Discovery MR450, Discovery MR750, and Optima MR450wNCMDR
mdprc 126 08 13 000Philips Healthcare Air Kerma softwareNCMDR
mdprc 108 08 13 000AbbottClinical Chemistry Phosphorus Reagent.NCMDR
mdprc 183 07 13 000Baxter HealthcareVarious Irrigation Sets Used with UROMATIC and ARTHROMATIC Plastic ContainersNCMDR
mdprc 132 07 13 000Medtronic Navigation IncMedtronic Navigation StealthStation S7 and i7 Systems and Planning Station containing FrameLink Software Version 5.4NCMDR
mdprc 115 07 13 000IMPAC Medical Systems IncRadiation therapy treatment planning system, MonacoNCMDR
mdprc 087 07 13 000GE HealthcareCentricity PACS RA1000 WorkstationsNCMDR
mdprc 113 04 13 001Philips HealthcareDefibrillator, HeartStart MRx Monitor/DefibrillatorNCMDR
mdprc 072 07 13 000Medtronic DiabetesInsulin Infusion Pump, ParadigmNCMDR
mdprc 071 07 13 000Philips HealthcareMonitor/Defibrillators, HeartStart MRxNCMDR
mdprc 070 07 13 000Baxter Healthcarespray devices, Tisseel, Tisseel Lyo and Tisseel KitNCMDR
mdprc 032 07 13 000PAUL HARTMANNFolio dress gown Comfort BasicNCMDR
mdprc 119 06 13 0003M Health Care LtdDental product, Unitek™ Primary ,Stainless Steel Crowns - Series UR4NCMDR
mdprc 109 06 13 000Elekta LimitedTherapeutic Radiation System, Digital AcceleratorNCMDR
mdprc 120 02 13 001Medtronic IncLead Kits, Deep Brain Stimulation (DBS™) Lead KitsNCMDR
mdprc 089 06 13 000Medtronic Cardiovascular Revascularization & Surgical TherapyIntrathecal Catheter, SC cathetersNCMDR
mdprc 069 06 13 000MAST International LtdIdentification Disc , V FactorNCMDR
mdprc 068 06 13 000DiaMed GmbHIVDs,blood transfusion instrumentation, IH-1000NCMDR
mdprc 041 06 13 000P3 Medical LtdVentilation tube , Vented Tracheal Tube Guides (Bougies),NCMDR
mdprc 037 06 13 000ConMed Linvatec CorporationARTHROSCOPY , C7120 APEX® Arthroscopy Tubing Set, OneNCMDR
mdprc 018 06 13 000Edwards LifesciencesQuickDraw Venous CannulaeNCMDR
mdprc 017 06 13 000Varian Medical SystemsRadiotherapy Systems, High-Energy C-Series Clinac Linear AcceleratorsNCMDR
mdprc 016 06 13 000Verathon IncGlideScope Reusable AVL, GVL, and Ranger Laryngoscope BladesNCMDR
mdprc 006 06 13 000MAST International LtdIVD,CIPROFLOXACIN 1ug CARTRIDGE DISCSNCMDR
mdprc 005 06 13 000Elekta LimitedTreatment planning system , Desktop ProNCMDR
mdprc 098 05 13 000Elekta LimitedMedical software ,Radiology , XVINCMDR
mdprc 089 05 13 000Philips Medical SystemsGamma Camera , Spect CT , Gemini and Precedence Systems utilizing Brilliance CT NCMDR
mdprc 069 05 13 000DiaMed GmbHIVDs, blood transfusion instrumentation , IH-1000NCMDR
mdprc 020 05 12 001Elekta IncAll XVI R4.5 systemsNCMDR
mdprc 052 05 13 000Covidien LLC5 mm Versaport Bladeless Optical Trocars with Fixation CannulaeNCMDR
mdprc 051 05 13 000Stryker CommunicationsRouter and Control System , Switchpoint Infinity 3 (SPI3)NCMDR
mdprc 047 05 13 000Medtronic..Nerve monitoring products . NIM Flex, EMG Endotracheal TubeNCMDR
mdprc 083 04 12 001Baxter HealthcareDisposable Set Tubing, HomeChoice Disposable SetsNCMDR
mdprc 005 05 13 000Philips HealthcareDefibrillators, External, Manual, HeartStart MRx Monitor/DefibrillatorsNCMDR
mdprc 004 05 13 000Abbott Diabetes Care Div Abbott Laboratories IncAnalyzers, Point-of-Care, Whole Blood, Glucose, Precision XceedPro Blood Glucose and β-Ketone Monitoring SystemsNCMDR
mdprc 137 04 13 000Hospira IncBlood Administration Sets, Blood SetsNCMDR
mdprc 057 04 13 000Philips HealthcareScanning Systems, Computed Tomography, Brilliance CT 64, Ingenuity Core, Ingenuity Core128NCMDR
mdprc 056 04 13 000Abbott Diabetes Care Div Abbott Laboratories IncIVD, FreeStyle InsuLinx Blood Glucose MeterNCMDR
mdprc 055 04 13 000BrainLABRadiosurgery ,iPlan RT Dose systemNCMDR
mdprc 034 04 13 000Varian Medical SystemsPatient monitoring system, respiratory, radiation procedure, RPM Respiratory Gating SystemNCMDR
mdprc 033 04 13 000BrainLABStereotactic Systems, Image-Guided, Radiosurgical, Linear Accelerator, ExacTrac 5.x Patient Positioning SystemNCMDR
mdprc 032 04 13 000Hospira IncInfusion systems, GEMSTAR Infusion PumpNCMDR
mdprc 016 04 13 000Hospira IncInfusion, GemStar Infusion PumpsNCMDR
mdprc 015 04 13 000Edwards LifesciencesEdwards FloTrac SensorNCMDR
mdprc 007 04 13 000LifeScan EuropeGlucose IVD, OneTouch® Verio® pro+, Blood Glucose MeterNCMDR
mdprc 005 04 13 000Medtronic Diabetesparadigm pumpsNCMDR
mdprc 001 04 13 000Perouse MedicalFlamingo Inflation devicesNCMDR
mdprc 128 03 13 000MAQUET Cardiovascular LLCOxygenators, Extracorporeal Membrane, CARDIOHELP-i SystemsNCMDR
mdprc 054 03 13 000Siemens Medical SolutionsStationary angiographic x-ray system, digitalNCMDR
mdprc 136 02 13 000Hospira IncInfusion Pumps, Multitherapy, Various Plum A+ Infusion PumpsNCMDR
mdprc 121 02 13 000Thermo Fisher ScientificIVDs, MULTIGENT® Benzodiazepines AssayNCMDR
mdprc 119 02 13 000Medtronic IncSymplicity™ CathetersNCMDR
mdprc 118 02 13 000Baxter Corp CanadaSterile Water for irrigation for Irrigation Pour BottleNCMDR
mdprc 078 02 13 000Hospira Inclnfusion Pump, Plum A+ Family of InfusersNCMDR
mdprc 077 02 13 000Hospira IncInfusion System, Plum A+ Family of InfusersNCMDR
mdprc 114 01 13 000Philips HealthcarePhilips HeartStart XL+ Defibrillator/MonitorNCMDR
mdprc 092 01 13 000GE HealthcareInfant radiant warmers, Lullaby WarmersNCMDR
mdprc 065 01 13 000Hospira IncInfusion pump, Plum A+ Family of InfusersNCMDR
mdprc 063 01 13 000Hospira IncInfusion pump, Plum A+ Family of Infusers.NCMDR
mdprc 056 01 13 000Philips HealthcareMonitors, SureSigns Patient MonitorsNCMDR
mdprc 043 01 13 000Philips HealthcareRadiographic/Fluoroscopic Systems, Allura Xper Biplane System Allura Xper Biplane OR Table SystemNCMDR
mdprc 015 01 13 000Abbott Diagnostic International LtdReagent Controls and Calibrators, ARCHITECTNCMDR
mdprc 012 01 13 000BD Diagnostic SystemsIVD, BD MAX PCR CartridgesNCMDR
mdprc 009 01 13 000Becton Dickinson & Co. (BD)Tubes, Blood Collection, 2.7 mL Vacutainer Plus Citrate Blood Collection TubesNCMDR
mdprc 008 01 13 000BD Diagnostic SystemsIVD, BBL™ Fildes EnrichmentNCMDR
mdprc 004 01 13 000Medtronic Neuromodulationinfusion pump, SynchroMed EL implantable infusion pumpNCMDR
mdprc 164 12 12 000Philips HealthcareXray, MobileDiagnost wDRNCMDR
mdprc 163 12 12 000Philips HealthcareRadiographic Units, Mobile, MobileDiagnost wDR X-Ray Systemshttp://ncmdr.sfda.gov.sa/secure/devicerecall.aspx?cid=52C655170B
mdprc 149 12 12 000Roche IVD, COBAS® TaqMan® MTB TDF Target Elbow Max CutoffNCMDR
mdprc 148 12 12 000CovidienPipeline Embolization Device (PED)NCMDR
mdprc 147 12 12 000Philips HealthcareComputed Tomography, Brilliance CT series, iCT, iCT SP, Ingenuity Core, Ingenuity CT and MX8000 Dual v. EXPNCMDR
mdprc 146 12 12 000Maquet Cardiopulmonary AGELS Cannula - Occluded arterial lumenNCMDR
mdprc 145 12 12 000Hospira IncInfusion Pumps, Multitherapy, Various Plum A+ Infusion PumpsNCMDR
mdprc 118 12 12 000Stryker OsteosynthesisXcelerate Ceramic 4:1 Cutting Blocks.NCMDR
mdprc 117 12 12 000Philips HealthcareComputed Tomography Scanning SystemsNCMDR
mdprc 116 12 12 000Abbott Laboratories IncIVD, ARCHITECT 25-OH Vitamin DNCMDR
mdprc 052 12 12 000DiaMed AG (a Division of Bio-Rad)Data Management and Result Interpretation Software, IH-Com kit FullversionNCMDR
mdprc 051 12 12 000Bausch & Lomb IncOVD, 27G disposable cannula Amvisc and Amvisc Plus devicesNCMDR
mdprc 038 12 12 000Belmont Instrument CorpInfusion Pumps, Multitherapy, Large Volume, Belmont Rapid InfusersNCMDR
mdprc 035 12 12 000Radiometer MedicalMonitors, Bedside, Blood Gas, TCM4 series Base UnitNCMDR
mdprc 034 12 12 000Draeger Medical Systems IncPatient monitor, multiparameter, Infinity® Acute Care System (IACS) with DualHemo McableNCMDR
mdprc 131 11 12 000BitmosOximeters, Pulse, sat 805 and sat 816 Pulse Oximetry SystemsNCMDR
mdprc 092 11 12 000Radiometer MedicalBlood gas analyzer, AQT90 FLEXNCMDR
mdprc 091 11 12 000Abbott Laboratories IncIVD, Clinical Chemistry Phenobarbital reagentNCMDR
mdprc 062 11 12 000Philips HealthcarePatient Monitoring, IntelliVue Information CenterNCMDR
mdprc 041 11 12 000Verathon IncVerathon~, maker of GlideScope video laryngoscopesNCMDR
mdprc 039 11 12 000Radiometer MedicalIVD, ABL90 FLEX analyzerNCMDR
mdprc 038 11 12 000Hospira IncInfusion Pumps, Multitherapy, Plum A+ Single-Channel Infusion PumpsNCMDR
mdprc 022 11 12 000Philips HealthcareComputed Tomography, TumorLOC in Brilliance CT Big Bore, Extended Brilliance Workspace (EBW), GEMINI LXL, GEMINI TF 16, GEMINI TF 64, GEMINI TF Big BoreNCMDR
mdprc 021 11 12 000Philips HealthcareDigitalDiagnost X-ray System.NCMDR
mdprc 020 11 12 000Philips HealthcareDigitalDiagnost X-ray SystemNCMDR
mdprc 019 11 12 000Philips HealthcareMonitoring Systems, PhysiologicNCMDR
mdprc 041 10 12 000Synthes IncSurgical instruments, Cancellous Bone Impactor Ø 6.0 mm, round, flattenedNCMDR
mdprc 035 10 12 000BD Diagnostic SystemsBD Oral Dispensing SyringeNCMDR
mdprc 034 10 12 000BD Diagnostic SystemsCatheter tip occuluder, BD Venflon ObturatorNCMDR
mdprc 015 10 12 000Philips HealthcareComputed tomography system, Extended Brilliance Workstation (EBW)NCMDR
mdprc 014 10 12 000Radiometer MedicalAnalyzers, AQT90 FLEXNCMDR
mdprc 013 10 12 000Elekta IncRadiotherapy software, MOSAIQNCMDR
mdprc 187 09 12 000Invacare Corporation Patient Transfer Aids, Birdie and Flamingo Mobile Patient Hoists CarabinersNCMDR
mdprc 186 09 12 000Abbott Laboratories IncReagent, ARCHITECT HAVAb-IgGNCMDR
mdprc 160 09 12 000Radiometer MedicalIVD, analyzer ABL90 FLEXNCMDR
mdprc 159 09 12 000Radiometer Medicalanalyzers, AQT90 FLEXNCMDR
mdprc 157 09 12 000Radiometer MedicalBlood gas analyzer,, ABL80 FLEX analyzerNCMDR
mdprc 147 09 12 000Philips Medical SystemsX ray, digital acquisition systems direct digital radiography, DigitalDiagnostNCMDR
mdprc 146 09 12 000Maquet Cardiopulmonary AGCannulae, HLS CannulaeNCMDR
mdprc 138 09 12 000Draeger Medical Incmedical air, Compressed Air System and dryerNCMDR
mdprc 137 09 12 000Philips HealthcareAutomatic Patient Linking, iSite PACS 4.1.xNCMDR
mdprc 136 09 12 000Philips HealthcareHeartStart XL Defibrillator/Monitor BatteryNCMDR
mdprc 049 09 12 000Hospira IncMedicine Bottles, Empty Evacuated ContainersNCMDR
mdprc 048 09 12 000Philips Healthcarecomputed tomography, Brilliance CT Big BoreNCMDR
mdprc 075 12 11 001Elekta IncRadiology, X-ray, Digital AcceleratorNCMDR
mdprc 020 09 12 000Radiometer MedicalIVD, AQT90 FLEX analyserNCMDR
mdprc 019 09 12 000Radiometer MedicalIVD, ABL800 and ABL700 with XPE analyzersNCMDR
mdprc 018 09 12 000Radiometer MedicalIVD, ABL80 BASIC analyzerNCMDR
mdprc 017 09 12 000Varian Medical SystemsEclipse™ Treatment Planning SystemNCMDR
mdprc 016 09 12 000Radiometer America IncIVD, ABL80 CO-OX analyzerNCMDR
mdprc 015 09 12 000Philips HealthcareBrilliance CT 16 SliceNCMDR
mdprc 014 09 12 000Philips HealthcareMonitoring Systems, Physiologic, SureSigns Patient MonitorsNCMDR
mdprc 013 09 12 000Philips HealthcareCT, MX 16-SliceNCMDR
mdprc 012 09 12 000Abbott Vascular Devices Div Abbott Laboratories IncCatheter, Armada 35 and Armada 35 LL Percutaneous Transluminal Angioplasty (PTA) CatheterNCMDR
mdprc 076 08 12 000Varian Medical SystemsAccelerator System, Linear, Clinac, Trilogy,NCMDR
mdprc 075 08 12 000Philips HealthcareComputed Tomography, Brilliance CT 6, 16, MX8000 v. EXP and GEMINI DualNCMDR
mdprc 034 08 12 0003M Health Care LtdDrape™ Surgical Drape Packs, Pediatric cvc DrapeNCMDR
mdprc 033 08 12 000GE HealthcareCardiovascular X-ray imaging systems, Innova 2121IQ, Innova 3131IQNCMDR
mdprc 022 08 12 000Elekta IncBeam shaping solution, The Agility™ beam limiting device (BLD), Apex™NCMDR
mdprc 001 08 12 000Abbott Laboratories IncIVD, ARCHITECT Toxo IgG reagentNCMDR
mdprc 112 07 12 000CovidienShiley Reusable Cannula Low-Pressure Cuffed Tracheostomy TubesNCMDR
mdprc 089 07 12 000Baxter HealthcareIntravenous Solution Compounders, Various AUTOMIX Automated Nutrition CompoundersNCMDR
mdprc 088 07 12 000SIEMENSPicture archiving and communication system, radiology, Syngo. Plaza and Syngo Imaging XSNCMDR
mdprc 087 07 12 000Advanced Sterilization ProductsSTERRAD CycleSure 24 Biological IndicatorNCMDR
mdprc 035 07 12 000Stryker InstrumentsInstrument Trays, Arthroscope and Hardware Set TraysNCMDR
mdprc 020 07 12 000Philips HealthcareComputed tomography, Brilliance series 6, 16, 40, 64, CT Big Bore, iCT, and iCT SPNCMDR
mdprc 019 07 12 000Varian Medical SystemsRadiation Therapy, Eclipse Treatment Planning SystemNCMDR
mdprc 005 07 12 000Philips HealthcareDefibrillators, HeartStart MRx Monitor/DefibrillatorsNCMDR
mdprc 158 06 12 000Stryker MedicalScales, Patient, Bed Scales and Chaperone Bed Exit Systems NCMDR
mdprc 157 06 12 000Philips HealthcareDefibrillators, External, HeartStart MRx Monitor/DefibrillatorsNCMDR
mdprc 156 06 12 000Philips Healthcare Information Systems, Xcelera Connect R2.1L1 SP2NCMDR
mdprc 155 06 12 000DiaMed GmbHBlood bank Analyzer, Techno TwinStationNCMDR
mdprc 135 06 12 000Varian Medical Systems Rectal retractor, titanium, white acetal, ontained in Ring and Tandem Combination Applicator Sets NCMDR
mdprc 127 06 12 000BrainLABPlanning software, iPlan RT Dose version 4.1NCMDR
mdprc 094 06 12 000Sekisui DiagnosticsIVD, MULTIGENT Acetaminophen ReagentNCMDR
mdprc 093 06 12 000Draeger Medical IncPhototherapy unit, PT 4000 for neonateslinfantsNCMDR
mdprc 067 06 12 000Stryker Howmedica Osteonics CorpNeptune Rover Waste Management SystemsNCMDR
mdprc 062 06 12 000Philips HealthcareX-Ray System, MultiDiagnost ElevaNCMDR
mdprc 061 06 12 000GE HealthcareMonitor, CARESCAPETM Monitor B650NCMDR
mdprc 060 06 12 000GE HealthcareMRI, Signa and DiscoveryNCMDR
mdprc 059 06 12 000GE HealthcareMonitor, CARESCAPE TM Monitor B850NCMDR
mdprc 055 06 12 000Integra LifeSciences ORTHOPAEDICDrilling guide for diameter 3.5 mm screwNCMDR
mdprc 018 06 12 000Natus Medical IncOlympic Cool-Cap systemNCMDR
mdprc 017 06 12 000Abbott Laboratories IncReagent Kit, ARCHITECT CA 19-9XRNCMDR
mdprc 016 06 12 000Varian Medical SystemsAccelerator System, TrueBeamNCMDR
mdprc 008 06 12 000Covidien Ltd.Surgical Stapler, ROTICULATOR™ Single Use StaplerNCMDR
mdprc 077 05 12 000Philips Medical SystemsAll DigitalDiagnost (with release 2.0.2 and 2.0.2SP1NCMDR
mdprc 040 05 12 000Philips HealthcareComputed Tomography, Brilliance iCT and iCT SPNCMDR
mdprc 039 05 12 000PAUL HARTMANNSterile gauze productsNCMDR
mdprc 038 05 12 000DePuy International LimitedDePuy DeltaMotion® Acetabular CupNCMDR
mdprc 021 05 12 000Philips Medical SystemsPractix Convenio Mobile X-ray SystemNCMDR
mdprc 016 05 12 000Advanced Sterilization ProductsCleaning, GLOSAIR™ 400 CartridgesNCMDR
mdprc 001 05 12 000ThermoFisher ScientificReagent, MULTIGENT Hemoglobin A1c ReagentNCMDR
mdprc 112 04 12 000DiaMed AG (a Division of Bio-Rad)IVDs, blood transfusion instrumentation, IH-Com software Full kit versionNCMDR
mdprc 085 04 12 000Elekta IncRadiology, X-ray, MLCi and MLCi2 radiation headsNCMDR
mdprc 082 04 12 000Draeger Medical Systems IncGas supply System, G40600NCMDR
mdprc 058 04 12 000Abbott Laboratories IncReagents, ARCHITECT STAT Troponin-INCMDR
mdprc 057 04 12 000GE HealthcareWorkstation software, READY ViewNCMDR
mdprc 052 04 12 000Philips HealthcareMonitor/defibrillator, Philips HeartStart MRxNCMDR
mdprc 020 04 12 000Philips Medical SystemsRadiographic system, DigitalDiagnostNCMDR
mdprc 002 04 12 000St. Jude Medical Inc.Implants, active, stimulators, neuro, BRIO IPG (MODEL 6788)NCMDR
mdprc 001 04 12 000Philips HealthcareRadiographic/Fluoroscopic SystemsNCMDR
mdprc 113 03 12 000Philips HealthcareComputed Tomography, Brilliance 6, Brilliance 16, Brilliance 40, Brilliance 64, Brilliance CT Big Bore, iCT, iCT SP and Ingenuity CTNCMDR
mdprc 104 03 12 000GE Medical SystemsOptima MR450W with GEM option, MRINCMDR
mdprc 102 03 12 000Human GmbhRapid Immunochromatographic test, a.m. lots of HEXAGON HIVNCMDR
mdprc 080 03 12 000MedtronicInfusion pump, SynchroMed® II PumpNCMDR
mdprc 079 03 12 000BrainLABAll Brainlab BrainSCAN and iPlan RT treatment planning software versionsNCMDR
mdprc 011 03 12 000Integra LifeSciencesAdvansys Medial Lisfranc PlatesNCMDR
mdprc 001 03 12 000GE HealthcareGamma camera, stationary. Infinia Nuclear Medicine systems,NCMDR
mdprc 187 02 12 000GE HealthcareX-ray system, diagnostic. Series 7600/7700 Mobile C-Arm,, Interconnect PO CableNCMDR
mdprc 186 02 12 000BaxterHemofiltration Units , Aquarius RCA Hemofiltration SystemsNCMDR
mdprc 168 02 12 000CovidienTubing and Syringes, Disposable Imaging Device Accessories;NCMDR
mdprc 167 02 12 000AbbottIVD, AxSYM Free T4 Standard Calibrators and ControlsNCMDR
mdprc 121 02 12 000Varian Medical SystemsVarian Clinac® accelerators with Mark or Millennium MLC and BrainLAB m3 MLCNCMDR
mdprc 120 02 12 000Philips HealthcareComputed Tomography, Brilliance Workspace PortalNCMDR
mdprc 085 02 12 000Philips HealthcareIntelliVue Patient MonitorsNCMDR
mdprc 054 02 12 000Accuray IncRadiology, Treatment, MultiPlan® Treatment Planning SystemNCMDR
mdprc 108 01 12 000Stryker OrthopaedicsImplants, Knee. Scorpio Tibial Punch TowerNCMDR
mdprc 107 01 12 000Philips HealthcareComputed Tomography, Software. TurnorLOC in Brilliance CT Big Bore and GEMlNlNCMDR
mdprc 094 01 12 000Varian Medical SystemsRadiotherapy Systems, Linear Accelerator, C-Series Clinac and Trilogy Linear AcceleratorsNCMDR
mdprc 093 01 12 000Elekta IncXVI R4.5 and R4.6 without iGuide®NCMDR
mdprc 075 01 12 000Philips HealthcareMultiDiagnost Eleva FDNCMDR
mdprc 074 01 12 000GE HealthcareLOGIQ E9 Diagnostic Ultrasound SystemsNCMDR
mdprc 001 01 12 000AbbottIVD, Reagents, QUANTIA FERRITIN / MYOGLOBIN / IGE CONTROLNCMDR
mdprc 097 12 11 000GE HealthcareX-Ray System, diagnostic. OEC FluorostarMHRA
mdprc 090 12 11 000MTP Medical Technical Promotion GMBHSingle-Use Gas FiltersNCMDR
mdprc 089 12 11 000Medtronic IncCannulae, DLP® Single Stage Venous CannulaeNCMDR
mdprc 088 12 11 000GE HealthcareRadiographic Systems, Definium 8000 and Discovery XR650 Patient BarrierNCMDR
mdprc 049 12 11 000GE HealthcareWorkstations, Radiotherapy, Planning. Advantage Workstation ServersNCMDR
mdprc 048 12 11 000Varian Medical SystemsRadiation Therapy, Treatment Planning System. 4D Structure Merge Tool Option in EclipseNCMDR
mdprc 047 12 11 000Philips HealthcareScanning Systems, Computed Tomography, BrillianceNCMDR
mdprc 003 12 11 000GE Healthcare X-Ray Diffraction SystemsNCMDR
mdprc 094 11 11 000Philips HealthcareUniversal X-ray system, DiagnostNCMDR
mdprc 093 11 11 000Philips HealthcareRadiographic Units, Mammography, MammoDiagnost DRNCMDR
mdprc 092 11 11 000INTEGRASurgical, Compression guide, TIBIAXYSNCMDR
mdprc 091 11 11 000Varian Medical SystemsRadiation Therapy, Eclipse with ARIA™ Radiation Oncology (RT Chart module)NCMDR
mdprc 090 11 11 000AbbottReagents, Tobramycin CalibratorsNCMDR
mdprc 051 11 11 000StrykerSolis Trial CageNCMDR
mdprc 050 11 11 000BrainLABBrainSCAN ,Pencil Beam Dose AlgorithmNCMDR
mdprc 028 11 11 000Professional Disposables International (PDI)Single-use, Antiseptic, Nonsterile Alcohol Prep PadsNCMDR
mdprc 027 11 11 000GE HealthcareElectrocardiography, CARESCAPE MonitorNCMDR
mdprc 095 10 11 000Thomas Medical Products-Through BiotronikVarious SafeSheath and Situs ProductsNCMDR
mdprc 094 10 11 000StrykerInferior Border Osteotomy (IBO) bladesNCMDR
mdprc 093 10 11 000GE HealthcareGE CentricityTM Critical Care, Information System, Patient recordNCMDR
mdprc 092 10 11 000GE HealthcareDiagnostic, general-purpose, MobileX-ray systemNCMDR
mdprc 066 10 11 000Draeger Medical IncVentricular Fibrillation ,Patient MonitorNCMDR
mdprc 060 10 11 000Elekta IncLinear Accelerator, Dual RegistrationNCMDR
mdprc 059 10 11 000Accuray IncSyunchrony, Camera array mounting assemblyNCMDR
mdprc 046 10 11 000Draeger Medical Systems IncMonitoring, Infinity® Acute Care System (IACS)NCMDR
mdprc 045 10 11 000Abbott Medical Optics Inc.Optical, surgical, Femto second Laser SystemsNCMDR
mdprc 017 10 11 000Abbott Laboratories IncLaboratory, Architect, Cyclosporine assayNCMDR
mdprc 016 10 11 000Abbott DiagnosticReagent Pack, AxSYM AUSABNCMDR
mdprc 015 10 11 000Varian Medical SystemsAccelerator System, Linear, True BeamNCMDR
mdprc 014 10 11 000Philips HealthcareMobile X-ray units Endura, Pulsera and VeradiusNCMDR
mdprc 013 10 11 000Hospira IncInfusion Pumps, Plum A+,Plum A+ Hyperbaric single Channels, Plum A+3 Triple ChannelNCMDR
mdprc 012 10 11 000AbbottReagent, Clinical Chemistry Urea NitrogenNCMDR
mdprc 071 09 11 000Stryker CommunicationsSwitchPoint Infinity, Equipment Booms ,Surgical LightsNCMDR
mdprc 070 09 11 000Abbott Medical Optics Inc.Optics, Intraocular Lenses (IOLs), Sensar®NCMDR
mdprc 056 09 11 000Philips HealthcareInformation Systems, ICIP D & E UpdateNCMDR
mdprc 055 09 11 000bioMerieux IncIVD, Rapid testingNCMDR
mdprc 030 09 11 000bioMerieux IncSlidex Staph plusNCMDR
mdprc 023 09 11 000Varian Medical SystemsEclipse Treatment Planning SystemNCMDR
mdprc 022 09 11 000Abbott Diagnostic International LtdReagents, Clinical Chemistry Alkaline PhosphataseNCMDR
mdprc 067 08 11 000GS Elektromedizinische Geraete G Stemple GmbHCorpuls DefibrillatorNCMDR
mdprc 066 08 11 000Varian Medical Systems4D Integrated Treatment ConsoleNCMDR
mdprc 065 08 11 000Varian Medical SystemsEclipse treatment planning systemNCMDR
mdprc 046 08 11 000GE HealthcareCardiovascular X-ray imaging systemsNCMDR
mdprc 029 08 11 000BrainLABBrainlab SkullNCMDR
mdprc 012 08 11 000GE HealthcareVarious Magnetic Resonance SystemsNCMDR
mdprc 001 08 11 000Stryker Howmedica Osteonics CorpProthesis, Distal Femur and Femoral JointNCMDR
mdprc 105 07 11 000Varian Medical SystemsEclipse Treatment Planning SystemNCMDR
mdprc 086 07 11 000Medtronic IncFlexCath Steerable SheathsNCMDR
mdprc 077 07 11 000Abbott Medical OpticsExcimer Laser SystemNCMDR
mdprc 069 07 11 000Abbott Diagnostic International LtdARCHITECT C-Peptide ReagentNCMDR
mdprc 068 07 11 000TomoTherapy IncorporatedHi-Art DICOM SystemNCMDR
mdprc 028 07 11 000Varian Medical SystemsTreatment planning system, EclipseNCMDR
mdprc 027 07 11 000Philips HealthcareIntelliVue Clinical Information PortfolioNCMDR
mdprc 026 07 11 000Philips HealthcareImaging, Allura XperNCMDR
mdprc 025 07 11 000SIEMENSX-Ray AngiographyNCMDR
mdprc 014 07 11 000BD Diagnostic SystemsBD Vacutainer Plus Citrate blood collection tubesNCMDR
mdprc 003 07 11 000Ohio Medical CorporationAC Powered Portable AspiratorNCMDR
mdprc 002 07 11 000Intuitive Surgical Incda Vinci Intuitive Surgical SystemNCMDR
mdprc 111 06 11 000Ortho-Clinical DiagnosticsVITROS Chemistry ProductsNCMDR
mdprc 085 06 11 000GE HealthcareMagnetic Resonance Imaging, Optima and Brivo.NCMDR
mdprc 081 06 11 000Hitachi Medical CorpHitachi MR Imaging SystemNCMDR
mdprc 032 06 11 000BrainLABBrainlab Cranial/ENT Navigation SoftwareNCMDR
mdprc 029 06 11 000Philips HealthcareSureSigns Patient Monitors and Vital Signs MonitorsNCMDR
mdprc 020 06 11 000Codman Johnson & JohnsonCodman Disposable Drill Kit ProductsNCMDR
mdprc 004 06 11 000TcoagMinutex D-Dimer, ReagentsNCMDR
mdprc 003 06 11 000GE HealthcarePositron Emission Tomography SystemNCMDR
mdprc 002 06 11 000bioMerieux IncSlidex Staph Kits, ReagentsNCMDR
mdprc 113 05 11 000Smith & Nephew incREMOVE Universal Adhesive Remover WipesNCMDR
mdprc 112 05 11 000Philips HealthcareBrilliance 64 Computed Tomography SystemNCMDR
mdprc 081 05 11 000St. Jude Medical IncImplantable Pulse GeneratorsNCMDR
mdprc 080 05 11 000Spacelabs Healthcare IncSpacelabs Medical Capnography ModuleNCMDR
mdprc 079 05 11 000BIOTRONIK UK LtdPasseo peripheral balloon catheterNCMDR
mdprc 078 05 11 000GE HealthcareThoracic VCAR application software on Advantage WorkstationNCMDR
mdprc 053 05 11 000Draeger Medical Systems IncGas Management SystemsNCMDR
mdprc 052 05 11 000Draeger Medical Systems IncIncubators, Perinatal CareNCMDR
mdprc 017 05 11 000Philips HealthcareMagnetic Resonance ImagingNCMDR
mdprc 012 05 11 000GE HealthcareMagnetic Resonance SystemsNCMDR
mdprc 011 05 11 000GE HealthcareMRI SystemsNCMDR
mdprc 033 04 11 000Medtronic IncSprint Fidelis® Lead, DefibrillatorNCMDR
mdprc 032 04 11 000MedtronicDual Chamber PacemarkerNCMDR
mdprc 031 04 11 000Varian Medical SystemsClinac Linear acceleratorNCMDR
mdprc 030 04 11 000Triad GroupCon-Zellin Alcohol SwabsNCMDR
mdprc 123 03 11 000GE HealthcareBrightSpeed Computed Tomography X-ray systemNCMDR
mdprc 122 03 11 000GE HealthcareLightSpeed Computed Tomography X-ray SystemNCMDR
mdprc 104 03 11 000Baxter Corp CanadaCOLLEAGUE Infusion PumpsNCMDR
mdprc 086 03 11 000Ziehm Imaging GmbHVarious Mobile X-Ray SystemsNCMDR
mdprc 085 03 11 000Abbott Diagnostic International LtdShear Valve AssemblyNCMDR
mdprc 084 03 11 000BD Diagnostic SystemsBD Microtrol - Candida albicans, IVDNCMDR
mdprc 083 03 11 000Philips HealthcareIntelliVue Clinical Information Portfolio ICIPNCMDR
mdprc 082 03 11 000Philips HealthcareMX 16-slice CT scannersNCMDR
mdprc 068 03 11 000Lifescan Johnson & JohnsonBlood Glucose MonitorNCMDR
mdprc 046 03 11 000MedtronicLucas Chest Compression SystemsNCMDR
mdprc 029 03 11 000GE HealthcareAdvantage Workstation Reporting Tool, X-ray systemNCMDR
mdprc 028 03 11 000Abbott Diagnostic International LtdARCHITECT Clinical Chemistry AnalyserNCMDR
mdprc 027 03 11 000AbbottCELL-DYN Emerald CleanerNCMDR
mdprc 013 03 11 000Philips HealthcarePhilips iSite PACs productNCMDR
mdprc 009 03 11 000GE HealthcareTruSat Pulse OximeterNCMDR
mdprc 008 03 11 000Trumpf Medical Systems, Inc.Operating table TITANNCMDR
mdprc 061 02 11 000Hospira IncPlum A+ Infusion PumpsNCMDR
mdprc 049 02 11 000Varian Medical SystemsRT Chart, ARIA Information SystemNCMDR
mdprc 042 02 11 000Becton Dickinson & Co. (BD)BD Microlance 30G x NeedleNCMDR
mdprc 041 02 11 000Abbott LaboratoriesARCHITECT 25-OH Vitamin D ReagentNCMDR
mdprc 024 02 11 000Philips HealthcareHeartStart MRx monitor/defibrillatorsNCMDR
mdprc 009 02 11 000GE HealthcareBrightSpeed Excel/Edge/Elite Select and BrightSpeed Elite Computed Tomography X-ray SystemNCMDR
mdprc 008 02 11 000Nihon Kohden CorpKC 600P Cart, beside MonitorNCMDR
mdprc 086 01 11 000Baxter Healthcare3-Way Large Bore StopcocksNCMDR
mdprc 085 01 11 000Varian Medical SystemsClinac 2100, Linear Accelerator SystemNCMDR
mdprc 084 01 11 000AbbottARCHITECT iVancomycin ReagentNCMDR
mdprc 083 01 11 000Philips HealthcareAllure FD10, FD20 and CV20, Xray systemNCMDR
mdprc 080 01 11 000Philips HealthcareFixing Strap of the Laser Aiming Device Image Intensifier, Mobile X-RayNCMDR
mdprc 043 01 11 000Philips HealthcareBrilliance, Computed TomographyNCMDR
mdprc 018 01 11 000Edwards LifesciencesAscendra 2 Delivery SystemNCMDR
mdprc 012 01 11 000Varian Medical SystemsRadiotherapy, 4D Integrated Treatment ConsoleNCMDR, MHRA
mdprc 011 01 11 000Ethicon Inc A Johnson & Johnson CoETHILON SUTURESNCMDR
mdprc 010 01 11 000Integra LifesciencesLicox Tissue Oxygen MonitorsNCMDR
mdprc 007 01 11 000Philips HealthcarePrecedence and SKYLight SPECT SystemsNCMDR
mdprc 003 01 11 000Varian Medical SystemsHigh Energy C Series Clinac, AcceleratorNCMDR