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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
BfArM
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Reference NumberManufacturerDevice TypeReport Source
mdprc 022 03 22 001SIEMENSARTIS Q, ARTIS Q.Zen, ARTIS Q Zeego, ARTIS Zeego, ARTIS ZEENCMDR
mdprc 018 05 23 001Illumina IncNextSeq 550 Dx and MiSeq Dx instrumentsBfArM
mdprc 012 12 23 000Karl Storz Endoscopy UK LtdMultiple products by Karl Storz BfArM
mdprc 042 08 23 000HAMILTON MEDICAL AGHamilton Medical Ventilators HAMILTON-C1/T1/C2/C3 with Neonatal OptionBfArM
mdprc 024 08 23 000ArthrexKNEE SCORPIONBfArM
mdprc 021 08 23 000Diatron MI PlcDiacon 3 hematology control ( (Low) 6x, (Normal), (High) 6 )BfArM
mdprc 020 08 23 000Ethicon, Inc.PDS TM II (polydioxanone) Suture, PDS TM Plus Antibacterial (polydioxanone) SutureBfArM
mdprc 014 08 23 000W.L. Gore & Associates Inc.Gore tips setBfArM
mdprc 012 08 23 000Drager Medical Systems IncFilter/HME TwinStar® PlusBfArM
mdprc 025 07 23 000Omixon Biocomputing Ltd.Omixon HLA Twin BfArM
mdprc 022 07 23 000CellaVision-RAL DiagnosticsBuffer solution for SP automated systemsBfArM
mdprc 014 06 23 001EKU Elektronik GmbH.NO-Therapy device NO-A (in combination with ventilators Servo-n and Servo-u)BfArM, NCMDR
mdprc 018 06 23 000Draeger Medical Systems IncOxylog 3000 plusBfArM
mdprc 015 06 23 001NOxBOX Ltd.NOxBOXi Nitric Oxide Delivery DeviceBfArM, NCMDR
mdprc 013 06 23 000EKU Elektronik GmbH.NO-Therapy device NO-A (in combination with ventilator Leoni Plus) BfArM
mdprc 008 06 23 000UFSK-International OSYS GmbhTreatment chairs 500 XLEBfArM
mdprc 019 05 23 000Huntleigh HealthcareTeam3 Fetal MonitorBfArM
mdprc 011 05 23 000PTW-Freiburg Physikalisch-Technische Werkstatten Dr. Pychlau GmbHPTW ArrayCal - module of BeamAdjustBfArM
mdprc 016 04 23 000Draeger Medical Systems IncSeattle PAP plus, Neo disposable breathing systems, Coax ventilation hoses, Pediatric disposable breathing systems, Set2Go & Pack2GoBfArM
mdprc 014 04 23 000Instrumentation Laboratory SpA, a Werfen CompanyACL ELITE/ELITE PRO HEMOSTASIS TESTING SYSTEMSBfArM
mdprc 013 04 23 000Reproline medical GmbHSOFT DENUDATION TIPS AND FOLLICLE PUNCTION SYSTEMSBfArM
mdprc 012 04 23 000Samsung ElectronicsDigital Diagnostic Mobile X-ray System GM85BfArM
mdprc 024 03 23 000Draeger Medical Systems IncInfinity CentralStation, Infinity M300/M300+BfArM
mdprc 023 03 23 000ColoplastTitan Inflatable Penile ProsthesisBfArM
mdprc 007 02 23 000Tracoe medical GmbHTRACOE experc Set twist, twist plus, varioBfArM
mdprc 001 02 23 000Schiller AGAT-102 / AT-102 plus / AT-10 plus /AT-104 PC / AT-104 PC ErgoSpiro MS-2007 / MS-2010 / MS-2015 / CS-200 / CS-200 ErgoSpiroBfArM
mdprc 014 01 23 000Draeger Medical Systems IncNovaStar plus and Nova Star TSBfArM
mdprc 013 01 23 000WeinmannMEDUMAT Standard²BfArM
mdprc 009 01 23 000FUJIFILM Medical SystemsDR-XD 1000(FDR Nano) BfArM
mdprc 041 12 22 000Draeger Medical Systems IncZeus, Zeus IE, and Zeus Kit C500 Anesthesia Workstations with DIVA Sevoflurane ModulesBfArM
mdprc 038 12 22 000Leica Biosystems Newcastle LtdNovocastra Liquid Mouse Monoclonal Antibody Muscle Specific ActinBfArM
mdprc 032 12 22 000Cooper Surgical Inc.NEO-fit Neonatal Endotracheal Tube GripBfArM
mdprc 022 12 22 000Ivoclar Vivadent AG..VivaPen Snap-On Cannula and Adhese Universal in the VivapenBfArM
mdprc 021 12 22 000ENDO-FLEX GmbHBiopsy Forceps SUBfArM
mdprc 014 12 22 000HUMAN Gesellschaft für Biochemica und Diagnostica GmbHHumaTex RF complete kit & RF Latex ReagentBfArM
mdprc 011 12 22 000Siemens Healthcare Diagnostics GmbHAtellica IM Free Prostate-Specific Antigen (fPSA)BfArM
mdprc 035 11 22 000Lohmann & RauscherVliwaktiv Absorbent activated charcoal dressingBfArM
mdprc 034 11 22 000Draeger Medical Systems IncPolaris MultimediaBfArM
mdprc 022 11 22 000Roche Diagnostics GmbHVENTANA PD-L1BfArM
mdprc 002 11 22 001Regen Lab SAA-CP Kits Family, RegenKit-BCT FamilyBfArM
mdprc 012 11 22 000Siemens Healthcare Diagnostics ProductIMMULITE and IMMULITE 1000BfArM
mdprc 001 11 22 000Huntleigh HealthcareSonicaid FreedomBfArM
mdprc 018 10 22 000Siemens Healthcare Diagnostics IncAtellica CH 930 AnalyzerBfArM
mdprc 015 10 22 000Nutricia Medical DevicesNutricia Flocare Infinity II enteral feeding pumpBfArM
mdprc 020 09 22 000Lowenstein Medical GmbH &Co.KGelisa 600/800/800VIT ventilatorBfArM
mdprc 014 06 22 001Lohmann & RauscherGauze compresses with x-ray threadBfArM, NCMDR
mdprc 011 08 22 000FUJIFILM Healthcare CorporationSCENARIA View / Supria / SpeediaBfArM
mdprc 010 08 22 000Waldemar LINK GmbH & CoEndo-Model-M and Endo-Model SL (Tibial Components)BfArM
mdprc 009 08 22 000Siemens Healthcare Diagnostics ProductIMMULITE 2000, IMMULITE 2000 XpiBfArM
mdprc 025 07 22 000Schiller AGDEFIGARD Touch7BfArM
mdprc 036 06 22 000AbbottMerlin Patient Care System (PCS) and Merlin.net MN 5000 Remote Monitoring ApplicationBfArM
mdprc 028 06 22 000SIEMENSSensis, Sensis Vibe ComboBfArM
mdprc 022 06 22 000Bohus BioTech ABMicrovisc 1%,Microvisc Plus 1,4%,Microvisc Phaco 2,5%BfArM
mdprc 019 06 22 000Instrumentation Laboratory SpA, a Werfen CompanyILab Taurus analyzers with software versions 1.20p (and up) and firmware version 2.06 (and up)BfArM
mdprc 030 05 22 000Siemens Healthcare Diagnostics GmbHAtellica IM 1300/1600 Analyzer T3 AssayBfArM
mdprc 025 05 22 000Ortho-Clinical DiagnosticsORTHO VISION and ORTHO VISION Max AnalyzersBfArM
mdprc 024 05 22 000Siemens Healthcare Diagnostics ProductADVIA 2120/2120i Hematology Systems. BfArM
mdprc 018 05 22 000UROMED Kurt Drews KGUROMED-Einmal-Nelaton/Tiemann-KatheterBfArM
mdprc 017 05 22 000WEINMANN Emergency Medical Technology GmbH + Co.KG Li-Ion battery for ACCUVAC ProBfArM
mdprc 010 04 22 000Draeger Medical Systems IncInfinity CentralStationBfArM
mdprc 006 04 22 000Dentsply Sirona, IncTeneo Treatment CentersBfArM
mdprc 005 04 22 000Osatu S.Coop.Electrodes for Defibrillation "Bexen Cardio"BfArM
mdprc 004 04 22 000Schiller AGFRED easyport plus defibrillatorBfArM
mdprc 045 03 22 000Hill Rom IncCompella Bariatric Bed Systems and Therapy Air Supply UnitsBfArM
mdprc 044 03 22 000Safe OrthopaedicsOriginal and Essential Kit Pedicle Screw systemsBfArM
mdprc 037 03 22 000Lowenstein Medical GmbH &Co.KGTrolley for the "elisa" seriesBfArM
mdprc 030 03 22 000SIEMENSARTIS icono and ARTIS pheno systems.BfArM
mdprc 015 03 22 000ADVANCED MEDICAL SOLUTIONS LTDLiquiBand FIX8 Open Hernia Mesh Fixation DeviceBfArM
mdprc 001 03 22 000Draeger Medical Systems IncInfinity Acute Care SystemBfArM
mdprc 026 02 22 000Thermo Fisher Scientific OyThermo Scientific QMS Tacrolimus CalibratorBfArM
mdprc 024 02 22 000Welch Allyn, Inc.Q-Stress®, XScribe™, HScribe™, Vision Express™, RScribe™ systems, Diagnostic Cardiology Suite™(DCS), Connex® Cardio ECGBfArM
mdprc 018 02 22 000SIEMENSACUSON Juniper ultrasound system with Juniper 1.0 (VA10D / VA10E / VA10F) softwareBfArM
mdprc 012 02 22 000MicroVention EuropeHydroSoft 3D Endovascular Embolization CoilBfArM
mdprc 016 12 21 001Natus NeurologyIPELA FHD PTZ TILE KITSBfArM
mdprc 020 01 22 000VOLCANO CORPORATIONSyncVision SystemsBfArM
mdprc 008 01 22 000Jafron Biomedical Co.,LtdDisposable Hemoperfusion Cartridge (HA)BfArM
mdprc 005 01 22 000MAQUET Cardiopulmonary GmbHTubing setsBfArM
mdprc 018 12 21 000Accelerate Diagnostics IncAccelerate Pheno system..BfArM
mdprc 017 12 21 000Hain Lifescience GmbH.GenoType MTBDRplus Ver 2.0 / GenoType MTBDRsl 2.0/2,0BfArM
mdprc 012 12 21 000Leica Biosystems NewcastleBOND Epitope Retrieval Solution 1 & 2, BOND Wash Solution 1OX ConcentrateBfArM
mdprc 009 12 21 000MEDE TechnikK-WIRES 15cm ⌀1,4mm TR/RDBfArM
mdprc 035 11 21 000SPINEART SAPolyaxial Perla Screw Ø3.5BfArM
mdprc 016 02 21 002Nuvasive Specialized Orthopaedics Inc.All Precice System DevicesBfArM, NCMDR
mdprc 033 10 21 000Lumenis IncEcoGel 200BfArM
mdprc 030 10 21 000Balt ExtrusionIVA sterile packagingBfArM
mdprc 013 10 21 000SIEMENSSensis, Sensis Vibe Combo, Sensis Vibe Hemo.BfArM
mdprc 002 10 21 000Arrow International IncArrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic DeviceBfArM
mdprc 028 09 21 000Thermo Fisher Scientific OyRheumatoid Factors 2 (RF 2)BfArM
mdprc 017 09 21 000Welch Allyn, IncELI280, MLBUR280 and BUR280 ElectrocardiographsBfArM
mdprc 015 09 21 000SIEMENSsyngo.via RT Image SuiteBfArM
mdprc 008 09 21 000Draeger Medical Systems IncAtlan A300, Atlan A300XL, Atlan A350, Atlan A350XLBfArM
mdprc 035 08 21 000CooperSurgical, Inc…OXYGEN SENSORSBfArM
mdprc 031 08 21 000Boule Medical ABMedonic M-Series/M32 Autoloader with Automatic Barcode Reader; Swelab Alfa/ Alfa Plus Sampler instruments with Automatic Barcode ReaderBfArM
mdprc 004 08 21 000W.L. Gore & Associates Inc.GORE PROPATEN Vascular Graft configured for Pediatric ShuntBfArM
mdprc 016 06 21 001Delta Med spaMedical devices within shelf life that were sterilized at Steril Milano.BfArM
mdprc 028 06 21 000Accelerate Diagnostics IncAccelerate Pheno system.BfArM
mdprc 020 06 21 000G. Heinemann Medizintechnik GmbHMODULA series ENT treatment unitsBfArM
mdprc 007 06 21 000ConMed CorporationBuffalo Filter® LaparoVue® Visibility SystemBfArM
mdprc 003 06 21 000CeramOptec GmbH Sub biolitec AGFiLaC® Fistula Kit, LHP® Procedure Kit, HeLP® Procedure KitBfArM
mdprc 011 05 21 000WeinmannMEDUMAT Transport emergency and transport ventilatorsBfArM
mdprc 035 03 20 001Lowenstein Medical GmbH &Co.KGelisa 300, elisa 500, elisa 600, elisa 800 und elisa 800VITBfArM
mdprc 032 03 21 000PENTAX Europe GmbHMedical Auto Leakage Tester SHA-P6BfArM
mdprc 010 02 21 001SIEMENSSensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C PChttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=185684
mdprc 030 02 21 000Schiller AGFRED Easy defibrillator, FRED Easy Skity defibrillatorBfArM
mdprc 029 02 21 000Recipe Chemicals & Instruments GMBHClinCal Whole Blood Calibrator for ImmunosuppressantsBfArM
mdprc 025 02 21 000WeinmannMEDUMAT Transport emergency and transport ventilatorBfArM
mdprc 017 02 21 000Molnlycke Health Care AB.Mölnlycke® Procedure Trays & Single Packed Sterile TrocarsBfArM
mdprc 011 02 21 001Nihon Kohden Corporation.Multiple Patient ReceiversBfArM
mdprc 003 12 20 001Nipro Medical CorporationELISIO 17-H, ELISIO 19-H, and ELISIO 19-MBfArM
mdprc 021 01 21 000Likamed GmbHSELEXA bed chairBfArM
mdprc 007 01 21 000Unimax Medical Systems IncHasson TrocarBfArM
mdprc 022 10 20 001Molnlycke Health Care AB.Procedure Trays & Single Packed Shielded Bladed TrocarsBfArM
mdprc 021 12 20 000SIEMENSArtis zee/Q/Q.zen systems with software version VD11EBfArM
mdprc 016 12 20 000Medos Medizintechnik AG..Novatherm / Deltastream HCBfArM
mdprc 015 12 20 000ImplantcastEcoFit cup cementless / EcoFit cup EPORE cementlessBfArM
mdprc 013 12 20 000STERIS Corporation..Medisafe Distal Duck Kit and Duck Bag (Humidity Pack)BfArM
mdprc 012 12 20 000SIEMENSArtis icono and Artis pheno systems VE20BBfArM
mdprc 007 06 19 001Motek Medical B.VBody-Weight Support Light (BWS-L)https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=180473
mdprc 020 11 20 000Omixon Biocomputing LtdOmixon HLA Twin CE 4.2.0BfArM
mdprc 013 11 20 000Thermo Fisher Scientific OyBilirubin Direct, Bilirubin Total (NBD), Creatinine (Jaffe), Creatinine (Enzymatic)BfArM
mdprc 020 10 20 000Chirana T. Injecta, a.s.Sterile hypodermic / blunt fill needle - MEDOJECTBfArM
mdprc 036 09 20 000Armstrong Medical15mmØ Collapsible/Extendible Tubing in Catheter Mounts, Face Mask Kits and some Breathing CircuitsBfArM
mdprc 025 09 20 000Siemens Healthcare Diagnostics GmbHADVIA Centaur HER2 & Atellica IM HER2BfArM
mdprc 008 09 20 000SIEMENSSymbia S and T Series camera systemsBfArM
mdprc 019 08 20 001Globus Medical, IncALTERA spacerBfArM, Swissmedic
mdprc 021 08 20 000SIEMENSArtis zee and Artis Q systems …BfArM
mdprc 017 08 20 000WeinmannAll disposable patient hose systems without a BiCheck flow sensor for the MEDUMAT Transport emergency and transport ventilatorBfArM
mdprc 016 08 20 000Impulse Dynamics USA Inc.OMNI II Programmer with OMNI Smart Application SoftwareBfArM
mdprc 007 07 20 000Sunrise MedicalQuickie Q 700-UP M & Quickie Q 700-UP FBfArM
mdprc 030 06 20 000DexCom IncDexcom G4 PLATINUM and Dexcom G5 Mobile ReceiverBfArM
mdprc 024 06 20 000BD BiosciencesBBL Gram Crystal Violet Reagents and Gram Stain KitsBfArM
mdprc 005 06 20 000GS Elektromedizinische Geräte G. Stemple GmbHCorpuls CPRBfArM
mdprc 020 05 20 000Philips BurtonHeartStart XL Defibrillator/MonitorsBfArM
mdprc 011 05 20 000UTAK Laboratories, Inc.Trace Elements NRBfArM
mdprc 005 04 20 000Smiths Medical International LimitedLogiCal 5ml Closed Blood Sampling System Sets and HemoDraw Plus Closed Blood Sampling Sets with LogiCal Pressure Monitoring SystemBfArM
mdprc 031 03 20 000FUJIFILM Medical SystemsFCR Capsula X systemBfArM
mdprc 011 03 20 000Molnlycke Health Care AB.Molnlycke Procedure Trays..BfArM
mdprc 009 02 20 000Teleflex Medical..Arrow Epidural Catheterization Kits and SetsBfArM
mdprc 031 01 20 000Siemens Healthcare Diagnostics ProductIMMULITE 2000/IMMULITE 2000 XPi EBV-VCA IgMBfArM
mdprc 005 01 20 000VITREQ B.V.VitreQ Vitrectomy fluid/gas handling Instrument, VitreQ Ophthalmic infusion/aspiration cannula.BfArM
mdprc 042 12 19 000Biocartis NV.Idylla ctNRAS-BRAF Mutation TestBfArM
mdprc 019 12 19 000Shimadzu Medical Systems.FDR Go Mobile X-Ray SystemsBfArM
mdprc 115 02 18 001Eurogine S.L.Ancora 375 NormalBfArM
mdprc 051 11 19 000Cordis CorporationCordis S.M.A.R.T. and PRECISE StentsBfArM
mdprc 050 11 19 000NxStage Medical, Inc.System One Hemodialysis MachinesBfArM
mdprc 039 11 19 000ANIOS LABORATOIRESOPASTER ANIOSBfArM
mdprc 038 11 19 000ANIOS LABORATOIRESBACCIDE KIT PRO, ECI MND PREMIUM, INTRUNET SURFA SAFE PREMIUM, SURFA'SAFE PREMIUMBfArM
mdprc 019 11 19 000aap Implantate AG.LOQTEQ Distal Lateral Femur Plate PPBfArM
mdprc 018 11 19 001Allergan services international LimitedXEN Glaucoma Treatment SystemBfArM
mdprc 007 11 19 000Philips HealthcareHeartStart XL+ Defibrillator/MonitorBfArM
mdprc 002 10 19 000AesculapS4C OCCIPITAL PLATE SMALL 5 HOLESBfArM
mdprc 001 10 19 000Roche Diagnostics CorpTina-quant IgG Gen.2 on cobas c 503BfArM
mdprc 161 09 19 000EOVEEO-150 Car lighter DC cableBfArM
mdprc 160 09 19 000B Braun Surgical SAMONOPLUS VIOLET 0(3,5)150CM HR48 LOOP(M) DDPBfArM
mdprc 004 09 19 001TEM Innovations GmbHROTEM ex-temhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175611
mdprc 149 09 19 000Cooper Surgical, Inc.EMBRYOLOGY HEATED PLATE WITHIN THE RI WITNESSBfArM
mdprc 148 09 19 000adeor Medical AGMSI Biopsy InstrumentsBfArM
mdprc 147 09 19 000Boston Scientific LtdiLab Polaris Multi-Modality Guidance SystemBfArM
mdprc 146 09 19 000Medset Medizintechnik GmbHPatientcable for ECG Amplifier BT-12BfArM
mdprc 145 09 19 000Teleflex Medical..Rusch TracFlex Plus Phonation Set, Cuffed; Rusch TracFlex Plus Set, cuffed; TracFlex Plus PDT Set; Ruschcare TracFlex Plus Phonation Set, CuffedBfArM
mdprc 135 09 19 000ArcRoyalMedline International Sterile Absorbent Cotton O.R Towels that are included in AreRoyal procedure packsBfArM
mdprc 134 09 19 000Cook MedicalZenith Branch Iliac Endovascular Graft (ZBIS) - Patient Card BfArM
mdprc 133 09 19 000InnoTERE GmbHINNOTERE Paste-CPC, 3mlBfArM
mdprc 132 09 19 000Smith & Nephew incRT-PLUS MODULAR FEMORAL BLOCKBfArM
mdprc 131 09 19 000Teleflex MedicalRüsch DispoGrip Single-Use Standard Laryngoscope HandlesBfArM
mdprc 021 03 19 001DiaSys Diagnostic Systems GmbH.Reagent CRP FSSwissmedic
mdprc 120 09 19 000W.O.M. World of Medicine GmbH (hereafter “WOM” .Aquilex Fluid Control SystemsBfArM
mdprc 119 09 19 000Ecken & Ziegler BEBIG GmbHRu-106 AugenapplikatorenBfArM
mdprc 108 09 19 000Quality Electrodynamics, LLC (QED)TxRx Knee Coil 1.5T and 3T for Use on Siemens MR SystemsBfArM
mdprc 107 09 19 000JSC "MEDSIL"Medsil Intragastric BalloonBfArM
mdprc 106 09 19 000Johnson & Johnson Vision Care1-DAY ACUVUE MOIST for ASTIGMATISMBfArM
mdprc 091 09 19 000EndalisEndball Systeme de Ballon Intra-gastriqueBfArM
mdprc 090 09 19 000BSN medical (Pty) Ltd.CUTISOFT PACK Catheter Change SetBfArM
mdprc 089 09 19 000DENTSPLY InternationalDrill Extension for Astra Tech Implant SystemBfArM
mdprc 088 09 19 000Shimadzu Medical Systems.Flexavision F3BfArM
mdprc 070 09 19 000PAJUNK GmbH MedizintechnologieSPROTTE lumbal with IntroducerBfArM
mdprc 069 09 19 000Biomatrica, Inc.LBgard Blood Collection TubeBfArM
mdprc 068 09 19 000DRG Instruments GmbHSalivary Estrone ELISABfArM
mdprc 067 09 19 000Fresenius Medical Care.AV-SET B-R & AV-Set SRB-RBfArM
mdprc 066 09 19 000Kreatech Biotechnology BVPreImpScreen PolB (13 16 18 21 22)BfArM
mdprc 065 09 19 000Omni-Pac Ekco GmbHMediTainer, MediBowl, MediDuoBfArM
mdprc 064 09 19 000Siemens Healthcare Diagnostics GmbHAtellica IM anti-CCP IgG (aCCP) and Pregnancy-Associated Plasma Protein-A (PAPP-A)BfArM
mdprc 063 09 19 000The Binding SiteNK044.0PT- Optilite C-Reactive Protein Reagent.BfArM
mdprc 089 09 18 001Cordis CorporationPowerflex PRO PTA balloon dilation BfArM
mdprc 047 09 19 000LivaNova PLCSCP Control panel (Subset)BfArM
mdprc 046 09 19 000munevo GmbHmunevo DRIVEBfArM
mdprc 045 09 19 000Terumo Europe N.VTerumo Cardiopulmonary Extracorporeal Tubing Set Modular Perfusion Blood Circuit BfArM
mdprc 042 09 19 000Teleflex Medical..TrapLiner CatheterBfArM
mdprc 032 09 19 000Arjo HuntleighConcerto & Basic Shower Trolley.BfArM
mdprc 031 09 19 000Elekta IncMonaco RTP System....BfArM
mdprc 030 09 19 000GE HealthcareGiraffe OmniBed CarestationBfArM
mdprc 029 09 19 000Spierings Orthopaedics B.V.REX Cement StopBfArM
mdprc 028 09 19 000UROMED Kurt Drews KGUROMED catheterisation kits, CYSTOBAG and FLUXOBAGBfArM
mdprc 027 09 19 000Zimmer, INC….Calcar Trimmer ShaftBfArM
mdprc 026 09 19 000Zimmer, INC….Sidus Stem-Free Shoulder Humeral HeadBfArM
mdprc 025 09 19 000Medline Industries, Inc.Sterile Absorbent cotton O.R towelsBfArM
mdprc 024 09 19 000Smiths Medical International LimitedLogiCal Pressure Monitoring Option Kit, Clear, 150cmBfArM
mdprc 023 09 19 000Thermo Fisher Scientific Inc.ThermoScientific Oxoid Meropenem 32 M.I.C.E. strip, MA0121D&FBfArM
mdprc 022 09 19 000bioMerieux IncVIDAS FT4.BfArM
mdprc 021 09 19 000Howmedica Osteonics Corp.Triathlon Femoral Distal AugmentBfArM
mdprc 020 09 19 000Medipan GMBHMedizym T.R.A. humanBfArM
mdprc 012 09 19 000HIGH TECHNOLOGY PRODUCTS, SLCooltechnology DeviceBfArM
mdprc 065 08 19 000B Braun Medical IncSerofineBfArM
mdprc 053 08 19 000SENTINEL CH. SpALithium, Alinity c Lithium Reagent KitBfArM
mdprc 052 08 19 000Remel Inc.Salmonella paratyphi B-H phase 1 Flagellar antigenBfArM
mdprc 051 08 19 000Grace Medical IncCartilage Microtome Systems and Cartilage Microtome Replacement HandlesBfArM
mdprc 046 08 19 000SIEMENSSOMATOM go.Up, go.NOW, go.TOP, go.ALLBfArM
mdprc 045 08 19 000Shimadzu Medical Systems.Mobile X-Ray System MobileDaRt EvolutionBfArM
mdprc 044 08 19 000Roche Diagnostics Corpcobas t 511 and t 711 - Coagulation analyzer.BfArM
mdprc 011 08 19 000emotion fitness GmbH & Co. KGMotion cycle 600 med BfArM
mdprc 010 08 19 000ASSAmed GmbH10 Fr Oxygen CathetersBfArM
mdprc 090 07 19 000Elekta LimitediGUIDE 2.2BfArM
mdprc 089 07 19 000EPflex Feinwerktechnik GmbHGuidewire MR-Guide SFC-PTFET-150-260/14-035-klar-Platin-croco-sterilBfArM
mdprc 088 07 19 000ES-Medical ABC-10 ProbetestersBfArM
mdprc 087 07 19 000Limacorporate S.p.a.Discovery Elbow Humeral condyle kit (XS + Standard)BfArM
mdprc 086 07 19 000Magnosco GmbHDermaFCBfArM
mdprc 085 07 19 000PAUL HARTMANNMikrobac Virucidal TissuesBfArM
mdprc 084 07 19 000Richard Wolf GmbHE-Line Cutting Electrode 11.5Fr Mono 0 degrees ,BfArM
mdprc 083 07 19 000Roche Diagnostics CorpCOBAS INTEGRA 400 plus analyzerBfArM
mdprc 082 07 19 000Shenzhen MindrayBeneHeart D1BfArM
mdprc 081 07 19 000Vivomed GmbHNierenschale, Pappe (kidney bowl)BfArM
mdprc 080 07 19 000Xenios AGiLA activve Kits / iLA activve iLA KitBfArM
mdprc 003 07 19 001Edwards LifesciencesIntraClude Intra-Aortic Occlusion Devices NCMDR
mdprc 055 07 19 000Fast Track Diagnostics Luxembourg S.à.r.l.FTD Neuro 9BfArM
mdprc 054 07 19 000Fast Track Diagnostics Luxembourg S.à.r.l.FTlyo diverseBfArM
mdprc 053 07 19 000Ortho-Clinical DiagnosticsORTHO AutoVue Innova Ultra & VISION or VISION MaxBfArM
mdprc 052 07 19 000Samsung ElectronicsUltrasonic Diagnostic Apparatus WS80A and HS70ABfArM
mdprc 051 07 19 000SIEMENSLANTIS Oncology Information System Server..BfArM
mdprc 050 07 19 000Smiths Medical International LimitedGRIPPER and PORT-A-CATH NeedlesBfArM
mdprc 049 07 19 000Zimmer, INCGTS Trunnion RaspBfArM
mdprc 048 07 19 000aap Implantate AG.Basic insert for load drill guide, LOQTEQ® 4.5, round holeBfArM
mdprc 047 07 19 000AesculapNB797K - E.MOTION UC/PS TIB.PLAT.C'LESS µCAP T7RBfArM
mdprc 046 07 19 000Alere LTDAlere DDS2 Test KitsBfArM
mdprc 045 07 19 000B Braun Medical IncPERIFIX FILTER 0,2μM ISO NRFitBfArM
mdprc 044 07 19 000Fast Track Diagnostics Luxembourg S.à.r.l.FTD ACEBfArM
mdprc 010 07 19 000Johnson & Johnson Medical GmbHNeutrogena Light Therapy Acne Mask and Refill ActivatorBfArM
mdprc 009 07 19 000Beaver Visitec International LtdNucleus Hydrodissector [Sauter] Cannula 40x22mm(27Gx7/8in)BfArM
mdprc 008 07 19 000Laborie Medical TechnologiesSolar BlueBfArM
mdprc 007 07 19 000Smith & Nephew incLEGION Optima Cutting Block.BfArM
mdprc 104 06 19 000HUM GmbHAEROtube® - LK02-GB-MBfArM
mdprc 103 06 19 000Hager & Meisinger GmbHTitanium abutment cemented GH 5.5 mm BfArM
mdprc 102 06 19 000Elekta LimitediGUIDE 2.2 BfArM
mdprc 101 06 19 000Elekta IncElekta UnityBfArM
mdprc 100 06 19 000B Braun Medical Inc.Vasco-OP Sensitive Gr. 8,5 Sterile.BfArM
mdprc 095 06 19 000DiaSys Diagnostic Systems GmbH.Calibrator TruCal U BfArM
mdprc 094 06 19 000Siemens Healthcare DiagnosticsStratus CS Acute Care cTnI TestPakBfArM
mdprc 093 06 19 000Zimmer, INC….DVR Crosslock ePAK Screw Driver, DVR Crosslock ePAK Depth Gauge, K-Wire Trochar TipBfArM
mdprc 065 06 19 000Teleflex MedicalHudson RCI Air Cushion Face MaskBfArM
mdprc 064 06 19 000TEC COM GmbH.TECOtherm NEO.BfArM
mdprc 063 06 19 000Siemens Medical SolutionsCios Alpha VA20 /VA30 and Cios Fusion systemsBfArM
mdprc 062 06 19 000Philips Medical SystemsPhilips PageWriter TC Cardiographs (TC20/30/50/70)BfArM
mdprc 061 06 19 000MÖLLER-WEDEL GmbH & Co. KGThe software of the floor stands FS 2-21, FS 2-25, FS 3-45 in combination with the operating microscope HS Hi-R NEO 900/A /A NIRBfArM
mdprc 060 06 19 000GE HealthcareCentricity Universal Viewer with Centricity PACS Foundation 6.0 SP9 or HigherBfArM
mdprc 059 06 19 000Tornier Inc.No. sterile pin guideBfArM
mdprc 058 06 19 000Immundiagnostik AGIVD, IDKmonitor® lnfliximab ,IDKmonitor® Adalimumab, Remsima® Monitor , 25(0H)-Vitamin D direct day ELISA I K 2108 futurelots,BfArM
mdprc 057 06 19 000Hain Lifescience GmbHFluoroSoftware IVD used with FluoroCyclers 12 & 96BfArM
mdprc 056 06 19 000EKF DIAGNOSTIC GmbHQuo-Lab A1C Test Kit / PocketChem HbA1Cc Test KitBfArM
mdprc 101 05 19 001Medtronic SAInterStim Therapy Programmer Compatibility https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=172112
mdprc 027 06 19 000Cryotherm GmbH & CoBIOSAFE MD-smartBfArM
mdprc 026 06 19 000Pega MedicalSimple Locking lntramedullary (SLIM) System (SLM-HND100)BfArM
mdprc 025 06 19 000Nobel Biocare Services ABHealing Abutment CC RP Ø3.6x5mmBfArM
mdprc 024 06 19 000Lowenstein Medical GmbH &Co.KGIntensive Care Ventilators elisa 300, elisa 500, elisa 600, elisa 800 und elisa 800VITBfArM
mdprc 023 06 19 000AtriCure, Inc.EPi-Sense Coagulation Systems with VisiTraxBfArM
mdprc 022 06 19 000AesculapThe Disposable Fleece Drape F/GA419/GD417/GD421BfArM
mdprc 011 06 19 000Edan Instruments IncHolter System V1.22&V1.23 Analysis Software BfArM
mdprc 010 06 19 000EIT Emerging Implant Technologies GmbHImplant Inserter S. ConnectionBfArM
mdprc 009 06 19 000Fluoron GmbHBrilliant PeelBfArM
mdprc 008 06 19 000Lifetech Scientific (Shenzhen) Co., Ltd.Cera Vascular Plug SystemBfArM
mdprc 006 06 19 000Neuromedex GmbH4 mm SECURODRAIN and 4 mm NeuroVac Silicone Flat DrainsBfArM
mdprc 005 06 19 000Philips HealthcarePhilips Access CT SystemsBfArM
mdprc 004 06 19 000Primed Halberstadt Medizintechnik GmbHSinapi Chest Drainage RangeBfArM
mdprc 003 06 19 000WIROS Wilfried Resbach GmbHcare&serve| premium| wooden tongue depressor | naturalBfArM
mdprc 106 05 19 000bioMerieux IncVIDAS NT-proBNP2BfArM
mdprc 105 05 19 000Biotype Diagnostik GmbHMentype AMLplexQSBfArM
mdprc 104 05 19 000AbbottCELL-DYN Emerald; Emerald Diluent Tubing BfArM
mdprc 103 05 19 000CLERADGAMMA SUPIIBfArM
mdprc 102 05 19 000CODAN Medizinische Geraete GmbH & Co KGArterial Blood Sampling SystemBfArM
mdprc 066 05 19 000LAWTON GmbH & Co., KGLeyla Flexible ArmsBfArM
mdprc 065 05 19 000GE HealthcareCT, PET-CT, and SPECT-CT Scanners BfArM
mdprc 064 05 19 000Edwards LifesciencesSwan-Ganz Thermodilution Catheter Double LumenBfArM
mdprc 063 05 19 000Diagnostica StagoSTA-NeoPTimal 20 with STA-Compact/STA-Compact MaxBfArM
mdprc 062 05 19 000Boston Scientific Corporation..Various Precision and Vercise Adapters, Leads, Lead Extensions, and KitsBfArM
mdprc 067 08 18 001Draeger Medical Systems IncThe Infinity M30Ö+BfArM
mdprc 056 05 19 000HUGH STEEPER LTDSelect Myoelectric HandsBfArM
mdprc 055 05 19 000AesculapCAIMAN DISP.INSTR.ARTICULAT.D:12/240MM /440MMBfArM
mdprc 054 05 19 000Institut StraumannTempImplant ø 2.0mm, L 12.0mm, TiBfArM
mdprc 053 05 19 000Teleflex Medical..Mobile SL, Ch 12, Ch 14, ErgothanBfArM
mdprc 052 05 19 000VON ARDENNE GmbHIRATHERM1000 with IRAcom transducerBfArM
mdprc 050 05 19 000EBR Systems, INCWiSE CRT Electrode and Delivery CatheterBfArM
mdprc 049 05 19 000Endo Tools Therapeutics SATAPES endoscopic suturing deviceBfArM
mdprc 048 05 19 000EtacSize 3 Wombat Living Assistive Ergonomic ChairsBfArM
mdprc 047 05 19 000Icare Finland OyVENTICA skin electrodeBfArM
mdprc 036 05 19 000MÖLLER-WEDEL GmbHCeiling unit CU 3-5x in combination with the operating microscope HS Hi-R NEO 900 / A / A NIRBfArM
mdprc 035 05 19 000Beaver Visitec International LtdBVI Ophthalmic Instrument Wipes, Wicks and Corneal Light Shield Sponge ProductsBfArM
mdprc 034 05 19 000CAIR LGLHeat exchanger and adult infusion set with filter and needle-free injection site- TEIDE 150BfArM
mdprc 033 05 19 000MathystwinSys impactor with offsetBfArM
mdprc 032 05 19 000NabtescoNI-C311 Energy Hybrid KnieBfArM
mdprc 031 05 19 000Ortho Organizers IncMaestro .018 UL1 Orthodontic BracketBfArM
mdprc 030 05 19 000TVA Medical, Inc.4 Fr EverlinQ EndoAVF SystemBfArM
mdprc 010 05 19 000WeinmannMEDUCORE Standard 2.BfArM
mdprc 006 05 19 000AesculapPL770SU - CAIMAN MARYLAND NON ARTICULAT.D5/360MMBfArM
mdprc 005 05 19 000Arrow International IncTwo-Lumen Central Venous Catheterization Kit/ - Set with Blue Flex Tip CatheterBfArM
mdprc 004 05 19 000Vermeiren N.V.Rapido; Squod; Forest II; Forest Kids; ExpressBfArM
mdprc 003 05 19 000MSP Medizintechnik GmbHHSO SafeHeat Hand WarmerBfArM
mdprc 129 04 19 000Avanos Medical IncMIC* Gastric‐Jejunal Feeding Tube (18 Fr)BfArM
mdprc 128 04 19 000Microline Surgical IncTLS2 35cm Thermal Ligating ShearsBfArM
mdprc 127 04 19 000nal von minden GmbHDrug-Screen Multi 3XA , Multi 8XA, Multi 9XA, BZDBfArM
mdprc 126 04 19 000R-Biopharm AGRIDA QUICK ADM MonitoringBfArM
mdprc 125 04 19 000Thermo Fisher Scientific Inc.Bacillus cereus Medium (MYP)BfArM
mdprc 118 04 19 000Samsung ElectronicsSamsung Mobile Digital Batteries X-ray Units GM85BfArM
mdprc 117 04 19 000HELLMUT RUCK GmbHPodolog Stella 2 und 3 BfArM
mdprc 110 04 19 000Baxter HealthcareArtiSet HD BfArM
mdprc 109 04 19 000Leonhard Lang GmbHDefibrillation Electrode SCHILLER BfArM
mdprc 104 04 19 000Elekta Inc.Elekta Unity BfArM
mdprc 101 04 19 000POSEY PRODUCTS, LLCPosey Connected Twice-as-Tough Cuffs BfArM
mdprc 100 04 19 000MEDICEM Technology s.r.o.Dilapan-5- Hygroscopic cervical dilator BfArM
mdprc 099 04 19 000free life medical GmbHRevas"- Dual Lumen cannula, REVAS Venous Femoral cannula, REVAS' Universal ECLS cannula V/A, and REVAS Venous Femoral cannula pre-bent tip BfArM
mdprc 076 04 19 000bess pro gmbhaixstent Duodenum TTSBfArM
mdprc 075 04 19 000bioMerieux IncVITEK 2: AST-N254 , AST-N330, AST-N371 test kitsBfArM
mdprc 074 04 19 000Biosynex S.A.PALUTOP +4 OPTIMABfArM
mdprc 073 04 19 000DENTSPLY InternationalANKYLOS Tri-Spade Drill GS A8BfArM
mdprc 072 04 19 000EKOS CorpEKOS Control System 4.0 - Connector interface cablBfArM
mdprc 071 04 19 000Molnlycke Health Care AB.Component Neuro swab in Molnlycke Procedure traysBfArM
mdprc 070 04 19 000Schiller AGDefigard Touch 7.BfArM
mdprc 069 04 19 000Schutz Dental GroupSebond ImplantBfArM
mdprc 068 04 19 000Withings SasNokia BPM+ - Wireless Blood Pressure MonitorBfArM
mdprc 054 04 19 000Vepro AGEMR Manager (PACS)BfArM
mdprc 053 04 19 000Dornier MedTech GmbHDornier Standard Diode and Nd:YAG LightguidesBfArM
mdprc 047 04 19 0003M Health Care Ltd3M Reston Self-Adhering Foam PadsBfArM
mdprc 046 04 19 000BEKA Hospitec GmbHAlu CARLO ClassicBfArM
mdprc 045 04 19 000BMV Bender Medical Vertrieb GmbHBMV Filterkassette highflow/TRACHEOCUR HME Cassette HighflowBfArM
mdprc 044 04 19 000MAQUET IncCustom Tubing setBfArM
mdprc 043 04 19 000Meda Pharma S.p.A.Endwarts Classic solution in bottle of 3mlBfArM
mdprc 042 04 19 000PROCEPT BioRobotics CorporationAQUABEAM HandpieceBfArM
mdprc 041 04 19 000Smith & Nephew incVLP MINI-MOD 2.0MM STRAIGHT PLATE 6 HOLEBfArM
mdprc 043 02 19 001MGB Endoskopische Gerate GmbH BerlinGRP Handles.BfArM, Swissmedic
mdprc 030 04 19 000Viewray IncorporatedMRIdian Linac SystemBfArM
mdprc 029 04 19 000Tosoh CorporationS. AIA-PACK ACTHBfArM
mdprc 028 04 19 000Medset Medizintechnik GmbHPADSY-Holter with the Holter-ECG Systems Sirius and Antares with LiveECG RecorderBfArM
mdprc 027 04 19 000Invacare Corporation…Shark Power Module exchangeBfArM
mdprc 026 04 19 000Geistlich Pharma AGGeistlich Bio-Oss PenBfArM
mdprc 025 04 19 000GE HealthcareDetector Mounting Screws for Nuclear Medicine SystemsBfArM
mdprc 024 04 19 000GE HealthcareAIR Anterior ArrayBfArM
mdprc 023 04 19 000Draeger Medical Systems IncVentStar Helix heated breathing circuits and Set2goBfArM
mdprc 022 04 19 000Brainlab AGBrainlab RT Elements Radiation Treatment Planning SoftwareBfArM
mdprc 021 04 19 000BioFire Diagnostics IncFilmArray Blood Culture Identification Panels.BfArM
mdprc 010 04 19 000ARB Medical LLCRebound HRD / HRD-VBfArM
mdprc 008 04 19 000EBR Systems, INCWiSE CRT TransmitterBfArM
mdprc 007 04 19 000Hoggi GmbHWheelchair CLEO TiBfArM
mdprc 005 04 19 000Luminex Molecular Diagnostics IncARIES productsBfArM
mdprc 004 04 19 000ORGENTEC Diagnostika GmbHORGENTEC ENAcombi ELISA, ORG 514BfArM
mdprc 092 03 19 000Peter BrehmTRIAL Titanium Shell left with strap 60 mmBfArM
mdprc 091 03 19 000Philips HealthcareMobileDiagnost wDR ,NCMDR
mdprc 071 03 19 000Teleflex MedicalGibeck HME Filter + Catheter Mount, RUSCH Connectors Bulk for Breathing CircuitBfArM
mdprc 045 03 19 001Ethicon Inc.VICRYL Suture and VICRYL Plus Suture Productshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00390-1
mdprc 052 03 19 000LivaNova PLC3T Heater-Cooler Systems.BfArM
mdprc 051 03 19 000MathysbalanSys Femur HolderBfArM
mdprc 050 03 19 000PREVOR GmbHPREVIN- MINI-TAD & MIKRO-TADBfArM
mdprc 049 03 19 000Viewray IncorporatedTreatment Planning and Delivery Software (TPDS) in use with the MRIdian SystemBfArM
mdprc 048 03 19 000Zimmer, INC….LactoSorb System 14mm Rapid FlapBfArM
mdprc 047 03 19 000Christoph Miethke GmbH & Co. KGBohrloch Reservoir Set, Ventricular CatheterBfArM
mdprc 046 03 19 000Elekta IncElekta Unity.BfArM
mdprc 044 03 19 000Hain Lifescience GmbHGXT NA Extraction KitBfArM
mdprc 043 03 19 000IBL International GmbH..Echinococcus lgG ELISA, RE56201BfArM
mdprc 034 03 19 000B Braun Medical IncINTRAPUR NEONAT I.V.FILTER 0.2MICRONBfArM
mdprc 064 02 19 001SIEMENSUROSKOP OMNIA and UROSKOP OMNIA MAXhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171137
mdprc 022 03 19 000AesculapACCULAN 4 OSCILLATING SAW STRAIGHTBfArM
mdprc 020 03 19 000Fast Track Diagnostics Luxembourg S.à.r.l.FTD 10.2 Fever and rashBfArM
mdprc 019 03 19 000Medovent GmbHReaxon Direct, Reaxon Nerve GuideBfArM
mdprc 018 03 19 000The Binding SiteNK044.OPT - Optilite C-Reactive Protein ReagentBfArM
mdprc 015 03 19 000PARIPARI LC SPRINT TracheoBfArM
mdprc 127 02 19 000Smith & Nephew incSmartStitch PerfectPasser ConnectorBfArM
mdprc 126 02 19 000MicroVention Europe S.A.R.L.LifePearl microspheresBfArM
mdprc 125 02 19 000GE HealthcareECG trunk cableBfArM
mdprc 123 02 19 000Applied Medical ResourcesGelPOINT Path Transanal Access PlatformBfArM
mdprc 122 02 19 000B Braun Medical IncDialog iQ HD, Dialog iQ HD comfort und Dialog iQ HDF comfort Dialysis MachinesBfArM
mdprc 121 02 19 000Brainlab AGBrainlab Spine & Trauma 3D Navigation 1.0BfArM
mdprc 114 02 19 000S.KONSTANTINIDIS & CO LTDFLOATABLE PLASTIC BACK/ SPINAL-BOARD NEPTUNE STRETCHER FOR HORIZONTAL TRANSFERBfArM
mdprc 113 02 19 000STRATEC Biomedical Systems AGStratec GEMINI und Stratec GEMINI ComboBfArM
mdprc 112 02 19 000Smith & Nephew incSMF Stem With StiktiteBfArM
mdprc 111 02 19 000Siemens Healthcare Diagnostics ProductEnzygnost Syphilis.BfArM
mdprc 110 02 19 000Siemens Healthcare Diagnostics GmbHHVN Mech Automation Kits Used with ADVIA Chemistry XPT SystemsBfArM
mdprc 109 02 19 000One Lambda IncUniMatch Plus SoftwareBfArM
mdprc 108 02 19 000Dongguan Bosh Biotechnologies, Ltd.t-PSA Rapid Test / Free PSA Rapid TestBfArM
mdprc 107 02 19 000EKF DIAGNOSTIC GmbHDiaSpect Hemoglobin T-LOW analyzerBfArM
mdprc 106 02 19 000GDF Gesellschaft für Dentale Forschung und Innovationen GmbHZirkon PrimerBfArM
mdprc 105 02 19 000IBL International GmbH..DHEA ELISABfArM
mdprc 104 02 19 000New Oncology GmbHNEOselect, NEOonsite - Data Analysis & NEOdbBfArM
mdprc 103 02 19 000Immunodiagnostic Systems LimitedIDS-iSYS ACTHBfArM
mdprc 102 02 19 000ALTERA TIBBI MALZEME SAN. VE TIC. A.SSeptiflow CircuitBfArM
mdprc 101 02 19 000Becton Dickinson & Co. (BD)BD MAX Enteric Bacterial PanelBfArM
mdprc 100 02 19 000Biotype Diagnostik GmbHMentype MycoDermQS Lateral Flow.BfArM
mdprc 098 02 19 000Cisbio BioassaysAldosterone ALDO-RIACT;T4 OCPG07-T4 and OCPG57-T4; FPSA FPSA-RIACT;PSA PSA-RIACT;Chromogranine A CGA-RIACT; T3 OCPE7-T3 and OCPE57-T3;Chromogranine A CGA-Elisa (Protocole long)BfArM
mdprc 094 02 19 000Sequent Medical, Inc.WEB Detachment ControllerBfArM
mdprc 093 02 19 000Dr. Fooke-Achterrath Laboratorien GmbHIgG4 Food-Screening – Conjugate KitBfArM
mdprc 082 02 19 000Goodman Co., Ltd.NSE PTA Balloon Catheter GDM01BfArM
mdprc 067 02 19 000AesculapENDURO SPECIAL KEY TIB.LOCK.RING F1/10MMBfArM
mdprc 066 02 19 000Bucher Leichtbau AGEMS StretcherBfArM
mdprc 065 02 19 000Dr. Heni Software GmbH & Co. KGZenzy 2.46 softwareBfArM
mdprc 047 12 18 002Implant Direct Sybron Manufacturing,LLCInterActive Precision IO Scan Adapterhttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01610-1
mdprc 063 02 19 000VOMED Volzer Medizintechnik GmbH & Co. KGGRP handles with and without ratchetBfArM
mdprc 056 02 19 000Cook Endoscopy.Hemospray Endoscopic HemostatBfArM
mdprc 055 02 19 000ICU Medical, IncSAPPHIRE IV administration setsBfArM
mdprc 054 02 19 000Nidek Co. Ltd.Specular Microscope CEM 530BfArM
mdprc 053 02 19 000PROTEC GmbH & Co. KGPROGNOST ES / PROGNOST FS / PROGNOST S / PROVERTBfArM
mdprc 048 12 18 001Henry Schein, Inc..Henry Schein CU-1000 Halogen Lighthttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168772
mdprc 041 02 19 000MetranR100 Patient SetBfArM
mdprc 040 02 19 000Elekta IncMonaco RTP SystemBfArM
mdprc 039 02 19 000BONALIVE BIOMATERIALS LTD.Bonalive putty MIS, System pack and Single packBfArM
mdprc 038 02 19 000Technogenetics s.r.l.TGS TA EBV CSBfArM
mdprc 037 02 19 000Roche Diagnostics CorpBM-Lactate, LACT Accutrend Plus systemBfArM
mdprc 036 02 19 000Institut Virion/ Serion GmbHImmunomat InstrumentBfArM
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mdprc 022 02 19 000Innovative Design Orthopaedics LimitedVerso Shoulder Humeral Shells and Verso Shoulder Stemmed HumeralBfArM
mdprc 021 02 19 000Philips HealthcareHemodynamic Application R1.0.1BfArM
mdprc 020 02 19 000Stryker Trauma AGInstrument Tray, Basic T2 Femur LongBfArM
mdprc 019 02 19 000Wittenstein intens GmbHFitbone TAABfArM
mdprc 090 01 19 000Ziehm Imaging GmbH.Ziehm Vision RFD; Vision RFD 3D; Ziehm Solo FDBfArM
mdprc 088 01 19 000Caesarea Medical Electronics LtdT34 Ambulatory Syringe Pumps .BfArM
mdprc 087 01 19 000B. Braun MelsungenCelsite ® ImplantofixBfArM
mdprc 085 01 19 000Philips Healthcarelngenuity TF PET/CT running software version 4.0.2BfArM
mdprc 080 01 19 000Silikon-Technik Siltec GmbH & Co. KGSilicone tubesBfArM
mdprc 065 01 19 000Streifeneder ortho.production GmbHArtikon.genu-bi-lock System-KneeJoint Set with locking mechanismBfArM
mdprc 064 01 19 000GE HealthcareSenographe Crystal NovaBfArM
mdprc 063 01 19 000aap Implantate AG.Lambotte chisel, 20mnnBfArM
mdprc 051 01 19 000Roche Diagnostics Corpcobas t 511 and t 711 - Coagulation analyzerBfArM
mdprc 048 01 19 000Elekta IncElekta UnityBfArM
mdprc 047 01 19 000Gebrueder Martin GmbH & Co KG ,monopolar electrode handles smartPen for active electrodes with 2.4 mm attachmentBfArM
mdprc 046 01 19 000EKF DIAGNOSTIC GmbHQuo-Test A1C Test KitBfArM
mdprc 084 07 18 002ConvaTecSuction Catheters, Gastro-enteral TubesNCMDR
mdprc 040 01 19 000Smith & Nephew incJOURNEY DCF AP Femoral Cutting Block Size 3BfArM
mdprc 039 01 19 000Vertex-Dental B.V.Orthoplast 910 Violet (1L)BfArM
mdprc 038 01 19 000Zimmer, INCAllofit Alloclassic Screw PlugBfArM
mdprc 034 01 19 000Zimmer, INCMobi-C Cervical Disc ProsthesisBfArM
mdprc 033 01 19 000Schülke & Mayer GmbHoctenidol md mouthwashBfArM
mdprc 032 01 19 000Merge Healthcare Corp.Merge Eye Station Excessive Electrical OutputBfArM
mdprc 031 01 19 000Cochlear AGBaha 5 Sound Processor Tamper-proof battery door 3BfArM
mdprc 030 01 19 000SIEMENSIONTRISBfArM
mdprc 132 12 18 000DENTSPLY InternationalSiroLaser BlueBfArM
mdprc 131 12 18 000ImplantcastBIOLOX delta - cup insert Ø 36/44 mmBfArM
mdprc 130 12 18 000Otto Bock Healthcare Products GmbHPush Valve / Mag ValveBfArM
mdprc 129 12 18 000Schiller AGCARDIOVIT MS-2007; MS-2010; MS-2015BfArM
mdprc 128 12 18 000Howmedica Osteonics Corp.Tritanium Posterior Lumbar (PL) cageBfArM
mdprc 127 12 18 000StrykerNära Hospital BassinetsBfArM
mdprc 086 12 18 000Shenzhen Jumper Medical Equipment Co., Ltd.AngelSounds JPD-100S4 Fetal DopplerBfArM
mdprc 085 12 18 000OHST Medizintechnik AGCeramic femoral heads and Ceramic cup insertsBfArM
mdprc 084 12 18 000Natus NeurologyNicolet EEG Wireless AmplifierBfArM
mdprc 083 12 18 000Fresenius Medical Care.multiFiltratePRO device (M205001)BfArM
mdprc 082 12 18 000Carl Zeiss Meditec IncVisuMax 2.10.13BfArM
mdprc 043 12 18 001Vygon UK LtdDUALSTOPBfArM
mdprc 062 10 18 001Richard Wolf GmbHTEXAS Bronchoscope TubeBfArM, NCMDR
mdprc 057 11 18 001Civco Medical Instruments IncL25 Needle Guide Brackethttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168897
mdprc 050 12 18 000curasan AGCuravisc, Hyaluronic Acid 1%BfArM
mdprc 049 12 18 000Elekta IncMOSAIQ release version 2.64 SP9 and higherBfArM
mdprc 046 12 18 000Nausicaa Medical S.A.SBlue Flyer Compact hoistsBfArM
mdprc 045 12 18 000SIEMENSBiograph Horizon’s Oversized CT Circuit BreakerBfArM
mdprc 044 12 18 000SIEMENSSENSIS Vibe ComboBfArM
mdprc 042 12 18 000Waldemar LINK GmbH & CoMP Prosthesis stem cementlessBfArM
mdprc 040 12 18 000B Braun Medical IncActreen Lite NelatonBfArM
mdprc 039 12 18 000Arthrex, IncNano Corkscrew Suture Anchors ,BfArM
mdprc 038 12 18 000Acutronic Medical Systems AG.fabian Therapy evolution / fabian +nCPAP evolutionBfArM
mdprc 037 12 18 0003Shape Medical A/SX1 scannerBfArM
mdprc 096 11 18 000Dr. Gerhard Mann chem. - pharm. Fabrik GmbHArtelac Rebalance EDO /Artelac Rebalance SDUBfArM
mdprc 095 11 18 000gabmedgabControl, Hitado, DiaTest, IDEAL H. pyloriBfArM
mdprc 094 11 18 000Immucor GmbH.PakAutoBfArM
mdprc 093 11 18 000IMRIS Inc.Operating Room Tables (T2X, ORT1 00, ORT200, ORT300)BfArM
mdprc 092 11 18 000Medtronic SAMedtronic StrataMR Guider ToolBfArM
mdprc 091 11 18 000megro GmbH & Co. KGRatiomed H. pyloriBfArM
mdprc 089 11 18 000nal von minden GmbHNADAL PROM Amniotic fluid TestBfArM
mdprc 088 11 18 000ORGENTEC Diagnostika GmbHORG 242G Anti-alpha-Fodrin IgG BfArM
mdprc 087 11 18 000ORGENTEC Diagnostika GmbHORG 243M Anti-Annexin V IgMBfArM
mdprc 086 11 18 000Sartorius Stedim Biotech GmbHMinisart NMLBfArM
mdprc 085 11 18 000SciCan Ltd.Salus-10-AM-EUBfArM
mdprc 084 11 18 000Spineway SAMont blanc MIS, Posterior fusion minimal invasive spine surgeryBfArM
mdprc 083 11 18 000Thermo Fisher Scientific Inc.Oxoid Brilliance VRE Agar Oxoid Brilliance VRE AgarBfArM
mdprc 082 11 18 000Waldemar LINK GmbH & CoBiMobile Cup C, Liner, UHMWPE BfArM
mdprc 060 11 18 000PRODENE KLINT LABORATOIRESNOSOCOMIA PREDESINFECTANT INSTRUMENTSBfArM
mdprc 059 11 18 000Philips HealthcareFlex Cardio (Model FC2010) devices BfArM
mdprc 058 11 18 000Noventure S.L.UTIPRO PLUSBfArM
mdprc 066 10 18 001DT MedTechH3 Poly Inlayhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168103
mdprc 044 11 18 000OSTEOGENICS BIOMEDICAL,INC. .ZCORE Porcine Xenograft ParticulateBfArM
mdprc 043 11 18 000Southmedic IncUresta Bladder SupportBfArM
mdprc 042 11 18 000Molnlycke Health Care AB.Mölnlycke® Suction & Irrigation SetBfArM
mdprc 041 11 18 000Gebr. Brasseler GmbH & Co KG (Business Unit Komet Medical)Saw blades for bone surgery for single use -STERILE BfArM
mdprc 040 11 18 000Eurovema ABFlexmobil Forma, Miniflex FormaN/A BfArM
mdprc 031 11 18 000Zimmer Biomet, Inc.Avenir Muller Stem (Std./Lateral)BfArM
mdprc 030 11 18 000Stephanix S.A.SP4S, SP4S option AT, SP4S option APBfArM
mdprc 067 09 18 001Recipe Chemicals & Instruments GMBHClinRep Complete Kit for Antiepileptics in Serum / Plasma with UHPLCBfArM, Swissmedic
mdprc 015 11 18 000ENDO-FLEX GmbHTransbronchial Aspiration Needle SUBfArM
mdprc 014 11 18 000EUROSPINE SARLCervical locking cage + Lumbar locking cageBfArM
mdprc 013 11 18 000Sunray Medical Apparatus Co., LtdMatemal and Fetal MonitorBfArM
mdprc 011 11 18 000B Braun Medical IncNOVOSYN VIOLET 3/0(2)4X70CM HR22TOBfArM
mdprc 010 11 18 000CODAN Medizinische Geraete GmbH & Co KGCODAN Guard V86, V86-RBfArM
mdprc 009 11 18 000Philips HealthcarePhilips Prodiva MRI SystemBfArM
mdprc 008 11 18 000Stephanix S.A.D2RS / DX-D800 / Visionary DRFBfArM
mdprc 007 11 18 000Trivascular IncOvation, Ovation Prime, and Ovation IX Abdominal Stent Graft SystemsBfArM
mdprc 002 11 18 000Hanse-Medizintechnik Dipl. Ing. P. Hettmer GmbHMobilisations-Reharollstuhl TheklaBfArM
mdprc 001 11 18 000Randox Laboratories Ltd.Liquid Cardiac ControlsBfArM
mdprc 177 10 18 000IBL International GmbHYersinia enterocolitica IgA ELISABfArM
mdprc 176 10 18 000IRIS DiagnosticsiChem VELOCITY Chemistry StripsBfArM
mdprc 175 10 18 000Maquet Cardiopulmonary AGQUADROX-i Neonatal Microporous Membrane OxygenatorBfArM
mdprc 174 10 18 000MediRoxOwren's PTBfArM
mdprc 173 10 18 000MetaSystemsXL t(3;3) GATA2/MECOM DFBfArM
mdprc 172 10 18 000Proxomed Medizintechnik GmbHcompass 530 butterfly/butterfly reverse deviceBfArM
mdprc 171 10 18 000Roche Diagnostics CorpElecsys FT4 IIIBfArM
mdprc 170 10 18 000Bard Pcripheral Vascular (BPV)ePTFE Small Beading Vascular Graft ProductsBfArM
mdprc 072 12 17 001Draeger Medical Systems IncFabius with Auxiliary Common Gas Outlet (ACGO)BfArM, NCMDR
mdprc 146 10 18 000Air Liquide Medical SystemsTERMINAL UNIT BM O2 NFBfArM
mdprc 145 10 18 000ICU Medical, IncThermoset Injectate Delivery SystemsBfArM
mdprc 144 10 18 000Jarvik Heart Inc.Jarvik 2000 Heart, JHI-212 Y Cable, JHI-202 Lithium-ion Battery Cable, JHI-201 Pedestal Cable, JHI-204 Extension CableBfArM
mdprc 143 10 18 000SIEMENSArtis zee biplane and Artis Q biplaneBfArM
mdprc 104 10 18 000Zimmer, INCAffixus Hip Fracture Nails.BfArM
mdprc 103 10 18 000AngioDynamics IncNANOKNIFE DISPOSABLE SINGLE ELECTRODE PROBESBfArM
mdprc 102 10 18 000Corvia Medical, Inc.Inter-atrial Shunt Device (IASD) System IIBfArM
mdprc 101 10 18 000EtacParking brake for wheelchairsBfArM
mdprc 100 10 18 000Fritz Stephan GmbHSpO2-Controller "SP02C" of the ventilator SOPHIEBfArM
mdprc 099 10 18 000Hager & Meisinger GmbHTitanbase MyPlant IIBfArM
mdprc 098 10 18 000Herbert Waldmann GmbH & Co. KGUV THERAPY SYSTEM UV 7001BfArM
mdprc 097 10 18 000icotec AGDrill, AO Coupling, Ø 3 mm for 13 mm screwBfArM
mdprc 096 10 18 000Limacorporate S.p.a.Revision femoral head #L, #XLBfArM
mdprc 095 10 18 000Oscor Inc.TB-Temporary Bipolar Pacing LeadsBfArM
mdprc 094 10 18 000SIEMENSEvo Excel ECG Power OutletBfArM
mdprc 093 10 18 000Smiths Medical ASD IncLevel 1 Foley Catheters with Temperature SensorsBfArM
mdprc 070 10 18 000ABIOMED IncImpella Heart PumpsBfArM
mdprc 069 10 18 000Arthrex, IncLi-Ion Battery Housings for DrillSaw Sports 400 SystemsBfArM
mdprc 068 10 18 000Balt ExtrusionSILK+ / VASCO+BfArM
mdprc 067 10 18 000CRYO DIFFUSION S.A.S.CONTAINERS, Cryogenic tanksBfArM
mdprc 065 10 18 000General Medical Merate SpAFMI gear kit, GMM Tables starting from serial number 010/313 until serial number 33130BfArM
mdprc 064 10 18 000Medtronic SAModel 37604 Activa PC+S Implantable NeurostimulatorsBfArM
mdprc 063 10 18 000Molnlycke Health Care AB.Mon-a-ThermT Foley catheters with temperature sensorsBfArM
mdprc 061 10 18 000SIEMENSArtis zee ceiling systems.BfArM
mdprc 060 10 18 000Zimmer Biomet, Inc.Avantage Acetabular Shell Inserter Instrument for hipBfArM
mdprc 059 10 18 000Zimmer Biomet, Inc.StageOne Select, Hip Cement Spacer MoldsBfArM
mdprc 028 10 18 000Becton Dickinson & Co. (BD)Micro-Fine Ultra 0,25mm (31G) x 5mmBfArM
mdprc 027 10 18 000CooperSurgical Inc..Single-Use, Colpo-Pneumo OccluderBfArM
mdprc 026 10 18 000ekamed GmbH & Co. KGekamove 300 lateral positioning systemsBfArM
mdprc 025 10 18 000Inpeco S.A.FlexLab AutomationBfArM
mdprc 024 10 18 000Lsi Medience Corporationhs-cTnl Reagents Used with PATHFAST Type-D AnalyzersBfArM
mdprc 127 09 18 000Heinz Kurz GmbHKURZ-PRECISE Cartilage CutterBfArM
mdprc 126 09 18 000StrykerALTRIX, 220-240V/50HZBfArM
mdprc 125 09 18 000Victory ImplantsDiverse DentalimplantateBfArM
mdprc 091 09 18 000Alpha Omega Engineering Ltd.Neuro OmegaBfArM
mdprc 090 09 18 000Boston Scientific LATITUDE Programmer BfArM
mdprc 076 09 18 000Beckman CoulterEnzymatic Creatinine OSR6x204, HDL Cholesterol OSR6x87, Lipase OSR6x30 and Uric Acid OSR6x98BfArM
mdprc 075 09 18 000Coltene Whaledent Inc.Unity Drill Assembly Unit, .021BfArM
mdprc 074 09 18 000Dako North America IncFLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294BfArM
mdprc 073 09 18 000icotec AGCannulated Tap, 5.5 mmBfArM
mdprc 072 09 18 000Implant Direct Sybron Manufacturing,LLCRePlant Precision IO Scan AdapterBfArM
mdprc 071 09 18 000Mediplus Ltd Various Brand of Peripheral Venous CatheterBfArM
mdprc 070 09 18 000Medos Medizintechnik AGpump head s.pumpBfArM
mdprc 069 09 18 000Medtronic SACovidien EEA Circular Staplers with Tri-Staple TechnologyBfArM
mdprc 068 09 18 000Philips HealthcareXper Flex Cardio Physiomonitoring System.BfArM
mdprc 066 09 18 000Sunny Medical Device (Shenzhen) Co., Ltd.Haemostatic ValvesBfArM
mdprc 060 09 18 000Accuray IncCyberKnife Robotic Radiosurgery SystemBfArM
mdprc 059 09 18 000B Braun Medical IncIntrafix SafeSet Standard, 180 cmBfArM
mdprc 058 09 18 000Becton Dickinson & Co. (BD)Alaris / Asena CC, GH Syringe PumpBfArM
mdprc 057 09 18 000Cook Medical Europe LimitedZenith Alpha Thoracic Endovascular GraftsBfArM
mdprc 056 09 18 000EOVEEO‐150 ventilatorBfArM
mdprc 055 09 18 000Hill Rom IncStrap Gripper, for Liko MultiRall 200BfArM
mdprc 054 09 18 000IBL International GmbHIgG4 Food Screen 280 ELISABfArM
mdprc 053 09 18 000IBL International GmbHTaenia solium lgG ELISABfArM
mdprc 052 09 18 000Ovesco Endoscopy AGAWC-Additional Working ChannelBfArM
mdprc 051 09 18 000Scopis GmbHMayfield trackerBfArM
mdprc 050 09 18 000WickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd. (WickiMed Supply Company Ltd.)Sterile single use electrosurgical pencil/HCP-05BfArM
mdprc 049 09 18 000Zimmer Biomet, Inc.T.E.S.S Glenoid Drill 5mmBfArM
mdprc 048 09 18 000Zimmer Biomet, Inc.Vitality Shear-off Set ScrewBfArM
mdprc 047 09 18 000Zimmer IncAffixus Hip Fracture NailsBfArM
mdprc 042 09 18 000aap Implantate AG.Osteosynthesis, trauma implant, Drill CS 2.7/3.5, ø2.7, L 130, quick coupling, sterileBfArM
mdprc 041 09 18 000CareNow Medical Pvt LtdECO BATH WIPES with 2% w/v Chlorhexidine Gluconate SolutionBfArM
mdprc 040 09 18 000Carl Zeiss Meditec Inc611P CT Lucia Intraocular Lenses | +11.5 DBfArM
mdprc 039 09 18 000Edwards LifesciencesCardioband Mitral Reconstruction System IFUBfArM
mdprc 038 09 18 000Lowenstein Medical GmbH &Co.KGpower supply units for the sleep therapy devicesBfArM
mdprc 037 09 18 000MedcompVarious Short-Term Hemodialysis ProductsBfArM
mdprc 036 09 18 000MieleCX1020, CX2020, PS5xxx sterilisersBfArM
mdprc 035 09 18 000Mobius Imaging, LLCAIRO Mobile CT Scanner (model # MobiCT-32)BfArM
mdprc 034 09 18 000SLK Medical GmbHSLK Varilymph 12 ProBfArM
mdprc 033 09 18 000TransMedicsOrgan Care System (OCS) Heart Console, OCS Lung Console, OCS Liver ConsoleBfArM
mdprc 032 09 18 000Zimmer Biomet, Inc.HipLOC System Plate BarrelBfArM
mdprc 031 09 18 000Zimmer Biomet, Inc.Zimmer Natural Nail System Tibial Nail – Yellow 8.3 mmBfArM
mdprc 023 09 18 000iMDsoft LtdMetaVision Suite, Clinical Information SystemBfArM
mdprc 085 06 18 001SIEMENSAXIOM Aristos MX/VXhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166243
mdprc 071 08 18 000Samsung ElectronicsSamsung X-ray systems BfArM
mdprc 070 08 18 000HUM GmbHAEROtube-ET01-65M-SET, Endotrachealtubus-SET,mit Manschette, einzeln steril verpacktBfArM
mdprc 069 08 18 000Groupe LepineTRENDHIP STANDARD CEM.LESS 12/14 SIZE 2BfArM
mdprc 068 08 18 000FENDO Medizinztechnik e.K.Zytologiebürste EinwegBfArM
mdprc 066 08 18 000Bausch & Lomb GmbH..Stellaris Elite™ Single Port Vitrectomy Cutters in GaugeBfArM
mdprc 065 08 18 000Alcon Laboratories Inc.Alcon LuxOR E71 and E71 Q-Vue Ophthalmic MicroscopeBfArM
mdprc 035 08 18 000aap Implantate AGSterile cannulated screws, Cannulated Screw 7.5BfArM
mdprc 034 08 18 000AesculapEnnovate Rod PersuaderBfArM
mdprc 033 08 18 000Dr. Mach GmbH & Co. KGAll lighting systemsBfArM
mdprc 032 08 18 000Genesis Biosystems IncLipiVage systemBfArM
mdprc 031 08 18 000Reckitt Benckiser HealthcareDUREX Love Collection, DUREX Natural Feeling and DUREX Natural Feeling Easy GlideBfArM
mdprc 030 08 18 000Scholly Fiberoptic GMBHUretero-Renoscope, NephroscopeBfArM
mdprc 029 08 18 000sellution medical GmbHPessary – Panpac Medical CorporationBfArM
mdprc 028 08 18 000SIEMENSARTIS Q and ARTIS Pheno SystemsBfArM
mdprc 007 08 18 000CepheidXpert C.Difficile BT assayBfArM
mdprc 006 08 18 000Diagnostica StagoSTA Néoplastine CI 10 and CI Plus 10BfArM
mdprc 005 08 18 000Hamamatsu CorporationNanoZoomer S360BfArM
mdprc 004 08 18 000Mikrogen GmbHrecomWell Borrelia lgMBfArM
mdprc 003 08 18 000QIAGEN LtdEZ1 Advanced XLBfArM
mdprc 002 08 18 000The Binding SiteNK012.S - Human lgM Kit for use on SPAPLUSBfArM
mdprc 148 07 18 000Surgiris S.A.S.LEDVISION, surgical lightsBfArM
mdprc 147 07 18 000ConMed CorporationHall Small Lithium Battery L3000SMBfArM
mdprc 146 07 18 000Demophorius LtdDemotek Solution Administration IV SetBfArM
mdprc 145 07 18 000Frei AG Aktive RehaGYM and GYM X treatment tablesBfArM
mdprc 144 07 18 000Medica Medizintechnik GmbHTHERA-Trainer balo / THERA-Trainer vertoBfArM
mdprc 143 07 18 000Medline Industries Inc«Applimed» cannula needle straight with olive, 100mm, stainless steel, G18, diameter 1.19mm, included in Medline Sterile Procedure TraysBfArM
mdprc 142 07 18 000Weinmann.MEDUMAT Transport VentilatorsBfArM
mdprc 141 07 18 000Weinmann.MEDUCORE Standard 2BfArM
mdprc 114 07 18 000Cook Inc,Chorion Villus Biopsy Needle SetBfArM
mdprc 113 07 18 000Dako Denmark A/SMonoclonal Mouse Anti-Human MSH2 FE11BfArM
mdprc 112 07 18 000Heraeus Medical GmbHCOPAL knee moulds size LBfArM
mdprc 111 07 18 000Leica Microsystems, Inc.DS9800 Bond Polymer Refine DetectionBfArM
mdprc 110 07 18 000Meditrade GmbHBeeSana Mullkompresse; 5x5 cm, 8-fachBfArM
mdprc 109 07 18 000NordicNeuroLab ASPower supply (LPS) for LCD monitor (Version 1.0 and 1.1)BfArM
mdprc 108 07 18 000P J Dahlhausen & CoTrocar catheterBfArM
mdprc 107 07 18 000Smith & Nephew incJELONET 15CM X 2M CTN 12 (JOAR)BfArM
mdprc 106 07 18 000Zimmer Biomet, Inc.Persona Partial Knee System Spacer Block Alignment TowerBfArM
mdprc 083 07 18 000Ion Beam Applications S.A.Proteus 235, ProteusPLUSBfArM
mdprc 082 07 18 000Pro Med Instruments GmbHDORO LUCENT Base Unit, Locking Transitional Member, Transitional MemberBfArM
mdprc 081 07 18 000Smith & Nephew incVISIONAIRE LIGHTWEIGHT ALIGNMENT RODBfArM
mdprc 080 07 18 000Xion GmbhHXION Endoscopy Systems with Windows 10 Pro / LTSBBfArM
mdprc 076 07 18 000BD BiosciencesBD FACS Universal LoaderBfArM
mdprc 075 07 18 000Frei AG Aktive RehaFREI AG portable and height adjustable training tableBfArM
mdprc 066 07 18 000Biotype Diagnostik GmbHIVDD Mentype MycoDerm Lateral Flow KitsBfArM
mdprc 065 07 18 000Cardinal HealthHydroline and Pulse Wave ProductsBfArM
mdprc 064 07 18 000concile GmbHInfectCheck NeoPTBfArM
mdprc 063 07 18 000DIALAB GmbHCK-MB, opt. DGKC / IFCC; GLDH, DGKCBfArM
mdprc 052 02 18 001Geratherm Medical AGUnitque Temp° Pflege Set 1BfArM
mdprc 062 07 18 000OHST Medizintechnik AGMüller Straight Stem size 6.25 LateralBfArM
mdprc 061 07 18 000Smith & Nephew incRT-PLUS MOD FEMORAL COMPONENT RIGHT 4RBfArM
mdprc 060 07 18 000Smiths Medical ASD IncCoro-Set Bonn Marien-Krankenhaus Custom Kits (5/bx)BfArM
mdprc 048 07 18 000BEKA Hospitec GmbHCARLO Patient LiftBfArM
mdprc 047 07 18 000Frei AG Aktive RehaTHERA treatment tables BfArM
mdprc 046 07 18 000Heraeus Medical GmbHPALACOS and COPAL bone cementsBfArM
mdprc 045 07 18 000Lohmann und Rauscher GmbH & Co. KGRaucodrape camera drape 16x250 in set KitpackBfArM
mdprc 044 07 18 000Teleflex MedicalHydraulic Ureter DilatorsBfArM
mdprc 017 07 18 000DePuy International LimitedCORAIL Cementless Femoral Stem HA Coated StandardBfArM
mdprc 016 07 18 000GE Medical Systemsverschiedene MRT-SystemeBfArM
mdprc 015 07 18 000Intuitive Surgical Incda Vinci Surgical SystemBfArM
mdprc 014 07 18 000Servona GmbHSERVOX SilberkanüleBfArM
mdprc 013 07 18 000Smith & Nephew incLEGION HK TIBIAL BASE S. 5 LEFTBfArM
mdprc 012 07 18 000Stryker CommunicationsAnkle Arthrodesis Nail / Proximal Humeral NailBfArM
mdprc 038 05 18 001SIEMENSArtis zee/Q/Q.zen systems with Large Display DSC 5608-DCBfArM, FDA https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165058
mdprc 090 06 18 000Fritz Stephan GmbHSOPHIEBfArM
mdprc 089 06 18 000Hase BikesTrigo SportBfArM
mdprc 088 06 18 000Integra LifeSciences ORTHOPAEDICADVANSYS MLP/DLP, ADVANSYS TTC, TIBIAXYS, and UNI-CP Plates and TIBIAXYS and Large QWIX Cortical ScrewsBfArM
mdprc 087 06 18 000LDN Labordiagnostika Nord GmbH & Co.KG2-MET Urine ELISA Fast TrackBfArM
mdprc 086 06 18 000O-Two Medical Technologies, IncEquinox Relieve and Equinox Relieve II N2O/O2 Analgesic Gas Mixing and Delivery SystemsBfArM
mdprc 084 06 18 000Zimmer Biomet, Inc.Vanguard Complete Knee System.BfArM
mdprc 090 03 17 001PENTAX Europe GmbHPENTAX Medical ED-3490TK Duodenoscope and inspection of all PENTAX DuodenscopesBfArM
mdprc 081 06 18 000Cook Medical Europe LimitedCirrus-14 Wire Guide AQ Hydrophilic CoatingBfArM
mdprc 080 06 18 000Getinge Disinfection ABGetinge WD15 Claro, Model GE15BfArM
mdprc 079 06 18 000OlympusKeyMed Endosonic CleanerBfArM
mdprc 078 06 18 000OssurHalo skull pins BfArM
mdprc 077 06 18 000Schwarzer Cardiotek GmbHECG-Splitter (accessory Schwarzer Evo)BfArM
mdprc 076 06 18 000SIEMENSsyngo.via VB30ABfArM
mdprc 075 06 18 000Thermo Fisher Scientific Inc.Thermo Scientific Oxoid BIGGY Agar 500g CM0589BBfArM
mdprc 074 06 18 000Vermeiren N.V.QuavaBfArM
mdprc 045 06 18 000William Cook Europe ApSZenith Branch Iliac Endovascular Graft (ZBIS) - Patient CardBfArM
mdprc 044 06 18 000Mikrogen GmbHrecomLine ANA/ENA IgGBfArM
mdprc 043 06 18 000Medtronic SAActiva PC+S Implantable Neurostimulator (INS)BfArM
mdprc 042 06 18 000Medline Industries Inc….Medline SPT PacksBfArM
mdprc 041 06 18 000LABOR + TECHNIK Eberhard Lehmann GmbHLT-SYS, Based on NAD(H) and/or NADP(H) ReactionsBfArM
mdprc 040 06 18 000Johnson & Johnson Vision CareCatalys Precision Laser System..BfArM
mdprc 039 06 18 000Frei AG Aktive RehaARCUS treatment tablesBfArM
mdprc 038 06 18 000Biocare Medical LlcVulcan Fast Red Chromogen KitBfArM
mdprc 037 06 18 000Data InnovationsInstrument Manager Software.BfArM
mdprc 018 06 18 000Implant Direct Sybron Manufacturing,LLCLegacy Implant Closed-Tray Transfer-Concave Profile 3.5mmD PlatformBfArM
mdprc 017 06 18 000Implant Direct Sybron Manufacturing,LLCReplant 5.0mmD Abutment Assy 15 deg AngledBfArM
mdprc 016 06 18 000SIEMENSARTIS phenoBfArM
mdprc 015 06 18 000WASSENBURG Medical B.VWASSENBURG WD440, WD440 PT, WD415 Endoscope WasherDisinfector.BfArM
mdprc 014 06 18 000RTI Surgical, Inc ,CopiOs Cancellous Particulate XenograftsBfArM
mdprc 013 06 18 000Natus Medical Inc.EMU40/EMU40EX Breakout BoxesBfArM
mdprc 012 06 18 000MAQUET IncEmergency Room Examination TableBfArM
mdprc 011 06 18 000Elekta IncMonaco RTP System. .BfArM
mdprc 010 06 18 000Balt Extrusion.FARGO Guiding catheterBfArM
mdprc 132 05 18 000Coherex Medical Inc.Coherex WaveCrest Left Atrial Appendage Occlusion SystemBfArM
mdprc 131 05 18 000Dako Denmark A/SMonoclonal Mouse AntiHuman Cytokeratin, High Molecular Weight, Clone 34βE12BfArM
mdprc 130 05 18 000MTW-EndoskopieSingle Use Biopsy Forceps, oval spoonshaped mouth, fenestrated,BfArM
mdprc 129 05 18 000PARIPARI NaCl Inhalation Solution (NaCl 0,9 %, lot 052C)BfArM
mdprc 128 05 18 000Stryker Leibinger GmbH & Co.KGQuickFlap, Neuro ImplantsBfArM
mdprc 127 05 18 000Thermo Fisher Scientific Inc.Oxoid Brilliance MRSA 2 / Brilliance Staph24BfArM
mdprc 109 05 18 000Alpha- Bio Tec. Ltd.Milling Drill D1.5mm BfArM
mdprc 108 05 18 000Arrow International IncARROW Multiple-Lumen Central Venous CatheterBfArM
mdprc 107 05 18 000Elekta IncHexaPOD evo RT SystemBfArM
mdprc 106 05 18 000Kimal Plc.Procedure packs containing specific introducers (with and without guidewires), peelaway sheaths and peelaway dilators.BfArM
mdprc 105 05 18 000Smiths Medical ASD Inc..Infusion Stopcock Blister Pack IntegrityBfArM
mdprc 104 05 18 000Ulrich GmbH & Co. KGTraction cables for our ulrich medical traction cable winch retractorsBfArM
mdprc 103 05 18 000Zimmer Biomet, Inc.GTS Rasp Size +7 / GTS OHST Rasp Size +7BfArM
mdprc 102 05 18 000Zimmer Biomet, Inc.Werber Countersink Cannulated for micro CBS screwsBfArM
mdprc 009 04 17 001Intuitive Surgical IncDa Vinci® Xi EndoWrist Stapler Release KitBfArM, NCMDR
mdprc 083 05 18 000StrykerFarabeuf Clamp for 3.5mm Screws PROBfArM
mdprc 070 05 18 000DENTSPLY InternationalCEREC AC / AF / AI with OmnicamBfArM
mdprc 069 05 18 000DiaSys Diagnostic Systems GmbH.CRP IS / Super ID CRP; TruLab CRP / Nobicon CRP byBfArM
mdprc 068 05 18 000Mattes Instrumente GmbH MedizinTechnikReprocessable surgical instrumentsBfArM
mdprc 067 05 18 000OlympusOlympus EVIS DUODENOVIDEOSCOPE PJF-240BfArM
mdprc 066 05 18 000Visaris d.o.o.Vision CBfArM
mdprc 046 05 18 000Cardinal Health..Yankauer Suction Tubing, Penrose Tubing, Trocar Catheter, Thoracic CatheterBfArM
mdprc 045 05 18 000AesDex, LLCCardica C-Port xA & Flex-A PLUS AnastomosisBfArM
mdprc 044 05 18 000CYTOCELL LTDcMYC (MYC) Breakapart BfArM
mdprc 043 05 18 000MAQUET IncAll Arterial Cannulae and Customized Tubing Packs including the 3/8” Vent plugBfArM
mdprc 042 05 18 000Lsi Medience CorporationPATHFAST CKMB, Myoglobin and NTproBNP BfArM
mdprc 041 05 18 000Macopharma SASEasyflex PVC empty bagsBfArM
mdprc 040 05 18 000Medtronic SALYNDA + Amplya Acute Multitherapeutic System and CPFA Coupled Plasma Filtration Adsorption therapyBfArM
mdprc 039 05 18 000SIEMENSARTIS pheno systems..BfArM
mdprc 049 02 18 001SIEMENSSOMATOM verschiedene Typen mit Somaris 5BfArM, FDA
mdprc 009 05 18 000Amplitude GmbHSHERIC bipolar cup- Size 56/28BfArM
mdprc 008 05 18 000Apollo Endosurgery Inc.BIB/Orbera/Orbera365 Intragastric Balloon SystemsBfArM
mdprc 007 05 18 000GE HealthcareMR Surgical Suite Table Transfer ReleaseBfArM
mdprc 006 05 18 000K2M Inc.Cascadia Interbody SystemBfArM
mdprc 005 05 18 000New Oncology GmbHNEOselect/NEOliquid - POST PCR Box (-20°C storage)BfArM
mdprc 004 05 18 000Schuchmann GmbH & Co. KGMalte, Malte-Outdoor, MarcyBfArM
mdprc 003 05 18 000Torax MedicalLinx Reflux Management SystemBfArM
mdprc 002 05 18 000Vital Healthcare Sdn.Bhd.NovaLine / Tubing Sets for HemodialysisBfArM
mdprc 001 05 18 000Zimmer Biomet, Inc.Gentle Threads Interference ScrewBfArM
mdprc 143 04 18 000Asid Bonz GmbHOxygen Mask for Adults and Children, high concentrationBfArM
mdprc 142 04 18 000CUTTING EDGE SASSYNTHESIS BfArM
mdprc 141 04 18 000Immucor GmbHMATCH IT! DNA software BfArM
mdprc 140 04 18 000Scaffdex OyRegJointBfArM
mdprc 139 04 18 000Smith & Nephew incLEGION CR HIGH FLEX XLPEBfArM
mdprc 121 04 18 000B. Braun MelsungenSeQuent Please OTWBfArM
mdprc 120 04 18 000IBL International GmbHVitamin D kit, 25-hydroxyvitamin D3BfArM
mdprc 119 04 18 000LAP GmbH Laser ApplikationenAPOLLOblue (24V)BfArM
mdprc 118 04 18 000Nihon Kohden Corp.Hematology Analyzer MEK-9100 Celltac GBfArM
mdprc 117 04 18 000Smiths Medical ASD IncPortex Thoracic Catheter and Connecting TubeBfArM
mdprc 116 04 18 000Cook Medical Europe LimitedSoft-Trans Embryo Transfer CatheterBfArM
mdprc 115 04 18 000Geratherm Medical AGGeratherm UniqueResc+BfArM
mdprc 114 04 18 000IBL International GmbHProgesterone Saliva Luminescence ImmunoassayBfArM
mdprc 113 04 18 000Ranfac Corp.Blue Suture GrasperBfArM
mdprc 112 04 18 000RaySearch Laboratories ABRayStation 6 (RayPlan 2) and RayStation 7 (RayPlan 7)BfArM
mdprc 111 04 18 000Siemens Healthcare Diagnostics GmbHSample Diluents used with Dimension Vista SystemsBfArM
mdprc 110 04 18 000Thermo Fisher Scientific OyOxoid CT1412B CPO30 CefpiromeBfArM
mdprc 109 04 18 000Thermo Fisher Scientific OyOxoid Columbia CNA Aesculin Selective Agar / MacConkey Agar No. 3 (mod.)BfArM
mdprc 054 03 18 001Keystone Dental IncStage-1 Tissue Punch, Disposable, 4.5mmBfArM, FDA https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162775
mdprc 061 04 18 000Becton Dickinson & Co. (BD)BD Vacutainer Citrate Plus Blood Collection TubesBfArM
mdprc 060 04 18 000BD Diagnostic SystemsVIASURE Flu A, Flu B and RSV Real Time PCR Detection Kit to be used by BD MAXBfArM
mdprc 059 04 18 000FEG Textiltechnik Forschungs-und Entwicklungsgesellschaft mbHDynaMesh PR2 soft 2B , DynaMesh PR4 soft 2BBfArM
mdprc 058 04 18 000First Global Enterprises LimitedOxygen Mask for adult, high concentration, non‐rebreather/AsidBonzBfArM
mdprc 057 04 18 000Implant Direct Sybron Manufacturing,LLCInterActive Healing CollarBfArM
mdprc 056 04 18 000ImplantcastMUTARS HD Coupling C-O-MBfArM
mdprc 055 04 18 000Siemens Healthcare Diagnostics ProductSyva Emit II Plus 6-Acetylmorphine assayBfArM
mdprc 054 04 18 000Venner MedicalVenner PneuX P.Y Endotracheal tube (Non-MRI)BfArM
mdprc 053 04 18 000Wright Medical Technology ,IncValor NailBfArM
mdprc 029 04 18 000DiaSys Diagnostic Systems GmbH.oneHbA1c FSBfArM
mdprc 009 01 18 001GE HealthcareMonica IF24 Interface SystemsBfArM, FDA https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162388
mdprc 018 04 18 000bioMerieux IncVIKIA Malaria Ag Pf/PanBfArM
mdprc 017 04 18 000Cook IncStoneBreaker Pneumatic LithotripterBfArM
mdprc 016 04 18 000Dako Denmark A/SMonoclonal Mouse, Anti-Pneumocystis J. & Anti HumanBfArM
mdprc 015 04 18 000invicon diagnostic concepts GmbHHbA1c HIT917BfArM
mdprc 014 04 18 000Kimal Plc.Multi-lumen Altius Central Venous Catheter kitBfArM
mdprc 013 04 18 000Bellco CanadaMICROPLAS plasmafiltersBfArM
mdprc 012 04 18 000Radiometer America IncTCM modules: TCM4 Combi, TCM CombiM and TCM ToscaBfArM
mdprc 011 04 18 000SIEMENSSOMATOM GO.UP and SOMATOM go.NowBfArM
mdprc 010 04 18 000Synthes IncFLEX ARM INSTRUMENTBfArM
mdprc 009 04 18 000Synthes IncEpoca Stem Extractors and Connection ScrewsBfArM
mdprc 109 11 17 001Stryker InstrumentsAutoplex and Hivac Cement InjectBfArM
mdprc 126 10 14 001Terumo Cardiovascular Systems CorporationTerumo Advanced Perfusion System 1 - Heart-Lung Machine.BfArM , NCMRD
mdprc 135 03 18 000Zimmer incREVITAN prox. spout 75 BfArM
mdprc 134 03 18 000Zimmer Biomet, Inc.Charcot Osteotome Chisel (Trauma & Foot and Ankle instruments) BfArM
mdprc 133 03 18 000Woson Medical Instrument Co., Ltd.TANZO TOUCH TT+23 BfArM
mdprc 132 03 18 000Troge Medical GmbHTRO-DONORSET BfArM
mdprc 131 03 18 000ThermoFisher ScientificThermo Scientific Oxoid Mueller-Hinton Broth.BfArM
mdprc 130 03 18 000Silony MedicalTorque Limiter 10Nm, Org. BfArM
mdprc 129 03 18 000Nobel Biocare Services AB17° Multi-Unit Abutment Conical Connection NP 2.5mm BfArM
mdprc 128 03 18 000Molnlycke Health Care AB.Mölnlycke Procedure trays, Cannula Needle, 100mm, 18G BfArM
mdprc 127 03 18 000Miltenyi Biotec GmbHLIFE 18 - Theraline pro Tubing set BfArM
mdprc 126 03 18 000MAQUET IncOTESUS OR tableBfArM
mdprc 125 03 18 000Getinge Disinfection ABGETINGE Aperlan Poka-Yoke Agent A BfArM
mdprc 088 03 18 000AesculapHandles THA (Total Hip Arthroplasty)BfArM
mdprc 087 03 18 000BIOTRONIK UK LtdPulsar-18, Peripheral self-expanding Nitinol stent systemBfArM
mdprc 086 03 18 000CryoLife, Inc.ON-X Prosthetic Heart Valve ONXABfArM
mdprc 085 03 18 000DiaSys Diagnostic Systems GmbH.HbA1c FS/ one HbA1c ISBfArM
mdprc 084 03 18 000FUJIFILM CorporationVP-7000 Video Processor SystemsBfArM
mdprc 083 03 18 000Invacare CorporationDLX‐PM75AL‐B LiNX Power Modules (used for Bora and Kite PWCs)BfArM
mdprc 082 03 18 000Medtronic SADxTerity Diagnostic CatheterBfArM
mdprc 081 03 18 000SIEMENSACUSON SC2000 ultrasound systemBfArM
mdprc 080 03 18 000The Binding SiteLK043.L.OPT(.A) - Optilite Beta-2-microglobulin Urine KitBfArM
mdprc 079 03 18 000Tracoe medical GmbHTRAGOE comfort Tracheostomy TubeBfArM
mdprc 120 02 18 001Ivy Sports MedicineCMI - Collagen Meniscus Implanthttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=161212
mdprc 121 12 17 001Pacific Medico Co., LtdPMH7000 series Heated humidifiersBfArM
mdprc 055 03 18 000Chalice Medical LtdParagon OxygenatorBfArM
mdprc 053 03 18 000Siemens healthcare diagnostics products gmbhAtellica SolutionBfArM
mdprc 052 03 18 000SoluscopeEndoscope washer-disinfector Soluscope Serie 4 PABfArM
mdprc 051 03 18 000Waldemar LINK GmbH & CoAlignment guide 55° of TOP II Impactor HandleBfArM
mdprc 050 03 18 000Zimmer BiometAvenir Muller Stem (Hip implant)BfArM
mdprc 043 03 18 000Abbott Laboratories IncARCHITECT c4000 / c8000 / c16000 cuvette segmentsBfArM
mdprc 038 03 18 000DePuy International LtdCORAIL Cementless Femoral Stem HA coated, 12/14 AMT, 135°, Standard, No Collar, Size 12BfArM
mdprc 037 03 18 000Herco Wassertechnik GmbHHP xxx D/x/x mit Hercotherm RingBfArM
mdprc 036 03 18 000MedcompMultiple Medical Devices of Hemodialysis catheter and accessoriesBfArM
mdprc 035 03 18 000Miltenyi Biotec GmbHTubing Set TPE LIFE 18BfArM
mdprc 034 03 18 000Zimmer BiometAIM Tibial NailBfArM
mdprc 033 03 18 000Zimmer BiometINNEX TIB INSERT FIXUC L112.5 and Modular BipolarBfArM
mdprc 018 03 18 000Immucor GmbH.MATCH IT! DNA softwareBfArM
mdprc 136 02 18 000Canon IncRadrex-i (Canon)BfArM
mdprc 135 02 18 000Hamilton Medical IncHAMILTON-C1/ -C2/ -C3/ -C6 Ventilator unitBfArM
mdprc 134 02 18 000Implant Direct Sybron Manufacturing,LLCLegacy1 SBM ImplantBfArM
mdprc 133 02 18 000Medtronic SABarrx 360 Express RFA Balloon CathetersBfArM
mdprc 132 02 18 000Micromed SpACar Pole CartsBfArM
mdprc 131 02 18 000Roche Diagnostics CorpCobas b221BfArM
mdprc 122 02 18 000Beckman CoulterMicroScan LabPro Information Manager SystemBfArM
mdprc 121 02 18 000GCMedica Enterprise LtdUterine Aspiration TubeBfArM
mdprc 119 02 18 000Medical Econet GmbHCardio M plusBfArM
mdprc 118 02 18 000Philips BurtonPhilips ear thermometerBfArM
mdprc 114 02 18 000GenePOC IncrevogeneBfArM
mdprc 113 02 18 000Micropoint BiotechnologiesqLabs PT-INR Monitoring SystemBfArM
mdprc 112 02 18 000Osatu, S. Coop.REANIBEX 300y,REANIBEX 500BfArM
mdprc 111 02 18 000Roche Diagnostics GmbHVENTANA anti-ALKBfArM
mdprc 110 02 18 000Siemens Healthcare Diagnostics GmbHDimension Vista Calcium Flex reagent cartridgeBfArM
mdprc 109 02 18 000Vygon UK LtdVYLIFE, KIT VYLIFEBfArM
mdprc 079 02 18 000HEINE Optotechnik GmbH & Co. KGHEINE Standard F.O. Laryngoskopgriff mit LED-BeleuchtungBfArM
mdprc 078 02 18 000Shippert Medical Technologies IncTissu-TransBfArM
mdprc 067 02 18 000Beckman CoulterAQUIOS CL Flow Cytometer System.BfArM
mdprc 066 02 18 000Brainlab AGExacTrac Patient Positioning SystemBfArM
mdprc 065 02 18 000Getinge Disinfection ABGetinge 86- and 88-seriesBfArM
mdprc 064 02 18 000Hitachi Medical CorpOASISBfArM
mdprc 063 02 18 000Medicrea InternationalIMPIX MANTA preloaded on holderBfArM
mdprc 062 02 18 000RaySearch Laboratories ABRayStation 4.9 (RayPlan 1),BfArM
mdprc 061 02 18 000Stryker OrthopaedicsTriathlon Knee System 5mm & 10mm Tibial AugmentBfArM
mdprc 051 02 18 000IBL International GmbHCortisol Saliva ELISABfArM
mdprc 050 02 18 000MAKO Surgical CorpAKO RIO Spare Part Ethernet-Fiber Optic ConverterBfArM
mdprc 047 02 18 000TRILUX Medical GmbH & Co. KGAurinio LED OP LeuchteBfArM
mdprc 021 02 18 000bioMerieux IncETEST Polymyxin B (PO1024)BfArM
mdprc 020 02 18 000Carl Zeiss Meditec Inc611P CT LUCIA Posterior Chamber Hydrophobic Acrylic LensBfArM
mdprc 019 02 18 000Ion Beam Applications S.A.Proleus 235, ProleusPLUSBfArM
mdprc 018 02 18 000IRRAS AB Inc.IRRAflow Control Unit ICCU 020BfArM
mdprc 017 02 18 000Medline Industries IncMedline Fluid Management – MED-SOFT 3-liter suction linersBfArM
mdprc 016 02 18 000Medtronic SAO-Arm 1000 Surgical Imaging SystemsBfArM
mdprc 015 02 18 000Miltenyi Biotec GmbHCD34/CD133 Enumeration Kit, human (IVD) BfArM
mdprc 012 02 18 000Phadia LtdEliA anti-TSH-R WellBfArM
mdprc 011 02 18 000Stryker OrthopaedicsMako Onlay Insert ExtractorBfArM
mdprc 102 01 18 000BioVentrix, Inc.Revivent TC Ventricular Enhancement SystemBfArM
mdprc 101 01 18 000Edwards LifesciencesAnchor Drive for Cardioband SystemBfArM
mdprc 100 01 18 000GI Dynamics IncGi Dynamics EndoBarrier Gastrointestinal Liner with Delivery SystemBfArM
mdprc 099 01 18 000IBL International GmbHCortisol Saliva Luminescence ImmunoassayBfArM
mdprc 098 01 18 000Samsung Electronics Co., Ltd.LABGEO HC10BfArM
mdprc 082 01 18 001Gambro Lundia ABMARS Kit GambroBfArM
mdprc 004 01 18 001Smith & Nephew incTAYLOR SPATIAL FRAME WEBSITE SOFTWAREBfArM
mdprc 081 01 18 000Smiths Medical ASD Inc.Medfusion 3500 and 4000 Syringe Infusion PumpsBfArM
mdprc 080 01 18 000Tornier IncSalto Talaris Tibial ComponentsBfArM
mdprc 067 01 18 000DiaSys Diagnostic Systems GmbH.reagent 2 in oneHbA1c FSBfArM
mdprc 066 01 18 000Medix BiochemicaActim RSVBfArM
mdprc 065 01 18 000Smith & Nephew incR3 0 Hole Acetabular Shell 50mm and R3 Constrained Acetabular Liner 52mmBfArM
mdprc 064 01 18 000The Binding SiteRheumatoid Factor Kit for use on SPAPLUSBfArM
mdprc 063 01 18 000Zimmer IncACE Trochanteric Nail System ProductsBfArM
mdprc 042 01 18 000Humantech Germany GmbHTRISTANflex - Anterior Cervical Interbody FusionBfArM
mdprc 041 01 18 000Siemens Healthcare Diagnostics GmbHADVIA Centaur CP, XP, and XPT Systems BfArM
mdprc 040 01 18 000SIEMENSAXIOM ArtisBfArM
mdprc 029 01 18 000Gebrueder Martin GmbH & Co KGLaser Safety GlassesBfArM
mdprc 028 01 18 000Intersurgical LimitedBVM (Bag-Valve-Mask) Manual Resuscitation SystemsBfArM
mdprc 027 01 18 000Merit Medical Systems IncPrelude SNAP Splittable Sheath IntroducersBfArM
mdprc 026 01 18 000Nobel BiocareIPS CaseDesignerBfArM
mdprc 025 01 18 000SIEMENSsyngo Workflow MLR..BfArM
mdprc 024 01 18 000Siemens Healthcare Diagnostics IncAtellica UAS 800 analyzer.BfArM
mdprc 023 01 18 000Spiegelberg GmbH & Co KGExternal Ventricular Drainage Kits 08923/17
mdprc 022 01 18 000Stryker NeurovascularGuider Softip XF Guide CathetersBfArM
mdprc 021 01 18 000Teleflex MedicalSafetyCat PLUS / B.Braun wit SyringeBfArM
mdprc 020 01 18 000Udo Heisig GmbHSpangenbezug C-SET, PEBfArM
mdprc 011 01 18 000CepheidXpert GBSBfArM
mdprc 010 01 18 000AesculapIQ E.MOTION PS PRO SLEEVE F/BOX CUTTER MBfArM
mdprc 008 01 18 000Halyard Health Co.CORTRAK 2 Nasogastric/Nasointestinal Feeding Tube with Electromagnetic Transmitting Stylet with ANTI-IV ConnectorBfArM
mdprc 007 01 18 000Merit Medical Systems IncCF-5242 – Peritoneal Dialysis CatheterBfArM
mdprc 006 01 18 000Radiometer America IncPICO70 Arterial Blood SamplerBfArM
mdprc 005 01 18 000SIEMENSSOMATOM GO.UP and SOMATOM go.Now.BfArM
mdprc 003 01 18 000ThermoFisher.ImmunoCAP Allergen c5, ImmunoCAP Allergen c6BfArM
mdprc 125 12 17 000B. Braun Melsungen AGVasco-OP Sensitive Gr.7 Sterile – Surgical GlovesBfArM
mdprc 124 12 17 000bioMerieux IncVITEK 2 Antimicrobial Susceptibility Test Kit (AST)BfArM
mdprc 123 12 17 000Gambro Lundia ABGambro BL105 und Gambro BL208BDBfArM
mdprc 122 12 17 000Integra LifeSciencesIntegra Cadence Total Ankle System- Case for Trials, Insertion and Removal instruments (Insert Instrument Set)BfArM
mdprc 120 12 17 000Shanghai International Holding Corp. GmbH (Europe)Portable Dental Unit DU893BfArM
mdprc 077 12 17 000F. & M. Lautenschläger GmbH & Co. KGSteam Sterilizer ProtoCERTBfArM
mdprc 076 12 17 000Medtronic SAKYPHON Express Directional Bone FillerBfArM
mdprc 075 12 17 000Siemens Medical SolutionsArtis systems in conjunction with the Artis tableBfArM
mdprc 074 12 17 000Trumpf Medical Systems, Inc.TruVidia Wireless ReceiverBfArM
mdprc 073 12 17 000Zimmer, INCPersona Partial Knee Spacer Blocks Size 8mm, 9mm, 10mm, 12mm, 14mmBfArM
mdprc 071 12 17 000Johnson & Johnson Medical GmbHGLOBAL UNITE Platform Shoulder SystemBfArM
mdprc 070 12 17 000Zimmer, INCTapered Screw-Vent MTXBfArM
mdprc 069 12 17 000Z-Systems AGNDm-40-10 Zirkolith lmplant with NDm-P14 PinBfArM
mdprc 044 12 17 000Ion Beam Applications S.A.ProteusPLUS, ProteusONEBfArM
mdprc 039 12 17 000B. Braun Melsungen AGPerfusor compact plusBfArM
mdprc 038 12 17 000CAMLOG Biotechnologies AGCONELOG SCREW-LINE Implant, Promote plus, CAMLOG SCREW-LINE Implant, Promote und . CAMLOG SCREW-LINE Implant, Promote plusBfArM
mdprc 037 12 17 000CareFusionVyntus BODY with Option DiffusionBfArM
mdprc 036 12 17 000IBA Dosimetry GmbHProteusPLUS, ProteusONEBfArM
mdprc 035 12 17 000ImplantcastPlate for MUTARS Proximal Femur RevisionBfArM
mdprc 034 12 17 000IRRAS AB Inc.Irraflow Tube SetBfArM
mdprc 033 12 17 000K2M Inc.Everest Spinal SystemBfArM
mdprc 032 12 17 000Kimal plcAdult Altius Central Venous Catheter Kit (K2CS / K2CV) - 18G Echogenic Introducer NeedleBfArM
mdprc 031 12 17 000Philips HealthcareSonalleve MR-HIFUBfArM
mdprc 030 12 17 000Waldemar LINK GmbH & CoMobileLink Acetabular Cup System X-LINKed InsertBfArM
mdprc 018 12 17 000BrainLABBrainlab Navigation System Spine & Trauma 3DBfArM
mdprc 017 12 17 000Cook Incman Pleural/Pneumopericardial Drainage SetBfArM
mdprc 016 12 17 000Hitachi Medical CorpMHI-TM2000 / Vero Linac SystemBfArM
mdprc 015 12 17 000Philips HealthcareCombiDiagnostBfArM
mdprc 014 12 17 000St. Jude Medical IncNanostim Leadless PacemakerBfArM
mdprc 013 12 17 000WASSENBURG Medical B.VWASSENBURG WD440, WD440 PT, WD415BfArM
mdprc 113 11 17 000Accuray IncTomoTherapy Treatment System.BfArM
mdprc 112 11 17 000Edwards LifesciencesCardioband Mitral Reconstruction SystemBfArM
mdprc 111 11 17 000HUMAN Gesellschaft für Biochemica und Diagnostica GmbHHumatex ASOBfArM
mdprc 110 11 17 000Siemens Healthcare DiagnosticsAtellica 1500 Automated Urine Sediment AnalyserBfArM
mdprc 108 11 17 000Teleflex MedicalRUSCH SENSOR 2 WAY SILICONE CATHETER, STERILEBfArM
mdprc 107 11 17 000Beckman CoulteriChem VELOCITY Chemistry StripsBfArM
mdprc 106 11 17 000DiaSys Diagnostic Systems GmbH.Antistreptolysin O FSBfArM
mdprc 105 11 17 000duomedLifeseal Surgical SealantBfArM
mdprc 104 11 17 000gabmedgabControl Spice TestBfArM
mdprc 103 11 17 000GE HealthcareMillennium VG, Discovery VH, VariCamBfArM
mdprc 102 11 17 000OCULUS Optik Geräte GmbHPentacam AXLBfArM
mdprc 101 11 17 000Teleflex MedicalRÜSCH PVC catheter Tiemann patternBfArM
mdprc 100 11 17 000VIROTECH Diagnostics GmbHMeasles IgM ELISABfArM
mdprc 096 10 17 001AbbottAlinity i Processing ModuleNCMDR
mdprc 085 11 17 000IMAGE Information Systems Europe GmbHiQ-X 2.2.0BfArM
mdprc 084 11 17 000EOVEEO-150 VentilatorBfArM
mdprc 047 11 17 000BREAS Medical AB A GE Healthcare CoBreas Vivo 60.BfArM
mdprc 046 11 17 000Johnson & Johnson Vision Care1-DAY ACUVUE MOIST Brand Contact LensesBfArM
mdprc 045 11 17 000Mint Medical GmbHmint LesionBfArM
mdprc 044 11 17 000OlympusSmall intestinal videoscope SIF-Y0019 and Single use Spiral tube ST-Y0008BfArM
mdprc 043 11 17 000Roche Diagnostics Corpcobas MRSA/SA Nucleic acid test for use on the cobas Liat SystemBfArM
mdprc 042 11 17 000SIEMENSSOMATOM Force, SOMATOM Definition AS, Edge, FlashBfArM
mdprc 041 11 17 000Siemens Healthcare DiagnosticsCLINITEK Novus to Atellica UAS 800 Rack HandlerBfArM
mdprc 026 11 17 000AesculapCOLUMBUS REV FEMUR SPACER DISTAL F5 15MMBfArM
mdprc 025 11 17 000Boston ScientificEluvia 150mm and Innova 180mm & 200mm Stent SystemsBfArM
mdprc 024 11 17 000BrainLABExacTrac VeroBfArM
mdprc 023 11 17 000Cook MedicalGastrostomy and Gastrojejeunostomy SetsBfArM
mdprc 022 11 17 000Epigenomics AGEpi proColon Plasma Quick KitBfArM
mdprc 021 11 17 000Leica Biosystems Newcastle LtdBond Aspirating Probe Cleaning SystemBfArM
mdprc 020 11 17 000Maxter CathetersNasogastric Feeding Tubes for neonates & pediatricBfArM
mdprc 019 11 17 000Siemens Healthcare Diagnostics GmbHDimension® and Dimension Vista® Assays Biotin InterferenceBfArM
mdprc 018 11 17 000Technogenetics s.r.l.ZENIT RA Scl-70 REF. 41418BfArM
mdprc 017 11 17 000Thermo Fisher Scientific Inc.Remel Vibrio cholerae Inaba Agglutinating Serum.BfArM
mdprc 081 05 17 001Sekisui Virotech GmbHsoftware Kapelan LabImage LABfArM
mdprc 016 11 17 000Zimmer Biomet2.5 mm GemLock Hex Driver, RHD2.5BfArM
mdprc 117 10 17 000Hamamatsu CorporationNanoZoomer-SQBfArM
mdprc 116 10 17 000Pega MedicalGap Endo-Exo Medullary Nail DriversBfArM
mdprc 115 10 17 000SBM SASComposite screw LIGAFIX 60 Diam.7 - L:25 mmBfArM
mdprc 114 10 17 000SIEMENSBC Thrombin ReagentBfArM
mdprc 113 10 17 000Smith & NephewINTERTAN 10S 10MM X 18CM 130DBfArM
mdprc 112 10 17 000Sooil DevelopmentDana Diabecare IISBfArM
mdprc 111 10 17 000Stryker OrthopaedicsTactys Distal Stems BfArM
mdprc 110 10 17 000Zimmer incNormed Foot Kelle S. SHOE S. 44 STERBfArM
mdprc 057 10 17 001W.L. Gore & Associates Inc.Conformable GORE TAG Thoracic Endoprosthesis DevicesBfArM
mdprc 095 10 17 000Balt Extrusion.double lumen catheters ECLIPSE2L and COPERNIC2LBfArM
mdprc 094 10 17 000Coloplast A/STesticular Implant (Kiwee®) and Vaginal StentBfArM
mdprc 093 10 17 000DiaSys Diagnostic Systems GmbH.oneHbA1c IS, Super ID HbA1c.BfArM
mdprc 092 10 17 000Hoffrichter GmbHLAVI 30 / LAVI 40BfArM
mdprc 091 10 17 000Sintea Plustek SrlDynlock Semi-rigid Stabilization SystemBfArM
mdprc 090 10 17 000Steris CorpV-PRO 60 Low Temperature Sterilization SystemBfArM
mdprc 089 10 17 000Elva BV / Tava SurgicalBlades, Bone Cutting and Bur, orthopaedic BfArM
mdprc 088 10 17 000WEFIS GmbHPhaco-Handstück BfArM
mdprc 077 10 17 000AbbottARCHITECT c4000; ARCHITECT c8000; ARCHITECT c16000BfArM
mdprc 076 10 17 000Dewimed Medizintechnik GmbHOrthodontic Skeletal Anchorage Screw ( O.S.A.S. Screws )BfArM
mdprc 075 10 17 000Medtronic IncFlexCath Advance Steerable Sheath BfArM
mdprc 074 10 17 000Tracoe medical GmbHTRACOE twist Tracheostomy Tube Size 06 BfArM
mdprc 064 10 17 000Beckman CoulterAQUIOS CL Flow Cytometery SystemsBfArM
mdprc 063 10 17 000C R Bard IncMagic3, HydroSil Gripper, and Personal Intermittent CathetersBfArM
mdprc 062 10 17 000ICU Medical, IncIntravenous administration tubing extensionBfArM
mdprc 061 10 17 000Integra LifeSciencesIntegra CUSA Clarity Footswitch packaged with CUSA Clarity Console (Ref C7000BfArM
mdprc 060 10 17 000OlympusGyrus ACMI Round Cutting Burr - Variable ExposureBfArM
mdprc 059 10 17 000Smith & Nephew incENTACT SEPTAL STAPLER 3-PACKBfArM
mdprc 058 10 17 000Vascutek LimitedAnacondaBfArM
mdprc 056 10 17 000Zimmer BiometVanguard CR Tibial BearingBfArM
mdprc 055 10 17 000Zimmer BiometPulsavac Plus SystemBfArM
mdprc 045 10 17 000Tosoh CorporationS. AIA-PACK PROG II and S. AIA-PACK PROG IIIBfArM
mdprc 043 10 17 000Draeger Medical Systems IncDual Hemo MCable pod used with the Infinity Acute Care System (IACS) Monitoring SolutionBfArM
mdprc 042 10 17 000North American RescueARS Decompression NeedleBfArM
mdprc 041 10 17 000Stryker OrthopaedicsMAKO PKA & THA software of RIO system (MAKO Robot)BfArM
mdprc 040 10 17 000ACCURA Medizintechnik GmbHInfusion Controller STAT 2BfArM
mdprc 039 10 17 000Christoph Miethke GmbH & Co. KGproSA Tool SetBfArM
mdprc 038 10 17 000DIAGNOSTICS BIOCHEM CANADA INC.Free Testosterone ELISA KitsBfArM
mdprc 037 10 17 000Eppendorf AGEppendorf Reference 2BfArM
mdprc 036 10 17 000FUJIFILM CorporationEndoscopic Ultrasonic ProbesBfArM
mdprc 035 10 17 000Phagenesis LtdPhagenyx Base Station Treatment CablesBfArM
mdprc 034 10 17 000Schiller AGMonitor / Defibrillator DEFIGARD Touch7BfArM
mdprc 033 10 17 000SD BIOSENSORMultiCare Analyzer/ Lumiratek CBfArM
mdprc 032 10 17 000SOMATEX Medical Technologies GmbHSAFE-CUTBfArM
mdprc 029 10 17 000Intersurgical22 mm Flextube Transport Breathing SystemsBfArM
mdprc 015 10 17 000MerivaaraKnee Chest DeviceBfArM
mdprc 088 09 17 000Smith & Nephew incMETA-TAN 10MM X 34CM LEFTBfArM
mdprc 087 09 17 000Smith & Nephew incMETA-TAN 10MM X 38CM RIGHTBfArM
mdprc 086 09 17 000Applied Medical ResourcesEA010, VOYANT ESG 1/BXBfArM
mdprc 085 09 17 000Bischoff & Bischoff Medizin- und Rehabilitationstechnik GmbHAlevo AluBfArM
mdprc 084 09 17 000DiaSys Diagnostic Systems GmbH.oneHbA1c IS, Super ID HbA1cBfArM
mdprc 083 09 17 000DiaSys Diagnostic Systems GmbH.UIBC FS 1 1921BfArM
mdprc 082 09 17 000Hain Lifescience GmbHCertain IVD Downstream Applications Tested Using GXT NA Extraction KitsBfArM
mdprc 081 09 17 000ORGENTECORG 248 Alegria anti-MCVBfArM
mdprc 080 09 17 000Ortho-Clinical DiagnosticsORTHO Vision & Vision Max AnalyzerBfArM
mdprc 079 09 17 000Randox Laboratories Ltd.Lipid Control - Level 3BfArM
mdprc 077 09 17 000The Binding SiteNK034.S - Human Alpha 1 Antitrypsin Kit for on the SPAPLUSBfArM
mdprc 076 09 17 000Thermo Fisher Scientific Inc.Remel Vibrio Cholerae Ogawa agglutinating serumBfArM
mdprc 075 09 17 000aap Implantate AGaap Drill Guide LOQTEQ VA with scale up to L 28, drill diam. 2.0, 0BfArM
mdprc 074 09 17 000Carl Zeiss Meditec IncZEISS INTRABEAM PRS 500BfArM
mdprc 073 09 17 000Intersurgical22 mm Flextube Transport Breathing SystemsBfArM
mdprc 072 09 17 000Lohmann & Rauscher InternationalMetalline Tracheo DressingsBfArM
mdprc 071 09 17 000SIEMENSRobot Imager, Gantry Imager.BfArM
mdprc 070 09 17 000StrykerM-1 Roll In System Ambulance Stretchers with Schnitzler German Safety HooksBfArM
mdprc 073 08 17 000ThermoFisher.Phadia AB ImmunoCAP Herring AllergensBfArM
mdprc 072 08 17 000Becton Dickinson & Co. (BD)BD MultiTEST CD3/CD8/CD45/CD4BfArM
mdprc 071 08 17 000B Braun Surgical SANovosyn Quick Undyed Sterile Absorbable Surgical SuturesBfArM
mdprc 070 08 17 000TerumoBCTFemoSeal Vascular Closure SystemBfArM
mdprc 069 08 17 000Leonhard Lang GmbHDefibrillation Electrode SKINTACT DF59N and DF59NCBfArM
mdprc 068 08 17 000Implant Direct Sybron Manufacturing,LLCtra-System/ Legacy Guided Surgery Handle KitBfArM
mdprc 067 08 17 000Civco Medical Instruments IncRigid Arm SupportBfArM
mdprc 051 08 17 000Zimmer, INCVersys Beaded Hip Stems and Segmental Knee ProductsBfArM
mdprc 050 08 17 000Toshiba Medical Systems CorporationRadrex-iBfArM
mdprc 049 08 17 000Shenzhen MindrayBeneFusion VP1, BeneFusion VP3 infusion pump BfArM
mdprc 048 08 17 000Roche Diagnostics CorpPreciControl UniversalBfArM
mdprc 047 08 17 000Richard Wolf GmbHArthroline Stanze B 4,6MM H1,6MMBfArM
mdprc 046 08 17 000AesculapVEGA PS TIBIA-PROBE-/PRÄPARIERPLAT.T4BfArM
mdprc 045 08 17 000AesculapCESPACE PEEK TRIAL IMPLANT 5° 16X12MM ANATBfArM
mdprc 043 08 17 000Christoph Miethke GmbH & Co. KGDualswitch Valve (DSV)BfArM
mdprc 042 08 17 000Litos GmbHZugschraubeBfArM
mdprc 104 07 17 000Angiomed GmbH & Co. Medizintechnik KG.Vivexx Carotid StentBfArM
mdprc 103 07 17 000DiaSys Diagnostic Systems GmbH.Creatinine PAP FSBfArM
mdprc 102 07 17 000Dr. Fooke-Achterrath Laboratorien GmbHTotal IgE-HRP EIABfArM
mdprc 101 07 17 000EtacFlex grab rail adhesive mountBfArM
mdprc 100 07 17 000Otto Bock Healthcare Products GmbHVoyager Evo rigid frame wheelchair BfArM
mdprc 099 07 17 000ThermoFisherPhadia 1000, all Instrument Software (ISW) versionsBfArM
mdprc 098 07 17 000Qualigen IncFastPack IP Vitamin D-ImmunoassayBfArM
mdprc 097 07 17 000Siemens Healthcare Diagnostics ProductSyva EMIT 2000 Tacrolimus und SirolimusBfArM
mdprc 096 07 17 000VIROTECH Diagnostics GmbHIPertussis Toxin gG Quantifizierungs-SetBfArM
mdprc 095 07 17 000Zimmer incPersona Partial Knee Guide Size 8BfArM
mdprc 041 07 17 001SIEMENSLantis Commander oder LantisBfArM
mdprc 046 04 17 001Roche Diagnostics CorpAccu-Chek Connect diabetes management app.BfArM
mdprc 091 07 17 000Zimmer BiometDRILL BIT MINI-QUICK CONNECTBfArM
mdprc 090 07 17 000Trinity Biotech USAMicroTrak Chlamydia trachomatis Direct SpecimenBfArM
mdprc 089 07 17 000SANO GmbHSANO Liftkar PT electric stairclimberBfArM
mdprc 088 07 17 000Roche Diagnostics CorpElecsys Digoxin, cobas e 801 moduleBfArM
mdprc 087 07 17 000OlympusColonovideoscopes CF-Y0067-LBfArM
mdprc 086 07 17 000Hain Lifescience GmbHGenoType SugarTol VER 1.0BfArM
mdprc 085 07 17 000Hain Lifescience GmbHAnalyzer (software) for FluoroType HSV VER 1.0BfArM
mdprc 084 07 17 000Ecolab Inc..Sekusept, Incidin, IncidurBfArM
mdprc 083 07 17 000Curetis GmbHUnyvero P55 Pneumonia Cartridge SetBfArM
mdprc 082 07 17 000BRAHMSB•R•A•H•M•S anti-Tgn RIABfArM
mdprc 061 07 17 000OHST Medizintechnik AGLE-CageBfArM
mdprc 060 07 17 000Shenzhen MindrayWATO EX-65, WATO EX-55, A5 and A7 anesthesia machinesBfArM
mdprc 059 07 17 000Chalice Medical LtdParaTherm Heater/CoolersBfArM
mdprc 058 07 17 000Asahi Kasei Medical Co., LtdAsahi APS-H Series HemodiafilterBfArM
mdprc 092 06 17 001SIEMENSArtis, X-Workplace, Sensis and ARCADIS SystemsBfArM
mdprc 042 07 17 000SIEMENSsyngo Workflow MLRBfArM
mdprc 040 07 17 000OrthofixPOWER DRILL TORQUE LIMITERBfArM
mdprc 039 07 17 000OlympusEVIS EXERA DUODENOVIDEOSCOPE TJF-145BfArM
mdprc 038 07 17 000EPflex Feinwerktechnik GmbHAAA Wire WiTRACBfArM
mdprc 099 06 17 000SIEMENSsyngo Imaging, syngo.plaza, syngo Dynamics, syngo Imaging XS, MagicLink A, syngo Workflow MLR, syngo Workflow SLR , syngo.via , and syngo.via ProtoNeoBfArM
mdprc 098 06 17 000Balt ExtrusionSONIC MICROCATHETER BfArM
mdprc 097 06 17 000Elekta LimitediGUIDE Software 2.2BfArM
mdprc 096 06 17 000Encore Medical, Lp3DKnee SystemBfArM
mdprc 095 06 17 000ICU Medical, IncI.V. Administration Sets with NanoClave manifoldBfArM
mdprc 094 06 17 000Mathys Ltd BettlachRM Classic flexible reaming shafts/countersink reamersBfArM
mdprc 093 06 17 000SIEMENSSPECT E.CAM, SPECT Symbia, SPECT MI, PET Biograph, PET Horion, PET Advanced WorkflowBfArM
mdprc 091 06 17 000Visus Technology Transfer JiveXBfArM
mdprc 090 06 17 000Zimmer BiometComprehensive Nano Humeral Component PPSBfArM
mdprc 089 06 17 000GETEMED Medizin - und informationstechnik AGHL7-WorklistServer/CommanderBfArM
mdprc 088 06 17 000Getinge Disinfection ABAtrium iCAST Balloon Expandable Covered StentsBfArM
mdprc 087 06 17 000Zimmer Inc.Trauma, Guide Wires 70cmBfArM
mdprc 086 06 17 000AngioDynamics Inc.Accu2i pMTA ApplicatorsBfArM
mdprc 085 06 17 000D.O.R.C. Dutch Opthalmic Research Center (International) B.VVitrectomy TDC Kit. (23 gauge / 0.6 mm)BfArM
mdprc 084 06 17 000Ethicon PROLENE Polypropyl. Suture; NUROLON Nylon SutureBfArM
mdprc 038 06 17 001Boston ScientificZurpaz Steerable Sheath 8.5F Asymmetric and Symmetric Curvehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155960
mdprc 053 06 17 000Sorin GroupAortic Arch Cannula..BfArM
mdprc 052 06 17 000Siemens Medical SolutionsArtis Systems in conjunction with the Artis tableBfArM
mdprc 049 06 17 000Regus Surgical BVBA29mm Blue REGUS Circular Stapler RCS-29BfArM
mdprc 046 06 17 000Pall International SARLPall "Ultipor" 100 Breathing System FilterBfArM
mdprc 044 06 17 000Zimmer incVarious Trauma and Extremity Instruments BfArM
mdprc 043 06 17 000BEGO Implant Systems GmbH & Co. KGBEGO Semados S. 3,25 L13 BfArM
mdprc 042 06 17 000Angiomed GmbH & Co. Medizintechnik KGSBK Cut Biopsy Needle / MS-cutBfArM
mdprc 039 06 17 000AesculapShuntassistantBfArM
mdprc 037 06 17 000Draeger Medical Systems IncInfinity Acute Care System (IACS). BfArM
mdprc 036 06 17 000Medela AGAXS Universal Aspiration TubingBfArM
mdprc 035 06 17 000SIEMENSMEVASIM, MEVASIM S, SIMVIEW 3000 and SIMVIEW NTBfArM
mdprc 034 06 17 000Tornier Inc611 Ankle Fusion Nail DrillBfArM
mdprc 018 06 17 000Carestream HealthDRX-Revolution Mobile X-Ray Systems..BfArM
mdprc 010 06 17 000Bentley InnoMed GmbHBeGraft Peripheral Stent Graft SystemBfArM
mdprc 009 06 17 000ExactechLogic Fit Tibial Tamp Head Instrument BfArM
mdprc 008 06 17 000ExactechEquinoxe Modular and No.-Modular Pilot Tip ReamersBfArM
mdprc 007 06 17 000HS Hospital ServiceAMICA PROBE.BfArM
mdprc 006 06 17 000Molnlycke Health Care AB.ProcedurePak trays containing specific i.e. codes and Polysurb SutureBfArM
mdprc 156 05 17 000Zimmer incVitality T27 Final Drivers and Torque-Limiting HandlesBfArM
mdprc 155 05 17 000ExactechNovation Calcar Planer Guide TipBfArM
mdprc 154 05 17 000Nutricia Medical DevicesFlocare Gastrostomy tubes (G-tube) ENFitBfArM
mdprc 143 05 17 000ConvaTecUnomedical Oxygen Masks,BfArM
mdprc 130 05 17 000GE HealthcareCarestation 620, 650 and 650cBfArM
mdprc 129 05 17 000Ortho-Clinical DiagnosticsORTHO Workstation BfArM
mdprc 128 05 17 000Zimmer BiometROSA Brain 3.0.0, ROSA Spine 1.0.2, ROSA One 3.1 .0 BfArM
mdprc 120 05 17 000DocLab GmbHD-Dimer Test BfArM
mdprc 119 05 17 000Renishaw PlcNeuromate Stereotactic Robotic SystemsBfArM
mdprc 111 05 17 000aap Implantate AGLOQTEQ diversBfArM
mdprc 110 05 17 000Beckman CoulterUniCel DxH 800/600 Cellular Analysis SystemsBfArM
mdprc 109 05 17 000EDAN Instruments, Inc.Patient Monitor, EtCO2 moduleBfArM
mdprc 108 05 17 000Leica Microsystems Inc.Leica M525BfArM
mdprc 107 05 17 000MikrogenrecomWell CampylobacterBfArM
mdprc 106 05 17 000Molnlycke Health Care AB.Barrier SetsBfArM
mdprc 105 05 17 000OptiMed Medizinische Instrumente GmbHSinus-SuperFlex-635BfArM
mdprc 104 05 17 000Radiometer America IncABL9 Analyzers ,.BfArM
mdprc 103 05 17 000Roche Diagnostics CorpOutput UnitBfArM
mdprc 102 05 17 000Shenzhen MindrayBeneview T1 Patient MonitorBfArM
mdprc 090 05 17 000Medi-Globe GmbHInflation/Deflation SystemsBfArM
mdprc 089 05 17 000IBA Dosimetry GmbHStealth ChamberBfArM
mdprc 084 05 17 000Zimmer BiometHexagonal Driver Medium 1.2BfArM
mdprc 083 05 17 000SSI DiagnosticaImmuView S. pneumoniae and L. pneumophila urinary antigen testBfArM
mdprc 082 05 17 000Siemens Medical SolutionsARTIS pheno systemsBfArM
mdprc 079 05 17 000Sekisui Diagnostics LLC.OSOM BVBLUE Test KitsBfArM
mdprc 077 05 17 000Halyard Health Co.Aero Blue performance surgical gown BfArM
mdprc 025 04 17 001ReFlow MedicalWingman 35 Crossing Catheterhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154310
mdprc 005 05 17 000Siemens Healthcare Diagnostics ProductIMMULITE®/IMMULITE® 1000 Lipopolysaccharide Binding Protein (LBP) BfArM
mdprc 004 05 17 000Siemens Healthcare Diagnostics ProductStratus® CS Acute Care™ CCRP TestPak BfArM
mdprc 003 05 17 000DiaSys Diagnostic Systems GmbHTruCal HbA1c liquid BfArM
mdprc 002 05 17 000bioMerieux InceMAG nucleic acid extraction system BfArM
mdprc 001 05 17 000DiaSorin IncLIAISON® Control Borrelia lgM Quant / Borrelia lgM II BfArM
mdprc 077 04 17 000Stryker Trauma AGStandard Lag Screw OmegaBfArM
mdprc 076 04 17 000Perouse MedicalDOLPHIN Inflation Device, CALIBER Inflation DeviceBfArM
mdprc 075 04 17 000DENTSPLY IMPLANTS MANUFACTURING GmbHImplant driver ProfileBfArM
mdprc 074 04 17 000B Braun Surgical SAOPTILENE 8/0 (0,4) 60CM 2XDR8BfArM
mdprc 049 04 17 000Zimmer BiometVanguard Rocc / Vanguard Alpina / Alpina APS / Alpina APR / Alpina Uni / Exception stem / Avantage cupBfArM
mdprc 048 04 17 000Yellow's Medical Instruments GmbHFrazier Sauger 3 mm, Länge 200 mm-SUGGF3533BfArM
mdprc 047 04 17 000SIEMENS18L6 HD transducer on the ACUSON S Family ultrasound systemsBfArM
mdprc 045 04 17 000Mizuho OSIWilson Frame PadsBfArM
mdprc 044 04 17 000Mielewasher-disinfectors PG 8527 / 8528 / 8535 / 8536BfArM
mdprc 043 04 17 000Indus Medical InstrumentsV Gripp Nova Variceal Ligation System BfArM
mdprc 042 04 17 000Halyard Health Co.Homepump C-Series with DEHP-free tubingBfArM
mdprc 041 04 17 000Arthrex IncSwiveLock SP Suture AnchorBfArM
mdprc 040 04 17 000aap Implantate AGVarioFit Classic cementfree hip prosthesesBfArM
mdprc 026 04 17 000Richard Wolf GmbHatraumatic compact Cysto-Urethroscope 25°BfArM
mdprc 024 04 17 000Merit Medical Systems Inc1mL Medallion® syringesBfArM
mdprc 023 04 17 000Intersurgical LimitedSolus Flexible - small paediatric, wire-reinforced laryngeal mask airway 2 / large paediatric, wire-reinforced laryngeal mask airway 2.5 / small adult, wire-reinforced laryngeal mask airway 3 / medium adult, wire-reinforced laryngeal mask airway 4 / large BfArM
mdprc 022 04 17 000ERBE Elektromedizin GmbHERGO handleBfArM
mdprc 021 04 17 000Advanced Medical Solutions Ltd.LiquiBand FIX8BfArM
mdprc 008 04 17 000Karl Storz GmbH & Co KGFLIPPTACK fixation buttonBfArM
mdprc 007 04 17 000Konigsee Implantate GmbHdrill bit f. quick coupling; Ø3.2 x 160 / spiral In 60 / quadr. spiral / cann. / inside / Ø1,7BfArM
mdprc 006 04 17 000MTW-Endoskopielithomy basket series "Easy-Catch"BfArM
mdprc 005 04 17 000ROHO Inc.HIGH / MID PROFILE single compartment cushion with Sensor Ready TechnologyBfArM
mdprc 004 04 17 000Schiller AGBattery for defibrillator FRED easyBfArM
mdprc 003 04 17 000SIEMENSRobot Imager and Gantry ImagerBfArM
mdprc 002 04 17 000SIEMENSArtis zee systems with SW VD11 and A100 generatorBfArM
mdprc 001 04 17 000Zimmer Biometvarious kits containing ACDABfArM
mdprc 092 03 17 000IBA Dosimetry GmbHProteusPLUSBfArM
mdprc 091 03 17 000PAUL HARTMANNHARTMANN VivanoTec / ATMOS S 042 NPWTBfArM
mdprc 089 03 17 000SALVIA medical GmbH & Co. KGnsive care ventilators elisa 600, elisa 800 and elisa 800BfArM
mdprc 088 03 17 000Shenzhen MindrayDryline II Water Traps Used with Beneview T Series Patient Monitors and A Series Anesthesia MachinesBfArM
mdprc 087 03 17 000Zimmer inciASSIST validation toolBfArM
mdprc 067 03 17 000Gunter Bissinger Medizintechnik GmbHORBITARIS handleBfArM
mdprc 066 03 17 000Integra LifeSciencesPANTA / XL nailsBfArM
mdprc 065 03 17 000Medtronic SAMiniMed 640G Insulin Infusion PumpBfArM
mdprc 064 03 17 000PAUL HARTMANNVivano Med Abdominal KitsBfArM
mdprc 063 03 17 000Silony MedicalVerticale pedicle / iliac screws dia. 8.2 / 9.2 / 10.2 mmBfArM
mdprc 029 03 17 000aap Implantate AGVarioLoc / SM straight stern / VarioCup hip prosthesesBfArM
mdprc 028 03 17 000aap Implantate AG1/3 tubular plate 3.5 / 2 and 3 round holesBfArM
mdprc 027 03 17 000Fresenius Medical CaremultiFiltratePRO devicesBfArM
mdprc 026 03 17 000Nobel BiocareMulti-unit Abutment Plus CC RP 25 mmBfArM
mdprc 025 03 17 000Philips HealthcareV60 respiratory ventilator with version 2.20 softwareBfArM
mdprc 024 03 17 000SIEMENSArtis systems with wireless foot switchBfArM
mdprc 023 03 17 000SIEMENSDigital Linear Accelerators of type ARTISTE™, ONCOR™ and PRIMUS™ running Control Console software version 13.0.302BfArM
mdprc 022 03 17 000Zimmer incvarious polyethylene implantsBfArM
mdprc 005 03 17 001Cook MedicalVarious Products with a Blue/Polyisoprene Valve Designhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152972
mdprc 007 03 17 0001stQ GmbHpseudophagic intraocular lens A4SW00 acrylic IOL / AddOn / spherical / hydrophilic / clear / -10,0 D to +10,0 DBfArM
mdprc 006 03 17 000Boston Scientific Cardiac Rhythm Management GroupLotus valve system..BfArM
mdprc 004 03 17 000DJO, LLCRSP monoblock / Turon impaction block fixturesBfArM
mdprc 003 03 17 000Inomed Medizintechnik GmbHball electrodeBfArM
mdprc 002 03 17 000PAUL HARTMANNCombiSets with BD 10 ml Plastipak catheter tip syringeBfArM
mdprc 001 03 17 000Schwarzer Cardiotek GmbHevo and eco cBfArM
mdprc 096 02 17 000SorinFlexTherm Heater Cooler Device BfArM
mdprc 095 02 17 000IBA Dosimetry GmbHProteusPLUS and ProteusONE.BfArM
mdprc 094 02 17 000DePuySynthesAiming Arm for DFN / combined / for PADBfArM
mdprc 093 02 17 000CuretisUnyvero BCU blood cultureBfArM
mdprc 092 02 17 000B Braun Medical IncMonosyn undyed 7/0 (0,5) 45 cm DSMP7BfArM
mdprc 091 02 17 000B Braun Medical IncBone Wax StickBfArM
mdprc 086 02 17 000CeMed GmbHDevon Light Gloves.BfArM
mdprc 084 02 17 000PHS Medical GmbHNuPortCT and C-PortCT port catheter systems containing F9.6 silicone cathetersBfArM
mdprc 083 02 17 000Molnlycke Health Care AB.ProcedurePak trays containing Syringe 100 ml 3parts Cath. tip Conc. W/LS AdapterBfArM
mdprc 082 02 17 000Menicon Co. Ltd.Menicon soft 72BfArM
mdprc 081 02 17 000GREATBATCH MEDICALMobiCath Bi-Directional Guiding SheathBfArM
mdprc 080 02 17 000Cook MedicalTIPSS-200 Transjugular Intrahepatic Portosystemic Shunt Procedure PackBfArM
mdprc 079 02 17 000B Braun Surgical SASafil Violet 2/0 (3) 12x45 cmBfArM
mdprc 049 02 17 001SIEMENSdigital linear accelerators of type ARTISTE / ONCOR / PRIMUShttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=153241
mdprc 073 02 17 000Beldico SAsterile disposable feeding bottles / sterile disposable breast milk collector setsBfArM
mdprc 072 02 17 000Brainlab AGExacTrac Vero 3.5.0 - 3.5.3BfArM
mdprc 071 02 17 000cardiowise GmbHXRCISE STRESS ECHO MED.BfArM
mdprc 070 02 17 000Ecomedis Medizintechnik GmbHdilator and sheath length 460 mm / d 1,7 mm (F5) / with haemostatic valveBfArM
mdprc 069 02 17 000Immucor GmbH.Kleihauer KitBfArM
mdprc 068 02 17 000Merete GmbHMetaToe ReadyToUse KitBfArM
mdprc 067 02 17 000MÖLLER-WEDEL GmbH & Co. KGCeiling Unit CU 5001/3 and CU 3-21/23BfArM
mdprc 066 02 17 000Smith & NephewVERSAJET II Hydrosurgery System ConsoleBfArM
mdprc 065 02 17 000Weinmann.MEDUCORE Easy battery packsBfArM
mdprc 048 02 17 000SIEMENSArtis zee systems with specific delivery lots of the A100Plus generator in combination with 2-focus Megalix Cat Plus tube unitsBfArM
mdprc 047 02 17 000SIEMENSdigital linear accelerators of type PRIMUS / MEVATRONBfArM
mdprc 046 02 17 000Samsung ElectronicsDR system GU60ABfArM
mdprc 045 02 17 000Hase Bikestrailer kit 24598 and 24875 in trikes without rear suspension Trix / Kettwiesel / Trets RehBfArM
mdprc 041 10 16 001OlympusTS100S Tubeset Standard Diego Elitehttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00142-1
mdprc 024 02 17 000C2 Therapeutics Inc.C2 CryoBalloon Controller CapBfArM
mdprc 023 02 17 0003M Health Care Ltd3M Tegaderm PICC CVC Securement Device + CHG I.V. Securement DressingBfArM
mdprc 022 02 17 000Anadolu Tip Teknolojileri A.S.FOCUS FORCE intraocular lensesBfArM
mdprc 021 02 17 000Christoph Miethke GmbH & Co. KGBohrloch Reservoir-SetBfArM
mdprc 020 02 17 000Diagnostica StagoDISPOSABLE STA-CUVETTES FOR HAEMOSTASIS ANALYSERS STA-R, STA R MAX, STA COMPACT, STA COMPACT MAXBfArM
mdprc 019 02 17 000Oertli Instrumente AGOS4 surgery system with EndolaserBfArM
mdprc 018 02 17 000Smith & NephewON CRUCIATE RETAINING NARROW Femoral Component SZ 5 RTBfArM
mdprc 033 03 16 001Valeant Pharmaceuticals North America LLCLASEREDGE 2.0 mm x 2.2 mm Trapezoid Angled 6 / Box SKU#E7601BfArM
mdprc 013 02 17 000Aesculapmonitor cable EV2-000086 (EinsteinVision 3D-Endoscopy Systems)BfArM
mdprc 012 02 17 000Arthrex IncArthrex Shoulder Suspension Towers .BfArM
mdprc 011 02 17 000OlympusENDOEYE HD II Video TelescopeBfArM
mdprc 063 01 17 001Siemens Healthcare Diagnostics ProductIMMULITE , IMMULITE 1000http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152220
mdprc 006 02 17 000Applied Medical Technology Inc.AMT Bridle - Nasal Tube Retaining SystemBfArM
mdprc 005 02 17 000BD Diagnostic SystemsPlastipak Syringe / Catheter tip with Luer slip adaptorBfArM
mdprc 004 02 17 000GS Elektromedizinische Geräte G. Stemple GmbHcorpuls 08/16 BI / 08/16 S BI / 08/16 E BIBfArM
mdprc 003 02 17 000Handicare LtdCarina Mobile LiftBfArM
mdprc 002 02 17 000Medtronic SACovidien Devon Light Gloves and non-sterile sub assembly kitsBfArM
mdprc 001 02 17 000Samsung ElectronicsUltrasound WS80A systemBfArM
mdprc 114 07 16 001bioMerieux IncNucliSENS easyMAG http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01551-1
mdprc 115 01 17 000Invacare Corporation….Dolomite Futura rollatorsBfArM
mdprc 114 01 17 000Gynesonics Inc.FA 04133 Sonata Case Kit, including SA 03605 Sonata Radiofrequency Ablation HandpieceBfArM
mdprc 113 01 17 000bioMerieux IncVIDAS 3 software v1.1.4BfArM
mdprc 112 01 17 000Carestream HealthDRX-Revolution Mobile X-Ray Systems.BfArM
mdprc 128 12 16 001Endologix IncAFX Endovascular AAA SystemBfArM
mdprc 111 01 17 000Siemens Healthcare DiagnosticskPCR SAMPLE PREP SUB-SYSTEM 96 DEEPWELL PLATE 2 MLBfArM
mdprc 110 01 17 000Blatchford Products LtdOrion3 Microprocessor Controlled Prosthetic Knee JointBfArM
mdprc 109 01 17 000bioMerieux IncBK Virus R-gene kitBfArM
mdprc 108 01 17 000Advanced Sterilization ProductsSTERRAD NX Sterilization SystemsBfArM
mdprc 104 01 17 000B Braun Surgical SASAFIL VIOLET 1 (4) 90CM HR40SBfArM
mdprc 103 01 17 000HemoCue A BHemoCue Hb 201 DM Analyzer / Glucose 201 DM Analyzer / Glucose 201 DM RT AnalyzerBfArM
mdprc 102 01 17 000Medtronic SAMedtronic Devon Light Gloves (Light Handle Covers)BfArM
mdprc 101 01 17 000Siemens Healthcare DiagnosticsN Latex HCY and N Latex HCY BCS XPBfArM
mdprc 100 01 17 000Trinity Biotech USABio-Rad RPR Assays and ComponentsBfArM
mdprc 099 01 17 000BD BiosciencesEclipse Needles ,BfArM
mdprc 098 01 17 000Gebrueder Martin GmbH & Co KG VENEX 360° Laser FibersBfArM
mdprc 067 01 17 000Beckman CoulteriChemVELOCITY Urine Chemistry StripsBfArM
mdprc 066 01 17 000Beckman CoulterUniCel DxH 600 / 800 Coulter Cellular Analysis System, blast Suspect MessagesBfArM
mdprc 065 01 17 000Intuitive Surgical Incda Vinci Xi Endoscopes with specific Endoscope ControllersBfArM
mdprc 064 01 17 000NIPRO CORPORATIONSurefuserPlus, Surefuser +BfArM
mdprc 062 01 17 000VIGMED ABSWiTCH Needle-Protected Safety CatheterBfArM
mdprc 061 01 17 000Surgical Specialties CorpBioSentry Tract Sealant SystemsBfArM
mdprc 052 01 17 000Stryker Leibinger GmbH & Co.KGMEDPOR facial and oculoplastic Sizer Set / TLS and SPG drain systemsBfArM
mdprc 042 01 17 000OlympusUretero-reno Endoscopes Ureterorenoskope URF-V2 / URF-V2R / URF-P6 / URF-P6RBfArM
mdprc 041 01 17 000AesculapGN200 - Lektrafuse HF Generator BipolarBfArM
mdprc 040 01 17 000Biomet IncOxford Fixed Lateral Bearing Size F RightBfArM
mdprc 039 01 17 000Merge Healthcare Corp.Merge Eye StationBfArM
mdprc 038 01 17 000Tracoe medical GmbHTRACOE vario REF 464 - Tracheostomy Tube - fenestrated with adjustable neck flangeBfArM
mdprc 030 01 17 000Gebrüder Martin GmbH & Co. KGdual pedal footswiches with SWAP mode - CPL 0509BfArM
mdprc 029 01 17 000Corin Group plcTrinity Acetabular Shell..BfArM
mdprc 028 01 17 000PENTAX Europe GmbHendoscope devicesBfArM
mdprc 027 01 17 000Philips HealthcareAllura Xper Systems.BfArM
mdprc 026 01 17 000SIEMENSmmomat Inspiration system with VB 30 und Biopsy functionalityBfArM
mdprc 025 01 17 000UROMED Kurt Drews KGmultiflex guidewireBfArM
mdprc 024 01 17 000Villa Sistemi Medicali S.p.A.pollo / DRF / EZ / EZ DRF , Clinodigit EVO and Clinodigit EVO @ / Juno DRF tablesBfArM
mdprc 023 01 17 000WeinmannSilicone resuscitator for adults and children from Fortune MedicalBfArM
mdprc 130 12 16 000Siemens Medical SolutionsBiograph mCT and mCT FlowBfArM
mdprc 129 12 16 000Philips HealthcareIQon Spectral Computed Tomography SystemsBfArM
mdprc 117 12 16 000Ortho-Clinical DiagnosticsORTHO VISION® AnalyzersBfArM
mdprc 116 12 16 000Hoffrichter GmbHCARAT I pro and CARAT II pro VentilatorsBfArM
mdprc 115 12 16 000Elekta Monaco RTP System.BfArM
mdprc 114 12 16 000Baxter Corp CanadaArtiset HD SN HC and Artiset HD DNL HCBfArM
mdprc 113 12 16 000AGFA Corp.NX image processing softwareBfArM
mdprc 105 12 16 000Aesculap Incposition headed reamer scaled D8.0mmBfArM
mdprc 104 12 16 000Amplitude GmbHInstrumentation for E.T.O.I.L.E® system - E.T.O.I.L.E® extension table (leg holder)BfArM
mdprc 103 12 16 000Wright Medical Technology, Inc.K-wire Ø1,2 mm L100 mm trocar tip non-sterileBfArM
mdprc 102 12 16 000Zimmer incScrewdriver handle/ T-shape/ cannulatedBfArM
mdprc 092 12 16 000Allen Medical SystemsArthrex S3 Arm Sleeve ConnectorBfArM
mdprc 091 12 16 000Anton Hipp GmbHTitanium Bone ScrewsBfArM
mdprc 090 12 16 000DiaSys Diagnostic Systems GmbHPRETERM RECALIBRATION OF oneHbA1c IS FOR INNOVASTARBfArM
mdprc 089 12 16 000Draeger Medical Systems IncOxylog 3000 and Oxylog 3000 plusBfArM
mdprc 088 12 16 000Fresenius Medical Care.sleep safe SetsBfArM
mdprc 087 12 16 000PROTiP MedicalNewBreez intralaryngeal prosthesisBfArM
mdprc 086 12 16 000SIEMENSArtis zee, Artis Q and Artis Q.zen systems with software version VD11BBfArM
mdprc 063 12 16 000Boston Scientific LtdINGEVITY™ MRI endocardial pacing leadsBfArM
mdprc 062 12 16 000ORGENTECAlegria Anti-Instrinsic Factor / Anti-Mycoplasma pneumoniae IgM Abs.BfArM
mdprc 061 12 16 000Process for PRF Company / ALL YOUNGi-PRF Tubes 10 mLBfArM
mdprc 060 12 16 000Roche Diagnostics Ltdcobas b 123 Systems.BfArM
mdprc 059 12 16 000Vaserum Ltd.Celt ACD Femoral Artery Vascular Closure Device 5F and 6FBfArM
mdprc 029 12 16 000Accuray IncCyberKnife SystemsBfArM
mdprc 024 08 16 001Laerdal Medical AsLaerdal Suction Unit (LSU) when used with the LSU NiMH BatteryBfArM, NCMDR
mdprc 020 12 16 000Zimmer incDiagnostikSuiteBfArM
mdprc 019 12 16 000Straumann USA, LLCDrill 1 and 2 / Twist Drill PRO / Starter SetBfArM
mdprc 018 12 16 000Samsung Electronics Co., Ltd.Mobile Digital X-Ray GM60ABfArM
mdprc 017 12 16 000Diagnostik Nord GmbHD-DIMK20 D-Dimer Rapid TestBfArM
mdprc 016 12 16 000TEM Innovations GmbHROTEM sigma cartridges complete + hepBfArM
mdprc 015 12 16 000Siemens Healthcare Diagnostics GmbHEMIT Ethosuximide Assay BfArM
mdprc 014 12 16 000Siemens Healthcare Diagnostics ProductIMMULITE / 1000 Turbo D-Dimer assayBfArM
mdprc 013 12 16 000Siemens Healthcare Diagnostics GmbHIMMULITE / 1000 Homocysteine assayBfArM
mdprc 012 12 16 000PerkinElmer Life and Analytical Sciences20ul Clear RoboRack TipBfArM
mdprc 011 12 16 000Dornier MedTech GmbHGeminiBfArM
mdprc 010 12 16 000advanced fiber tools GmbHRadial Fiber BfArM
mdprc 131 10 16 001Synthes Incsterile Reaming Rods for SynReamhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150554
mdprc 139 11 16 000MED-EL Elektro-Medizinische Geraete GmbHSONNET Mini Battery Pack CableBfArM
mdprc 079 11 16 002SIEMENSArtis zee with SW versions VC21 C, VD11 and Megalix Cat+ X-rayhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01474-1
mdprc 136 11 16 000GREATBATCH MEDICALOffset Reamer HandleBfArM
mdprc 135 11 16 000Smith & NephewReflection Dead Blow MalletBfArM
mdprc 134 11 16 000Origio A/SART-1023 Quinn’s Advantage Medium with HepesBfArM
mdprc 115 11 16 000Smith & NephewModular Neck Hip Prostheses of Modular SMF and Modular REDAPT Revision Femoral Hip SystemsBfArM
mdprc 114 11 16 000Siemens Healthcare Diagnostics ProductIMMULITE 2000 / XpiBfArM
mdprc 113 11 16 000Siemens Healthcare Diagnostics GmbHFlexLab power cordBfArM
mdprc 112 11 16 000LivaNova PLCS5 / C5 Perfusion SystemBfArM
mdprc 111 11 16 000Elekta Business Area Software Systems IMPAC Medical Systems Inc.Monaco 5.10 and 5.11.BfArM
mdprc 110 11 16 000DePuySynthes5 mm Flexible ShaftsBfArM
mdprc 109 11 16 000Aesculap Inc E.MOTION PS PRO MENISCAL COMPONENT F3L 20 mmBfArM
mdprc 108 11 16 000AbbVie Inc.PEG 20FR TubeBfArM
mdprc 107 11 16 000Philips HealthcareVarious Brilliance and Ingenuity Computed Tomography Systems .BfArM
mdprc 097 11 16 000Zimmer incRebalance TalarBfArM
mdprc 096 11 16 000Orion DiagnosticaQuikRead go InstrumentBfArM
mdprc 095 11 16 000IBL International GmbHParathyroid hormone intact ELISABfArM
mdprc 094 11 16 000Mathys Ltd BettlachbalanSys UNI convex PE inlay x/5BfArM
mdprc 093 11 16 000ExactechEquinoxeBfArM
mdprc 091 11 16 000Concert Medical LLCGaleo Pro Coronary GuidewireBfArM
mdprc 087 11 16 000ArcRoyalDevon Light GloveBfArM
mdprc 085 11 16 000SuZhou Sensogen Biotech Co.,LtdProline D-Dimer Pro rapid test (IVD) BfArM
mdprc 084 11 16 000Nihon Kohden CorpAutomated external defibrillators cardiolife AED-2100KBfArM
mdprc 083 11 16 000Dutch Diagnostics BVD-Dimer Rapid TestsBfArM
mdprc 082 11 16 000BRAHMSPlGF PLUS KRYPTOR QC BfArM
mdprc 081 11 16 000W. Droh GmbHEndotracheal Tube with Murphy eyeBfArM
mdprc 080 11 16 000Trinity Biotech USAMicroTrak CMV HA 2000BfArM
mdprc 078 11 16 000Molnlycke Health Care ABProcedurePak trays containing Light Handle Cover (Devon TMBfArM
mdprc 077 11 16 000Corin Group plcBIOLOX delta.BfArM
mdprc 076 11 16 000Boston Scientific Cardiac Rhythm Management GroupLOTUS Edge Valve SystemBfArM
mdprc 075 11 16 000Beckman CoulterAccess Ostase Calibrator Kit and Access Ostase QC KitBfArM
mdprc 074 11 16 0003M Health Care LtdUniversal Electrosurgical PadBfArM
mdprc 057 11 16 000Trinity Biotech USAMicroTrak Syphilis TPHA 100 / 200 / 500 BfArM
mdprc 056 11 16 001Teleflex MedicalLMA Mucosal Atomization DevicesBfArM
mdprc 055 11 16 000Leonhard Lang GmbHDefibrillation electrode SCHILLER DF87C and DF56C BfArM
mdprc 054 11 16 000CepheidXpert MRSA / SA BCBfArM
mdprc 015 05 16 001Nipro CorpSurefuserSwissmedic
mdprc 031 11 16 000Weinmannadaptive servo-ventilation (ASV) therapyBfArM
mdprc 016 11 16 000Siemens Medical SolutionsOMATOM Definition AS and SOMATOM Definition FlashBfArM
mdprc 015 11 16 000EKF DIAGNOSTIC GmbHBiosen Glucose / Lactate ConsumablesBfArM
mdprc 014 11 16 000Draeger Medical Systems IncIACS SW Version VG5.0BfArM
mdprc 013 11 16 000DiaSys Diagnostic Systems GmbHCholinesterase FSBfArM
mdprc 012 11 16 000Brainlab AGFemoral and Tibial Cutting Block Adapter BfArM
mdprc 011 11 16 000Bosch + Sohn GmbH u. Co. KGboso TM-2430 PC2BfArM
mdprc 010 11 16 000S.I.M.E.O.N. Medical GmbH & Co. KGcentral axis system BfArM
mdprc 009 11 16 000Roche Diagnostics LtdGLU / LAC / UREA (BUN) Cassette, cobas b 221 systemBfArM
mdprc 008 11 16 000nal von minden GmbHNADAL RSV rapid testN/A
mdprc 007 11 16 000Mitsubishi Chemical Medience CorporationPATHFAST MyoglobinBfArM
mdprc 155 10 16 000Stryker NeurovascularGuider Guide CatheterBfArM
mdprc 154 10 16 000Randox Laboratories LtdEvidence lnvestigator EV3602BfArM
mdprc 153 10 16 000Occlutech International ABLAA OccluderBfArM
mdprc 152 10 16 000MED-EL Elektro-Medizinische Geraete GmbHSONNET Rechargeable Battery Pack Cover Micro BlackBfArM
mdprc 151 10 16 000Integra LifeSciencesdrill dia. 1.9 mmBfArM
mdprc 150 10 16 000C R Bard IncPop-On Self-Adhering Male External CatheterBfArM
mdprc 142 10 16 000Synthes IncFACET WEDGEBfArM
mdprc 141 10 16 000ORGENTECORG 908MX Anti Mumps Virus IgMBfArM
mdprc 140 10 16 000MAQUET IncHCU 30 Heater-Cooler UnitsBfArM
mdprc 139 10 16 0003M Health Care LtdSelectiCure L19BfArM
mdprc 138 10 16 000NeovascNeovasc Reducer KitBfArM
mdprc 137 10 16 000gabmedgabControl D-Dimer rapid testBfArM
mdprc 136 10 16 000Fresenius Medical Care.AV-Set B-RBfArM
mdprc 135 10 16 000Siemens Medical SolutionsCombi Dockable Table NeurosurgeryBfArM
mdprc 134 10 16 000MediRoxPT Owren’s GHI131-10 SIBfArM
mdprc 133 10 16 000Siemens Healthcare DiagnosticsVitamin D Total BfArM
mdprc 144 08 16 001Stryker CommunicationsTrident Universal Impactor / Positioner BfArM
mdprc 122 10 16 000RESEARCH INSTRUMENTS LTDEZ‐TipBfArM
mdprc 121 10 16 000Christoph Miethke GmbH & Co. KGproGAV 2.0BfArM
mdprc 132 07 16 001Zimmer incAir Dermatome II BfArM
mdprc 096 10 16 000Zimmer incNexGen LPS FemoralBfArM
mdprc 095 10 16 000SentreHeart, IncFindrWIRZBfArM
mdprc 094 10 16 000Promisemed Hangzhou Meditech Co. Ltd.Betafine Universal Pen Needles 30G-8 mmBfArM
mdprc 093 10 16 000Molnlycke Health Care ABProcedurePak kits and traysBfArM
mdprc 092 10 16 000METSIS MEDIKAL LTD, STILife-Point DefibrillatorsBfArM
mdprc 091 10 16 000Implant Direct LLCSpectra-System / ScrewPlant / ScrewPlus / ScrewIndirect / ScrewDirect / ScrewRedirect / GoDirect / Legacy / RePlant / RePlus / ReActive / SwishPlant / SwishPlus / SwishActive / InterActive Systems BfArM
mdprc 090 10 16 000GE HealthcareMAC 600 / 800 / 1200 / 1600 / 2000 / 3500 / 5000 / 5500 / 5500 HDBfArM
mdprc 089 10 16 000FUJIFILM Medical SystemsSynapse PACS softwareBfArM
mdprc 088 10 16 000Brainlab AGiPlan RT Radiation Treatment Planning SoftwareBfArM
mdprc 087 10 16 000Becton Dickinson & Co. (BD)CD79b PEBfArM
mdprc 086 10 16 000Trinity Biotech USAMicroTrak Syphilis TPHA PK TestsBfArM
mdprc 085 10 16 000Stryker CommunicationsLFIT Anatomic CoCr V40 Femoral HeadsBfArM
mdprc 084 10 16 000IBA Dosimetry GmbHproton therapy systemsBfArM
mdprc 083 10 16 000GFE Blut mbHautoX Extraction KitBfArM
mdprc 082 10 16 000Bio-Techne/ R&D SystemsHuman sTfR Quantikine IVD ELISA KitBfArM
mdprc 081 10 16 000Alphatec Spine IncSimple Holder-HandleBfArM
mdprc 080 10 16 000AB SCIEX Pte. LtdVarious Mass Spectrometer SystemsBfArM
mdprc 057 10 16 000Ulrich GmbH & Co. KGcomprehensive posterior system open and percutaneousBfArM
mdprc 056 10 16 000Trumpf Medical Systems, Inc.Operating Table Tops for Modular Exchangeable Table Top SystemsBfArM
mdprc 055 10 16 000Toshiba Medical Systems CorporationXarioBfArM
mdprc 054 10 16 000Roche Diagnostics Corpcleaning procedure of rack traysBfArM
mdprc 053 10 16 000Focus Diagnostics IncStop Solution (EL0105) and ELISA kitsBfArM
mdprc 052 10 16 000Focus Diagnostics IncWest Nile Virus IgM DxSelectBfArM
mdprc 051 10 16 000Focus Diagnostics IncWest Nile Virus IgG DxSelect kit (EL0300G)BfArM
mdprc 050 10 16 000Dako Denmark A/SHER2 CISH pharmDx Kits.BfARM
mdprc 049 10 16 000Biomet 3i IncLow Profile products BfArM
mdprc 048 10 16 000Maquet Cardiopulmonary AGSERVO-airBfArM
mdprc 047 10 16 000Signus Medizintechnik GmbHRotaio Cervical Disc Prosthesis BfArM
mdprc 046 10 16 000OHST Medizintechnik AGPrimara SF PfanneBfArM
mdprc 045 10 16 000i-Medical Ophthalmic International GmbHi-Visc 1.6 % and i-Visc 2.0 %BfArM
mdprc 044 10 16 000Albomed GmbHPe-Ha-Visco 10 x 2,0 % 2,0 ml BoxBfArM
mdprc 043 10 16 000Teleflex MedicalEZIO Manual Driver BfArM
mdprc 042 10 16 000Siemens Healthcare Diagnostics GmbHSyva EMIT II plus opiate assayBfArM
mdprc 040 10 16 000Leonhard Lang GmbHdefibrillation electrode Skintact DF29N BfArM
mdprc 039 10 16 000Ecolab Inc..Klerpack BD Syringe Multi-PackBfArM
mdprc 040 09 16 000Teleflex MedicalRUSCH - TracheoFlex Tracheostomie TubesBfArM
mdprc 039 09 16 000Ortho-Clinical DiagnosticsVITROS Chemistry Products Slide AssaysBfArM
mdprc 038 09 16 000Integra LifeSciencesStraight Ventricular Catheter F8, 25 cm / Integral Lumbar Drainage-Set / CUSA® Dissectron® Fingertip Laparoscopic CannulaBfArM
mdprc 037 09 16 000Human Care HC Sweden ABAltair, HeliQ, and Roomer S Overhead LiftsBfArM
mdprc 145 08 16 000ThermoFisher Scientific Microbiology PerthQMS Everolimus ImmunoassayBfArM
mdprc 143 08 16 000Novacare GmbHAPM 440X BfArM
mdprc 142 08 16 000Helioscopie Medical ImplantsHeliosphere Newtech BfArM
mdprc 141 08 16 000Focus Diagnostics Inc.Anaplasma Phagocytophilum IFA IgM Test KitBfArM
mdprc 116 08 16 000WaisMed LtdNIO-ABfArM
mdprc 115 08 16 000Sorin Group.Perceval Sutureless Heart Valve. manufactured by Sorin Group Italia S.r.l. and LivaNova Canada Corp.BfArM
mdprc 114 08 16 000Siemens Healthcare Diagnostics GmbHTriglyceride concentrated (TRIG_c) reagentBfArM
mdprc 113 08 16 000Bio-Rad Medical DiagnosticsTANGO infinityBfArM
mdprc 112 08 16 000Biomet 3i IncOSSEOTITE Certain Implant BfArM
mdprc 111 08 16 000Beckman CoulterUniCel DxH 600 and 800 Coulter Cellular Analysis SystemsBfArM
mdprc 110 08 16 000Siemens Healthcare Diagnostics ProductBCS / BCS XP - INNOVANCE ETPBfArM
mdprc 109 08 16 000B Braun …OPTILENE 4/0 (1,5) 90 CM 2XHRC22BfArM
mdprc 108 08 16 000Zimmer incDynesys pedicle Screw + Set Screw 6.0x35BfArM
mdprc 107 08 16 000Stryker OrthopaedicsScorpio Patella Assembly InstrumentsBfArM
mdprc 106 08 16 000Siemens Medical Solutions Dimension Vista System Calcium Flex reagent cartridge BfArM
mdprc 105 08 16 000medavis GmbHDICOM Importer Pro BfArM
mdprc 104 08 16 000HeartWare IncHVAD pumps BfArM
mdprc 103 08 16 000Elekta Monaco BfArM
mdprc 102 08 16 000Bard Pcripheral Vascular (BPV)Bardex 3 Way Male 30 cc / 50 cc Preshaped Ribbed Sac Lubricious Coated Catheter BfArM
mdprc 101 08 16 000bioMerieux Inc Mueller Hinton 2 agar + 5 % sheep bloodBfArM
mdprc 075 08 16 000Elekta Business Area Software Systems IMPAC Medical Systems Inc.the modification of the gantry base drive wheel assembly Precise series Linac / Product: Digital AcceleratorBfArM
mdprc 065 08 16 000Esaote S.p.A.MylabTwiceBfArM
mdprc 064 08 16 000Esaote S.p.A.G-scan Brio Magnetic Resonance System.BfArM
mdprc 063 08 16 000Fresenius Medical Care.HERMANN GASTROSTOMY DRESSING SETBfArM
mdprc 062 08 16 000interco GmbHdynamic seat shell system with undercarriage AKTIVLINEBfArM
mdprc 061 08 16 000Phoenix Surgical lnstrumentsSilver Tracheostomy TubesBfArM
mdprc 060 08 16 000Welcare Industries SpaSinaqua Dermal Glove / Sinaqua Wipe / Easyderm GloveBfArM
mdprc 029 08 16 000SIEMENSpatient table (Ysio / Ysio Max / Multix Fusion)BfArM
mdprc 028 08 16 000Alcon.AcrySof IQ IOL with UltraSert Implantation System BfArM
mdprc 027 08 16 000Bescot Healthcare UK Ltd.Zestica fertility applicatorBfArM
mdprc 026 08 16 000Bredent Medical GmbH and Co KGmini²SKY gingiva formerBfArM
mdprc 025 08 16 000Direct Flow MedicalTranscatheter Aortic Valve SystemBfArM
mdprc 023 08 16 000SIEMENSsyngo RT Therapist.BfArM
mdprc 022 08 16 000Novus Scientific ABTIGR Matrix Surgical Mesh.BfArM
mdprc 108 04 16 001Haemonetics CorpCell Saver Elite disposable processing kits BfArM
mdprc 021 08 16 000Smith & NephewRENASYS Sterile Transparent Film Contained in RENASYS Dressing KitsBfArM
mdprc 011 08 16 000Peter BrehmIBS-PEEK TLIF IIBfArM
mdprc 010 08 16 000Nobel BiocareNobelParallel CC Guided Surgery KitBfArM
mdprc 008 08 16 000BIOTRONIK UK LtdPasseo-18 peripheral balloon catheterBfArM
mdprc 007 08 16 000Arthrex IncAngel Blood Access KitBfArM
mdprc 006 08 16 000Bradshaw Medical Inc.Axial Torque Limiting DriverBfArM
mdprc 182 07 16 000Teleflex MedicalRUSCH-Catheter for radiation measurementBfArM
mdprc 181 07 16 000TECOmedical GroupTECO Intact Proinsulin ELISA KitBfArM
mdprc 180 07 16 000Smith & NephewWhipknot Soft Tissue Cinch #5 SuturesBfArM
mdprc 179 07 16 000MICON Medizintechnik GmbHreusable silicon hoses for insufflators and suction / irrigation pumpsBfArM
mdprc 178 07 16 000Mathys Ltd BettlachtwinSys double offset adaptorBfArM
mdprc 177 07 16 000M. Schilling GmbHacti-fine spine-ject spinal needleBfArM
mdprc 176 07 16 000Kivex Biotec A/SG210 IncubatorsBfArM
mdprc 175 07 16 000Xavant TechnologySTIMPOD NMS410 / NMS450 Nerve Stimulator.BfArM
mdprc 131 07 16 000The Binding SiteLK018.OPT Optilite Freelite Lambda Kit BfArM
mdprc 130 07 16 000Silony MedicalRoccia MultiLIF Probe 13x34 mm 5° LorBfArM
mdprc 129 07 16 000Shenzhen Mindray Bio-medical Electronics Co., Ltd.BeneVision N22 and N19 patient monitorsBfArM
mdprc 128 07 16 000Roche Diagnostics Corpcobas b 123BfArM
mdprc 127 07 16 000Metrax GmbHPRIMEDIC AkuPak LITEBfArM
mdprc 126 07 16 000Lohmann & Rauscher InternationalKit packs for the BD Plastipack Syringes and BD Oral-SyringesBfArM
mdprc 125 07 16 000Litos GmbHcore hole drill midi Ø=3.3 mm AO and core hole drill maxi/FFS/PFS Ø=4.3 mm AOBfArM
mdprc 124 07 16 000Elekta Business Area Software Systems IMPAC Medical Systems Inc.MOSAIQ BfArM
mdprc 123 07 16 000DiaSys Deutschland Vertriebs-GmbHGanestin reagentBfArM
mdprc 122 07 16 000bioMerieux IncVIDAS Estradiol IIBfArM
mdprc 121 07 16 000Beckman CoulterImmunotech RIA Estradiol KitsBfArM
mdprc 120 07 16 000ArcRoyal LtdBD syringes included in procedure packsBfArM
mdprc 119 07 16 000Zimmer incAvenir Müller Stem 6 Lateral uncemented and Avenir Müller Stem 4 Standard uncementedBfArM
mdprc 118 07 16 000Synthes GmbHAdapter Colibri / Electric Pen Drive and Adapter small Colibri (II) / Small Battery Drive (II)BfArM
mdprc 117 07 16 000Stryker Trauma AGFemoral Nail A/R Ø 11x280BfArM
mdprc 116 07 16 000Stryker Instruments2.3 mm Tapered RouterBfArM
mdprc 115 07 16 000Codan Argus AGtransducer of DPT-6000 seriesBfArM
mdprc 113 07 16 000BD Diagnostic SystemsColumbia III Agar with 5 % Sheep BloodBfArM
mdprc 112 07 16 000Bard Pcripheral Vascular (BPV)ArcticSun ArcticGel Neonatal PadBfArM
mdprc 111 07 16 000Air Liquide Medical SystemsDANUBE HP supply system BfArM
mdprc 102 07 16 000MÖLLER-WEDEL GmbH & Co. KGSurgical microscope HS Hi-R 1000 and HS Hi-R 700 in combination with navigation systemsBfArM
mdprc 101 07 16 000Halyard HealthHomepump C‐Series Silicone Elastomeric Pumps (non‐DEHP)BfArM
mdprc 088 07 16 000W. Droh GmbHdisposable fiber optic blade Miller typeBfArM
mdprc 087 07 16 000Merge Healthcare Corp.Eye Station and Eye Care PACSBfArM
mdprc 086 07 16 000ERGO-FIT GmbH & Co. KGXRCISE STRESS ECHO MEDBfArM
mdprc 085 07 16 000Zimmer incTAPERLOC HIP LATERALISED PC STEM 15.0 / 17.5 mm 12/14 Taper BfArM
mdprc 084 07 16 000B Braun Medical IncPerfusor LineBfArM
mdprc 039 07 16 000Neurodan A/SActiGait Implantable drop foot stimulatorBfArM
mdprc 038 07 16 000Braun Melsungen AGNovosynBfArM
mdprc 025 07 16 000Biofrontera AGBF-RhodoLED Photodynamic Therapy LampsBfArM
mdprc 126 06 16 000Med-linkPulse Oximeter Probes BfArM
mdprc 093 06 16 0003M Health Care LtdPICC/CVC Securement Device + Tegaderm I.V. Advanced Securement DressingBfArM
mdprc 092 06 16 000Biofrontera AGBF-RhodoLED Photodynamic Therapy LampsBfArM
mdprc 091 06 16 000Biokit USA IncQuantia DigitoxinBfArM
mdprc 089 06 16 000Biokit USA IncQUANTEX DIGITOXINBfArM
mdprc 088 06 16 000bioMerieux IncHaemophilus Chocolate agar (HAEM)BfArM
mdprc 086 06 16 000DiaSorin IncLIAISON Multi-Control Tumor MarkersBfArM
mdprc 085 06 16 000IBA Dosimetry GmbHProteusPLUSBfArM
mdprc 084 06 16 000icotec AGPedicle Starter AwlBfArM
mdprc 083 06 16 000Lohmann & Rauscher InternationalMetalline products with metal needlesBfArM
mdprc 082 06 16 000Medset Medizintechnik GmbHAdapter cable ECG-Top Art.-No. AAZ135016-01BfArM
mdprc 081 06 16 000Steris CorpV-PRO 1 / V-PRO 1 Plus / V-PRO maX Low Temperature Sterilization SystemsBfArM
mdprc 066 06 16 000Beckman CoulterALT OSR6X07 / Glucose-Stat OSR6X40BfArM
mdprc 065 06 16 000EndoChoice IncFuse 1C ColonoscopesBfArM
mdprc 064 06 16 000FUJIFILM Medical Systemsdigital mammography system AMULET (FDR MS-1000) with Biopsy unitBfArM
mdprc 063 06 16 000SIEMENSStreamLAB Automation Solutions / Aptio Automation/ FlexLab / Hettich Centrifuge Bucket Model 4464-RBfArM
mdprc 062 06 16 000Thermo Fisher Scientific OyCEA / CD66e Ab-2BfArM
mdprc 061 06 16 000Tosoh CorporationST AIA-PACK iE2 / hsE2BfArM
mdprc 060 06 16 000X Spine Systems IncCalix P Peek Lumbar System and Calix T Peek Lumbar SystemBfArM
mdprc 038 06 16 000Mathys Ltd BettlachAffinis Fracture, Inverse, and Short implants with Ti/CaP coating,BfArM
mdprc 037 06 16 000Randox Laboratories LtdAmmonia ReagentsBfArM
mdprc 036 06 16 000Siemens Medical SolutionsDimension Vista Flex Homocysteine (HCYS) reagent cartridgeBfArM
mdprc 089 05 16 001Weinmann.MEDUMAT Transport and MEDUMAT StandardBfArM
mdprc 166 05 16 000Tosoh CorporationAutomated Enzyme Immunoassay System / AnalyzerBfArM
mdprc 165 05 16 000Siemens Healthcare Diagnostics ProductN Latex HCY / N Latex HCY (BCS XP) reagentBfArM
mdprc 164 05 16 000Oxoid Div ThermoFisher Scientific Microbiology PerthColumbia CNA Aesculin Selective Agar /BfArM
mdprc 163 05 16 000NuvectraNuvectra, Algovita Spinal Cord Stimulation System Clinical ProgrammerFDA, BfArM
mdprc 162 05 16 000Medtronic IncResolute Integrity Zotarolimus-Eluting Coronary Stent SystemBfArM
mdprc 161 05 16 000IBL International GmbHproteusPLUS and proteusONEBfArM
mdprc 160 05 16 000Erba Lachema s.r.ovarious IVDBfArM
mdprc 159 05 16 000Abbott Vascular-Cardiac Therapies dba Guidant CorporationFIRMap CathetersBfArM
mdprc 136 05 16 000Wieland Dental +Technik GmbH & Co. KGZenostar MT Color and Zenostar MT Color ImpulseBfArM
mdprc 135 05 16 000TEOXANE S.A.Teosyal Ultimate and Teosyal PureSense UltimateBfArM
mdprc 134 05 16 000Synthes Inc8 mm × 360 mm Flexible ShaftsBfArM
mdprc 133 05 16 000Redcord ASrope lock Axis BfArM
mdprc 132 05 16 000OHST Medizintechnik AGinsertion instrument Primaro Cup and Primaro Cup MIS BfArM
mdprc 131 05 16 000Novus Scientific ABTIGR Matrix Surgical MeshBfArM
mdprc 130 05 16 000MedicinaSilo Bags for the treatment of gastroschisisBfArM
mdprc 129 05 16 000Lumenis IncLightSheer DESIREBfArM
mdprc 128 05 16 000InnoTERE GmbHVELOX 3 ccBfArM
mdprc 127 05 16 000Elekta InciGUIDE 2.1, iGUIDE 2.2BfArM
mdprc 126 05 16 000CareFusion.AVEA VentilatorBfArM
mdprc 125 05 16 000bioMerieux IncARGENE productsBfArM
mdprc 124 05 16 000bioMerieux IncchromID MRSA SMART BfArM
mdprc 123 05 16 000B Braun Medical Inc Dialog+ Dialysis MachinesBfArM
mdprc 122 05 16 000Alphatec Spine IncOsseofix sterile package implant 5.5 mmBfArM
mdprc 121 05 16 000Abbott Molecular Inc Sub Abbott LaboratoriesIRIDICABfArM
mdprc 090 05 16 000privelop-spine AGHygro-c Inserter BfArM
mdprc 088 05 16 000Nipro CorpTRUEresult Blood Glucose Test StripsBfArM
mdprc 087 05 16 000Handicare LtdEva Mobile LiftsBfArM
mdprc 086 05 16 000Edwards LifesciencesCommander Delivery SystemBfArM
mdprc 085 05 16 000Beckman CoulterDigitoxin KitsBfArM
mdprc 084 05 16 000Zimmer incNormed Fender Titanium PlatesBfArM
mdprc 083 05 16 000Zimmer incVarious Trabecular Metal Knee and Hip ProsthesesBfArM
mdprc 082 05 16 000Smith & NephewR3° 0 Degree XLPE Acetabular Liner 32 mm ID X OD 48 mmBfArM
mdprc 081 05 16 000SIEMENSBiograph TruePoint systems / Biograph mCT and mCT Flow systemsBfArM
mdprc 080 05 16 000Invacare Corporation….FOX wheelchair BfArM
mdprc 045 05 16 000Ziehm Imaging GmbHmobile X-ray devices / C-armsBfArM
mdprc 044 05 16 000DePuySynthesCortex Screw ø 4.5 mmBfArM
mdprc 043 05 16 000Brainlab AGExacTrac Vero 3.5BfArM
mdprc 042 05 16 000BioFire Diagnostics IncFilmArray BCID kitsBfArM
mdprc 041 05 16 000AB GermaFootrest vacuum pumps BfArM
mdprc 021 05 16 000Kawasumi Laboratories IncA.V. Fistula Sets for Hemodialysis BfArM
mdprc 020 05 16 000EUROSETS s.r.l.Trilly Oxygenator BfArM
mdprc 019 05 16 000Accriva DiagnosticsHemochron Microcoagulation System APTT Test CuvettesBfArM
mdprc 018 05 16 000Zimmer incVarious Sports Medicine and Trauma Implants and InstrumentsBfArM
mdprc 017 05 16 000PIERENKEMPER GmbHStimaWELL 120MTRSBfArM
mdprc 064 04 16 001Permobil ABLSM - LifeStand Multiposition WheelchairBfArM
mdprc 016 05 16 000OptiMed Medizinische Instrumente GmbHZelos PTA-balloon catheter BfArM
mdprc 014 05 16 000Cook EndoscopyFluoroSet Radiographic Tubal Assessment Set / Kumpe Access Catheter / Selective Salpingography Catheter with Beacon TipBfArM
mdprc 109 04 16 000Roche Diagnostics CorpDigitoxin ReagentBfArM
mdprc 107 04 16 000Algostim LLCAlgovita Implantable Pulse Generator StimulatorsBfArM
mdprc 099 04 16 000Merz pharmceuticalsEtermis 2 BfArM
mdprc 098 04 16 000Biosense Webster Inc.PENTARAY catheters BfArM
mdprc 097 04 16 000Biomet Inc360 TIBIAL AUGMENT BfArM
mdprc 082 04 16 000Terumo Cardiovascular Systems CorporationCDI Blood Parameter Monitoring System 500BfArM
mdprc 081 04 16 000Horiba ABX SASABX PENTRA 400 and PENTRA C400 BfArM
mdprc 080 04 16 000Hologic IncThinPrep 5000 Processor with AutoloaderBfArM
mdprc 079 04 16 000DiaSys Diagnostic Systems GmbHHbA1c IS INNOVASTARBfArM
mdprc 066 04 16 000Weinmann.OXYWAY pressure reducer for Fast and Click types BfArM
mdprc 065 04 16 000Teleflex MedicalPleur-evac Chest Drainage SystemsBfArM
mdprc 063 04 16 000DiaSorin IncfT4-CTK KitBfArM
mdprc 062 04 16 000Applied Medical ResourcesDirect Drive Clip AppliersDawha Medical
mdprc 061 04 16 000DePuy International LtdDuraloc Option LPW Poly InsertsBfArM
mdprc 058 04 16 000Boston Scientific CorporationWATCHMAN FLX Left Atrial Appendage (LAA) Closure Device BfArM
mdprc 055 04 16 000Stryker CommunicationsELITE, Heavy Duty and Footed attachmentsBfArM
mdprc 054 04 16 000Smith & NephewBIRMINGHAM HIP RESURFACING Extraction KitBfArM
mdprc 053 04 16 000Siemens Medical SolutionsIONTRISBfArM
mdprc 052 04 16 000Siemens Medical Solutions SOMATOM FORCE with VA50A / VA50A_SP2 - kernel Hp38 BfArM
mdprc 051 04 16 000OssurÖSSUR LIL’ANGEL HALO VESTBfArM
mdprc 010 04 16 000TRUMPF Medizin Systeme GmbH + Co. KGLeg Holder HEAVY T padsBfArM
mdprc 009 04 16 000Nipro Corp .ELISIO-19HBfArM
mdprc 008 04 16 000ICU Medical, IncIV Administration Sets with ChemoLock PortsBfArM
mdprc 007 04 16 000Carl Zeiss Meditec IncIntraocular lenses CT ASPHINA 404V and CT ASPHINA 409MVBfArM
mdprc 006 04 16 000bioMerieux IncM. HINTON 2 SHEEP BLOOD 90 20PLBfArM
mdprc 005 04 16 000Becton Dickinson & Co. (BD)BD Retic-CountBfArM
mdprc 199 03 16 000TRUMPF Medizin Systeme GmbH + Co. KGSurgical Table Accessories Manufactured before September 2004BfArM
mdprc 198 03 16 000Siemens Medical SolutionsYsio systems with fixed detector in wall standBfArM
mdprc 197 03 16 000Siemens Healthcare DiagnosticsERSANT kPCR Molecular System Sample PreparationBfArM
mdprc 196 03 16 000Mitsubishi Heavy Industries Ltd. VERO / MHI-TM2000 Linear Accelerator SystemBfArM
mdprc 195 03 16 000Jiangsu Suyun Medical Materials Co. Ltd.Silicone catheterBfArM
mdprc 194 03 16 000INTEGRA INSTRUMENT GROUPMonopolar Instruments / Bipolar Instrument Handle BfArM
mdprc 193 03 16 000BRAHMSFT4 RIA TracerBfArM
mdprc 192 03 16 000Beckman Coulter, Inc..MicroScan LabPro Information Manager System. BfArM
mdprc 170 03 16 000Vascular Solutions IncGuardian II Hemostasis Valve BfArM
mdprc 169 03 16 000TEM Innovations GmbHall ROTEM sigma complete cartridges BfArM
mdprc 168 03 16 000Smith & NephewTC-PLUS Primary Fixed Tibial Components VKS (cemented and non-cemented)BfArM
mdprc 167 03 16 000Focus Diagnostics Inckits Simplexa HSV 1 & 2 Direct, Direct Amplification Discs (DAD)BfArM
mdprc 166 03 16 000DePuySynthesProximal Femoral Nail (PFN)BfArM
mdprc 165 03 16 000Biomet IncRHK KNEE BEARINGBfArM
mdprc 108 03 16 000AlerePima AnalyserBfArM
mdprc 107 03 16 000Bard Pcripheral Vascular (BPV)Bard TruGuide Disposable Coaxial Biopsy NeedlesBfArM
mdprc 106 03 16 000MEDOS Medizintechnik AGdeltastream MDC, i-cor and iLA activve consolesBfArM
mdprc 105 03 16 000Peter BrehmIBS II spreaders PT 6 mm / 8 mm / 10 mm and IBS II spreaders O 6 mm / 8 mmBfArM
mdprc 104 03 16 000Spiegelberg GmbH & Co KGSilverline Lumbar Drainage CatheterBfArM
mdprc 103 03 16 000Zimmer inc3.7 mm D and 4.1 mm D Trabecular Metal implantsBfArM
mdprc 102 03 16 000Siemens Medical SolutionsAXIOM Artis and Artis zee systems, Artis zee and Artis Q/Q.zen systemsBfArM
mdprc 087 03 16 000Thermo Fisher Scientific OyCholinesteraseBfArM
mdprc 086 03 16 000RedaxPVC Trocar catheter CH 24BfArM
mdprc 085 03 16 000GIMMI GmbHmonitor mounts and support arms with rotatable 75 / 100 adaptationBfArM
mdprc 084 03 16 000Fresenius Kabi Ltdenteral syringe Freka Connect ENLock 5 mlBfArM
mdprc 040 03 16 000Sterisets International B.V.Citra-Lock S 4%, Dirinco BV BfArM
mdprc 039 03 16 000SPIGGLE & THEIS MedizintechnikInflation Devices BfArM
mdprc 038 03 16 000MBR Optical Systems GmbHhaemospect blood screening unit BfArM
mdprc 037 03 16 000LivaNova PLCEndotoxin BfArM
mdprc 036 03 16 000Haemonetics Corp.MCS+/LDP W/FILTER 994CF-E / CONC PLT & PLS SET W/FILTER 998CF-E / PBSC SET (225 ml LATHAM) 0970E-BfArM
mdprc 035 03 16 000Fritz Stephan GmbHventilator STEPHANIEBfArM
mdprc 034 03 16 000Volcano CorpR-100 sterile equipment cover / SpinVision sterile equipment coverBfArM
mdprc 032 03 16 000Smith & NephewRENASYS GO External Power Supply Units BfArM
mdprc 031 03 16 000SIEMENSCios Alpha mobile C-Arm system BfArM
mdprc 030 03 16 000SERAG-WIESSNER GmbHSERANOX sternum wireBfArM
mdprc 029 03 16 000Rayner Intraocular Lenses LtdHydrophilic Acrylic Single Use lntraocular Lens system packsBfArM
mdprc 028 03 16 000Medtronic IncSynchroMed II Implantable Infusion PumpBfArM
mdprc 027 03 16 000Medtronic Inc CardioVascularReveal LINQ Insertable Cardiac Monitor (ICM)BfArM
mdprc 026 03 16 000Johnson & Johnson Medical GmbHOmrix Pressure Regulator.. BfArM
mdprc 025 03 16 000Ergosafe Products LLCLEG PRESS 4xxx MED und SQUAT PRESS 4xxx MEDBfArM
mdprc 024 03 16 000Biosensors Europe SABioMatrix Flex and BioMatrix NeoFlex Drug Eluting Coronary Stent System (DES) BfArM
mdprc 023 03 16 000ReliantHeartHeartAssist5 Controller Driveline CablesBfArM
mdprc 022 03 16 000Miele Container and Trolley washersBfArM
mdprc 021 03 16 000Macopharma blood bag filter LCRD2 BfArM
mdprc 020 03 16 000Hitachi Medical CorpARIETTA 60 & 70 series BfArM
mdprc 019 03 16 000DePuy International LtdKirschner Wire 1.6 mm, with drill tip, length 200 mm / sterileBfArM
mdprc 018 03 16 000Dentsply International IncATLANTIS Abutment TitaniumBfArM
mdprc 017 03 16 000Dako Denmark A/SAPAAP mouse MonoclonalBfArM
mdprc 016 03 16 000Wundmed GmbH & Co. KGWundnahtstreifenBfArM
mdprc 015 03 16 000Websinger GmbHDouble Airway Splint I and II BfArM
mdprc 014 03 16 000Vygon UK LtdCVC sets SAFE BfArM
mdprc 013 03 16 000Mitsubishi Heavy Industries Ltd.VERO / MHI-TM2000 Linear Accelerator System. BfArM
mdprc 012 03 16 000GambroAK 200 S and AK 200 ULTRA S dialysis machines BfArM
mdprc 011 03 16 000Bistos Co. Ltd.Medical head lamp BT-410 BfArM
mdprc 010 03 16 000Aseptix Professional Products BVSterimax Wipes BfArM
mdprc 059 02 16 000Christoph Miethke GmbH & Co. KGBorehole PortBfArM
mdprc 058 02 16 000GLOOR AGpressure regulator Swiss optio variusBfArM
mdprc 057 02 16 000SIEMENSQuench line of superconducting magnetsBfArM
mdprc 056 02 16 000SIEMENSsyngo RT Therapist / syngo RT OncologistBfArM
mdprc 016 02 16 000Vision RTAlignRT/GateRT connected to Siemens Linacs.BfArM
mdprc 015 02 16 000MAQUET IncFLOW-i C20, C30 and C40BfArM
mdprc 014 02 16 000ITD GmbHmonitor mounts and support arms with rotatable VESA 75 / 100 adaptationBfArM
mdprc 013 02 16 000Inlog S.A.S.EdgeLab versions 6.4.0.x, 6.4.1.x, 6.5.0.xBfArM
mdprc 012 02 16 000Baxter Healthcarevarious RF Syringe StripsBfArM
mdprc 104 12 15 000MAQUET IncSurgical light spring arms ( ANAULUX, MAQUET ALM XTEN )BfArM
mdprc 103 12 15 000MedisoAnyScan S, SC, SCP productsBfArM
mdprc 075 12 15 000Zimmer incPersona EM Proximal Tube and Persona EM Distal RodBfArM
mdprc 074 12 15 000Mathys Ltd Bettlachoptimys stems lateralBfArM
mdprc 055 12 15 000aap Biomaterials GmbHSM straight stemBfArM
mdprc 054 12 15 000Spiegelberg GmbH & Co KGICP - MonitorsBfArM
mdprc 053 12 15 000Hocoma AGcampaign for the main connection cable BfArM
mdprc 052 12 15 000DePuySynthesSynReam Medullary Reamer Head, Ø 13.5 mm BfArM
mdprc 051 12 15 000Cook IncOsteo-Site® Murphy Side Bevel Bone Biopsy Needle SetBfArM
mdprc 084 09 15 001alamedics GmbH & Co. KGala octaBfArM
mdprc 078 09 14 001Philips HealthcarePatient Support Stands for StitchingBfArM , FDA
mdprc 018 12 15 000Siemens Medical SolutionsDimension Vista System Flex® reagent cartridge and urine stabilizer B2MICBfArM
mdprc 017 12 15 000Richard Wolf GmbHburrs BfArM
mdprc 016 12 15 000HOYA Holdings N.V.HOYA iSert IOLs BfArM
mdprc 007 12 15 000Zimmer incMaxican Titanium Screw 4.5x 55mm cannulated BfArM
mdprc 006 12 15 000Smith & NephewPiGalileo Hip Pressfit Impactor NAV Instruments BfArM
mdprc 005 12 15 000Elekta IncOncentra Simulation BfArM
mdprc 128 11 15 000Halyard Health Co.ON-Q Pump with ONDEMAND Bolus ButtonBfArM
mdprc 106 11 15 000Synthes IncExpert Tibial Nail 9.0 mm, cannulated, length 270 mmBfArM
mdprc 105 11 15 000Applied Diabetes ResearchInsulin Syringe ReservoirsBfArM
mdprc 040 11 15 000Zimmer incTwist Drill 25x95 mm Cannulated 1,2 mm Thread 30 mmBfArM
mdprc 039 11 15 000Smith & Nephew incPERI-LOC Volar Distal Radius 3 Hole PlateBfArM
mdprc 038 11 15 000SIEMENSHemoglobin A1c_3BfArM
mdprc 037 11 15 000Ortho-Clinical DiagnosticsORTHO BioVue CassettesBfArM
mdprc 036 11 15 000OlympusTHUNDERBEAT forcepsBfArM
mdprc 029 11 15 000Zien Medical Technologies, IncPenBlade Safety ScalpelBfArM
mdprc 027 11 15 000SoluscopeSoluscope Serie 4 PA.BfArM
mdprc 106 01 15 001Clinical InnovationsEbb Complete Tamponade System - CTS-1000BfArM
mdprc 085 10 15 000Boston ScientificRotaWire Elite Guidewire and wireClip Torquer Guidewire Manipulation Device BfArM
mdprc 084 10 15 000Immucor GmbH.Pak12BfArM
mdprc 083 10 15 000Biocompatibles LtdTheraSphere-Y-90 Glass MicrospheresBfArM
mdprc 082 10 15 000Siemens Medical SolutionsMODULARIS Variastar BfArM
mdprc 081 10 15 000GFE Blut mbHIC Kit lot with the number 091501BfArM
mdprc 080 10 15 000BrainLABBrainlab iMRI Registration Matrix for GE BfArM
mdprc 079 10 15 000Alpha Omega Engineering Ltd.Neuro Omega system BfArM
mdprc 078 10 15 000AbbottARCHITECT i2000SR SystemBfArM
mdprc 055 10 15 000PerkinElmer Life and Analytical SciencesLifeCycle for Prenatal ScreeningBfArM
mdprc 054 10 15 000BrainLABBrainlab Radiation Treatment Planning SoftwareBfArM
mdprc 053 10 15 000AQUIS GmbHCutilyth sensitive Gel / Neutrosteralyth-Gel BfArM
mdprc 052 10 15 000ALPINION MEDICAL SYSTEMS Co., Ltd.EN3-10 transducer and E-CUBE 9BfArM
mdprc 051 10 15 000Alba BioscienceAnti-Leb, clone LEB2BfArM
mdprc 026 10 15 000DMB Apparatebau GmbHInstalling a second EO Sensor for Low Temperature SterilizerBfArM
mdprc 103 09 15 000Smiths MedicalPORT-A-CATH® Plastic Hub Needles BfArM
mdprc 102 09 15 000Pyng Medical Corp.MATResponder TourniquetBfArM
mdprc 101 09 15 000Alcon Grieshaber AG23 G and 25 G Valved Entry SystemsBfArM
mdprc 100 09 15 000Agency for Medical InnovationsMCS-Port Obturator / MCS5000BfArM
mdprc 099 09 15 000VBM Medical IncCuff Controller (Shiley Pressure Control)BfArM
mdprc 098 09 15 000AGFA Corp.Digital Radiography X-Ray Systems DR 400BfArM
mdprc 077 09 15 000BRAHMSNeopterin EIA BfArM
mdprc 037 09 15 000Hippokratec GmbHsilicon tube 1008 BfArM
mdprc 036 09 15 000Ludwig Bertram GmbHRUSSKA Rollator Standard and Rollator AluminiumBfArM
mdprc 035 09 15 000JenaValve Technology GmbHJenaValve prosthesisBfArM
mdprc 034 09 15 000Hitachi Medical Corpitachi MRI Systems AIRIS Vento, AIRIS Vento LT, APERTO Eterna, APERTO Lucent, Echelon and OasisBfArM
mdprc 033 09 15 000Aesculap IncMETHA Titanium Cone Adapter (Neck) BfArM
mdprc 009 09 15 000Stryker Leibinger GmbH & Co.KGDisposable paper filter for sterilization containers BfArM
mdprc 008 09 15 000Siemens Medical SolutionsACUSON SC2000 ultrasound systems.BfArM
mdprc 006 09 15 000bioMerieux IncchromID S. aureus range productsBfArM
mdprc 005 09 15 000B Braun Medical IncEasypump II Elastomeric Infusion PumpsBfArM
mdprc 190 08 15 000MEDICHEM Diagnostica GmbH & Co. KGMedidrug ALC VB BfArM
mdprc 184 08 15 000Weinmann.MEDUMAT Transport ventilator BfArM
mdprc 183 08 15 000Waldemar LINK GmbH & CoLink Endo-Modell Tibial Plateau Sets” and “Link Endo-Modell Replacement Sets BfArM
mdprc 182 08 15 000SIEMENSCios Alpha mobile C-arm x-ray System. BfArM
mdprc 181 08 15 000Fresenius Kabi Ltd.Compoflex and Composelect bloodbag systems BfArM
mdprc 180 08 15 000Bayer Healthcare LLC..certain Medrad® Mark 7 Arterion® Injection Systems BfArM
mdprc 163 08 15 000Thermo Fisher Scientific Oy B•R•A•H•M•S Calcitonin RIA BfArM
mdprc 076 04 15 001Siemens Healthcare Diagnostics Dade Activated Cephaloplastin Reagent BfArM
mdprc 162 08 15 000SIEMENSSupplementary Reagents for CFT (Sheep Blood),BfArM
mdprc 161 08 15 000Philips HealthcarePhilips Ingenuity TF PET/MR system BfArM
mdprc 143 08 15 000Yuyao Shengchang Medical Instrument FactoryHyperventilation maskBfArM
mdprc 142 08 15 000Xion GmbhHInsufflation hose, silicone BfArM
mdprc 141 08 15 000Sunrise Medicalwheelchair Quickie Jive UP BfArM
mdprc 140 08 15 000SIEMENSFolate Ascorbic AcidBfArM
mdprc 139 08 15 000Siemens Medical SolutionsDigital Linear Accelerators/Update for the syngo RT Therapist™ software and the Control Console software BfArM
mdprc 138 08 15 000Richard Wolf GmbHProximal Lighting Insert BfArM
mdprc 137 08 15 000DiaSys Diagnostic Systems GmbHNEFA FS BfArM
mdprc 136 08 15 000Carestream Health Inc Div Onex CorpDRX Evolution Systems w/Premium and Full Featured Wall stands BfArM
mdprc 135 08 15 000Synthes IncLocking Screw Diameter 3.5mm, Length 14mmBfArM
mdprc 134 08 15 000DiaSys Diagnostic Systems GmbHTruCal Lp (a) 21 calibrator BfArM
mdprc 133 08 15 000C2F IMPLANTSLEXA femoral componentsBfArM
mdprc 132 08 15 000Volcano CorpPioneer Plus Intravascular Ultrasound Guided Re-Entry CathetersBfArM
mdprc 131 08 15 000Transonic Systems IncHQD Flow Probe BfArM
mdprc 130 08 15 000TOPRO Industri ASThe rollator TOPRO Troja 2G BfArM
mdprc 129 08 15 000Smith & Nephew OrthopaedicTRIGEN 8/7 mm x 24 cm Humeral Nail BfArM
mdprc 128 08 15 000Roche Diagnostics Corpcobas 6800 / 8800 systems BfArM
mdprc 127 08 15 000Philips BurtonPhilips G60 patient monitor BfArM
mdprc 126 08 15 000Ondal medical system GmbHM6 service head BfArM
mdprc 125 08 15 000Brainlab AG ExacTrac 6.0 Patient Positioning System BfArM
mdprc 124 08 15 000Boston Scientific LtdAngioJet Thrombectomy Sets BfArM
mdprc 123 08 15 000Bayer Healthcare LLC..the Intrauterine Contraceptives Mirena and Nova T 380 BfArM
mdprc 118 08 15 000Vascular Solutions IncTurnPike Spiral and TurnPike Gold Catheters BfArM
mdprc 117 08 15 000Tosoh CorporationST AIA-PACK 25-OH Vitamin D CALIBRATOR SET BfArM
mdprc 116 08 15 000Samsung ElectronicsLABGEOPT Lipid Test 5S and LABGEOPT Lipid Test 5 BfArM
mdprc 115 08 15 000Medtronic IncEOPA Arterial CannulaBfArM
mdprc 114 08 15 000MAQUET Incadjustable positioning elementsBfArM
mdprc 113 08 15 000Mani IncMANI Trocar Kit BfArM
mdprc 112 08 15 000International Biophysics CorpAortic Punch products BfArM
mdprc 111 08 15 000HumanOptics AGMicroSil IF and MicroSil IFT intraocular lensesBfArM
mdprc 110 08 15 000Analyticon Biotechnologies AGFluitest CREA PAP and for all products based on the “Trinder Reaction”BfArM
mdprc 071 08 15 000Eizo CorporationRadiForce RX650, 6MP Color LCD MonitorBfArM
mdprc 070 08 15 000Medtronic Spine LLC CoKYPHON 11 Gauge Bone Access NeedlesBfArM
mdprc 069 08 15 000Lohmann & Rauscher InternationalGazin Balls 2+3 and Gazin Balls 2+2BfArM
mdprc 068 08 15 000Bard Pcripheral Vascular (BPV)Rival PTA Dilatation Catheters BfArM
mdprc 057 08 15 000Stryker OrthopaedicsTriathlon Inserts, Triathlon X3 PS Tibial Insert #5 11mm, Triathlon X3 TS Plus Tibial Insert #3 19mm BfArM
mdprc 056 08 15 000Pulsion Medical SystemsPiCCO catheter BfArM
mdprc 055 08 15 000OptiMed Medizinische Instrumente GmbH 200 mm sinus-SuperFlex-635 self-expanding nitinol stent systemBfArM
mdprc 053 08 15 000DiaSys Diagnostic Systems GmbHInnovaStar values of GL Control N and P BfArM
mdprc 052 08 15 000Vectura GmbHAKITA JET and AKITA² APIXNEB inhalation systems manufactured by Vectura GmbH BfArM
mdprc 051 08 15 000Siemens Medical SolutionsEnzygnost Anti-HCV 4.0 on BEP 2000 / BEP 2000 Advance System BfArM
mdprc 050 08 15 000Rochester Medical CorpMagic Hydrophilic-coated Female Intermittent Catheter products BfArM
mdprc 049 08 15 000Cadence Science, IncPerfectum Tuberculin Glass Syringe & Micro‐Mate Tuberculin Glass Syringe BfArM
mdprc 048 08 15 000Sorin GroupMitroflow Model 12, LXA and DLBfArM
mdprc 047 08 15 000OptiMed Medizinische Instrumente GmbHOptiSplint EndoprosthesisBfArM
mdprc 046 08 15 000Biosense Webster Inc A Johnson & Johnson Co.nMARQ Circular Irrigated CathetersBfArM
mdprc 013 08 15 000OMNIlife scienceAssy, 2mm and 4mm Offset Femoral Alignment Locating Guide Revision Femur BfArM
mdprc 012 08 15 000Mermaid MedicalM-Biopsy Coaxial lntroducer Needle BfArM
mdprc 007 07 15 000Nobel BiocareAbutment Retrieval Instrument and AbutmentBfArM
mdprc 006 07 15 000Nihon Kohden CorpCentral Monitors model CNS-6201 BfArM
mdprc 005 07 15 000Ivoclar Vivadent AG..IPS e.max Ceram and related products BfArM
mdprc 004 07 15 000Baxter HealthcareArtis/Evosys Dialysis System BfArM
mdprc 003 07 15 000Draeger Medical Systems IncDraeger monitor holders with AC2000 BfArM
mdprc 002 07 15 000Curefab Technologies GmbHCurefab CS device BfArM
mdprc 001 07 15 000B. Braun (Aesculap)Celsite Access Ports. BfArM
mdprc 139 06 15 000Nihon Kohden CorpTelemetry SystemsBfArM
mdprc 138 06 15 000HS Hospital ServiceAMICA ProbeBfArM
mdprc 137 06 15 000EIT Emerging Implant Technologies GmbHEIT PLIF ShaverBfArM
mdprc 136 06 15 000Synthes IncGuide Wire Diameter 2.8mm, Length 180mm, w/ThreadBfArM
mdprc 135 06 15 000Molnlycke Health Care ABProcedurePak. BfArM
mdprc 134 06 15 000Biomet IncVarious orthopedic productsBfArM
mdprc 099 06 15 000PAUL HARTMANNCombiSets containing Raucodrape incision foil BfArM
mdprc 095 06 15 000MEDOS Medizintechnik AGBattery packs for deltastream MDC console and iLA activve console BfArM
mdprc 094 06 15 000Draeger Medical Systems IncFabius MRI anaesthesia systemsBfArM
mdprc 093 06 15 000Boston Scientific Cardiovascular GroupCLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording SystemBfArM
mdprc 079 06 15 000US EndoscopyVelocity Biopsy Valve BfArM
mdprc 078 06 15 000Sorin GroupDisinfection and Cleaning of Sorin Heater Cooler 1T and 3T devices BfArM
mdprc 077 06 15 000PTWPTW UNIDOS webline Typ T10021, T10022 und T10023BfArM
mdprc 076 06 15 000nal von minden GmbHGlass capillary tubes of the CRP testsBfArM
mdprc 075 06 15 000Lohmann & Rauscher InternationalRaucodrape Surgical Incise Drape (single product) and Set systems KitPack concerned (with integratd Incise Drape) BfArM
mdprc 074 06 15 000Intuitive Surgical Inc5 mm Thoracic Graspers Used with da Vinci S and da Vinci Si Surgical SystemsBfArM
mdprc 062 06 15 000Zimmer inc4.5 mm Cortical Screws Labeled as Compatible with the M/DN SystemBfArM
mdprc 060 06 15 000Vascutek LimitedGelseal Straight BfArM
mdprc 056 06 15 000B. Braun (Aesculap)Coroflex Isar Coronary stentBfArM
mdprc 055 06 15 000Alcon Laboratories IncAlcon Monarch IOL Delivery System CartridgesBfArM
mdprc 031 06 15 000Tracoe medical GmbHTRACOE vario Tracheostomy TubeBfArM
mdprc 030 06 15 000MikrogenrecomScan Version 3.4, Build-Versionen below 62BfArM
mdprc 028 06 15 000MAQUET IncMAGNUS Hybrid OR tableBfArM
mdprc 027 06 15 000Edwards LifesciencesIntraClude Intra-Aortic Occlusion DevicesBfArM
mdprc 017 06 15 000Philips Healthcareadaptive servo ventilation (ASV) therapyBfArM
mdprc 016 06 15 000GE HealthcareNeuromuscular Transmission Modules (E-NMT-00 and M-NMT-02)BfArM
mdprc 015 06 15 000Dermaroller GmbhDermaroller MCBfArM
mdprc 014 06 15 000Boston Scientific Cardiac Rhythm Management GroupELIANCE 4-FRONT single coil defibrillation leadsBfArM
mdprc 112 05 15 000Hoffrichter GmbHRespiratory therapy devices Trend II, point and Vector etBfArM
mdprc 111 05 15 000Synthes Inc Chisel BladeBfArM
mdprc 110 05 15 000OrthofixGalaxy Unyco Diaphyseal tibia sterile kitBfArM
mdprc 109 05 15 000Philips HealthcarePhilips Model AFFINITI 50 Ultrasound System ..BfArM
mdprc 108 05 15 000Philips HealthcarePhilips Model AFFINITI 70 Ultrasound SystemBfArM
mdprc 058 05 15 000Smith & Nephew ULTRA FAST-FIX Knot Pusher/Suture Cutter, Straight BfArM
mdprc 057 05 15 000Philips HealthcarePhilips Ultrasound QLAB 10.0 ( on Xcelera)BfArM
mdprc 056 05 15 000ALTATEC GmbH Camlog Screw Line Implant BfArM
mdprc 042 05 15 000Human GmbhHOMOCYSTEINE liquiUVBfArM
mdprc 041 05 15 000Roche Diagnostics LtdD-Dimer Gen.2BfArM
mdprc 040 05 15 000Siemens Medical SolutionsArtis systems used in conjunction with the Artis tableBfArM
mdprc 114 05 14 001Baxter HealthcarePatient Control Module, 2 ml, Single-packhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=134369
mdprc 015 05 15 000Labor Dr. Merk & Kollegen GmbH Hemolytic system for CFTBfArM
mdprc 014 05 15 000Hansen Medical, Inc.Magellan Robotic SystemBfArM
mdprc 013 05 15 000Getinge DisinfectionED FLOWBfArM
mdprc 012 05 15 000CardioKinetix IncPARACHUTE Implant System BfArM
mdprc 011 05 15 000Biometrix B.VThorametrix chest drainage system BfArM
mdprc 002 05 15 000Siemens Healthcare Diagnostics GmbHIMMULITE/IMMULITE 1000BfArM
mdprc 140 04 15 000Ethicon Inc ETHICON VICRYL SutureBfArM
mdprc 138 04 15 000AndocorRetrograde Cardioplegia CannulaBfArM
mdprc 075 04 15 001Medtronic SynchroMed® II Implantable Drug Infusion PumpBfArM
mdprc 136 04 15 000CareFusionAVEA® Ventilator All ModelsBfArM
mdprc 135 04 15 000SIEMENSsyngo Workflow MLR .BfArM
mdprc 134 04 15 000Smith & NephewEP-FIT PLUS/MPF Ceramic Insert DeltasBfArM
mdprc 127 04 15 000Biosense Webster Inc A Johnson & Johnson Co.SMARTABLATE Radio-Frequency Generator SystemsBfArM
mdprc 126 04 15 000Boston ScientificLotus Valve System ..BfArM
mdprc 109 04 15 000Zimmer incNeumann Titan Arthrodesis Plate ProximalBfArM
mdprc 104 04 15 000Spectron Gas Control Systems GmbHthe Spectron Multi Med Light valvesBfArM
mdprc 103 04 15 000Spectron Gas Control Systems GmbHthe Spectron Multi Med Light valvesBfArM
mdprc 074 04 15 000BrainLABExacTrac 6.x Patient Positioning System:BfArM
mdprc 073 04 15 000Frei AG Aktive Rehatreatment tables AXXIS, GYM and THERAGYMBfArM
mdprc 072 04 15 000LVD Biotech S.L.iVascular iVolution Self-Expanding Peripheral Stent SystemBfArM
mdprc 071 04 15 000Rehaforum MedicalRehaforum Rollator with Eurobrake SilverBfArM
mdprc 065 04 15 000Morcellator Morcellator Handpiece for Morce Power PlusBfArM
mdprc 064 04 15 000B Braun AV Sets with Recirculation SystemBfArM
mdprc 063 04 15 000ArthroCare CorporationSpeedLock 6.5mm Implant with Inserter Handle BfArM
mdprc 044 04 15 000SIEMENSArtis Q/Q.zen systemsBfArM
mdprc 043 04 15 000Instrumentation LaboratoryILAB TAURUS SYSTEMS WITH ISE BfArM
mdprc 030 04 15 000Zimmer incInnex Femoral component SC S+ cem. RBfArM
mdprc 012 04 15 000Fresenius Kabi LtdACD-A bagsBfArM
mdprc 011 04 15 000OlympusEVIS EXERA III VIDEOGASTROSCOPE GIF-XP190NBfArM
mdprc 010 04 15 000Ulrich GmbH & Co. KGneon3 CrosslinksBfArM
mdprc 132 03 15 000PerkinElmer Life and Analytical SciencesNEOBASE NON-DERIVATIZED ASSAY SOLUTIONSBfArM
mdprc 131 03 15 000Intuitive Surgical IncVinci Xi Surgical SystemBfArM
mdprc 130 03 15 000FIAB SpAFIAB Disposable electrodes for Defibrillation series F7965BfArM
mdprc 129 03 15 000Biomet IncBiolox Delta Ceramic Head 28mm Standard NeckBfArM
mdprc 113 03 15 000TeraRecon IncAquarius iNtuition Client ViewerBfArM
mdprc 112 03 15 000Smith & Nephew BIRMINGHAM HIP™ Modular HeadBfArM
mdprc 111 03 15 000S.I.M.E.O.N. Medical GmbH & Co. KGGTP 14 without electric & Sim.Carry GTP 8 AC 2000BfArM
mdprc 110 03 15 000Life Technologies CorporationDRB1-13 SSP UniTray, Allset Gold Plus SSPBfArM
mdprc 109 03 15 000DePuySynthesLCS COMPLETE RPS Knee SystemBfArM
mdprc 108 03 15 000Codman NeurosciencesCODMAN CERTAS Therapy Management System (TMS) 1st generationBfArM
mdprc 065 03 15 000SIEMENSSyngo.PlazaBfArM
mdprc 064 03 15 000Endologix IncNellix EndoVascular Aneurysm Sealing SystemBfArM
mdprc 055 03 15 000Weinmann.MEDUMAT ventilators with the blue test bag BfArM
mdprc 054 03 15 000Mint Medical GmbHMint Lesion™BfArM
mdprc 049 03 15 000Biosensors BioPath 035 Paclitaxel releasing over the wire (OTW) PTA balloon catheterBfArM
mdprc 042 03 15 000PathoFinder B.V.Respiratory RT PCR Kit v2.0BfArM
mdprc 041 03 15 000IBL International GmbHCalcitonin ELISA (NM59011)BfArM
mdprc 040 03 15 000Fresenius Medical care Puristeril 340 GENIUS canisterBfArM
mdprc 019 03 15 000Ondal medical system GmbHAC 2000 spring armsBfArM
mdprc 018 03 15 000Beckman CoulterAccess 2 SystemsBfArM
mdprc 012 03 15 000Standard Dignostics BIOLINE Malaria Ag products containing single-use buffer ampouleBfArM
mdprc 011 03 15 000Smith & Nephew OrthopaedicGENESIS II non-porous Tibial BaseplateBfArM
mdprc 010 03 15 000Peter BrehmSealing Screw Tibia UCBfArM
mdprc 127 02 15 000Alcon Grieshaber AG.Alcon Small Volume Syringes 200μL Luer-LokBfArM
mdprc 126 02 15 000aap Biomaterials GmbHPierced screw, diameter 7.5, Cannulated screw 7.5, length 80 mm, thread length 32 mm, titaniumBfArM
mdprc 125 02 15 000VedaLabTroponin I-Check-1 deviceBfArM
mdprc 124 02 15 000Philips HealthcareAllura FC, Anti-collision improvementBfArM
mdprc 123 02 15 000Carestream Health Inc Div Onex CorpTrophy IRIX scissor arm of the Trophy IRIX Intra-oral X-Ray SystemBfArM
mdprc 120 02 15 000OrthofixISKD - Intramedullary Skeletal Kinetic Distractor (Limb Lengthener)BfArM
mdprc 119 02 15 000Johann Stiegelmeyer & Co GmbHStiegelmeyer hospital beds from the "Seta" rangeBfArM
mdprc 118 02 15 000Baxter HealthcareMiniCaps with Povidone-lodineBfArM
mdprc 097 02 15 000TRILUX LEUCHTEN GmbHTRILUX Medical Examination Light L 50, ceiling-mounted versionBfArM
mdprc 096 02 15 000MicroPort OrthopedicsEVOLUTION Tibial BaseBfArM
mdprc 083 02 15 000Sunrise Medicalwheelchair Breezy PariXBfArM
mdprc 082 02 15 000Lohmann & Rauscher InternationalPro-ophta Eye Dressing S and DBfArM
mdprc 007 02 15 001Carl Zeiss Meditec IncFORUM ViewerBfArM , FDA
mdprc 040 02 15 000Zimmer incZimmer Persona Tibial Articular Surface InsertersBfArM
mdprc 039 02 15 000Air Liquide Medical SystemsMonnal T50 ventilatorsBfArM
mdprc 038 02 15 000Becton Dickinson & Co. (BD)CDC Anaerobe 5 Sheep Blood Agar, TrypticaseTM Soy Agar & Columbia Agar with 5 Sheep BloodBfArM
mdprc 022 02 15 000Synthes Inc48mm Multi-Loc ScrewBfArM
mdprc 021 02 15 000Siemens Healthcare Diagnostics GmbHDimension Vista® 500 Intelligent Lab System or Dimension Vista® 1500 Intelligent Lab System.BfArM
mdprc 020 02 15 000Ondal medical system GmbHACROBAT 2000 spring armsBfArM
mdprc 019 02 15 000BioCer Entwicklungs-GmbHSurgical Mesh Implant TiO2MeshBfArM
mdprc 010 02 15 000Philips HealthcarePhilips Model MPT7-4 Transesophageal TransducerBfArM
mdprc 009 02 15 000Microtek Medical IncGamma Probe CoverBfArM
mdprc 119 01 15 000Stryker Instruments.Neptune 2 Rover Ultra Waste Management SystemBfArM
mdprc 110 01 15 000Siemens Medical SolutionsCTVision System in combination with syngo RT Therapist / syngo RT OncologistBfArM
mdprc 109 01 15 000Diagnostica Stagocrew Microtainer Reducers for STA-R / STA-R EvolutionBfArM
mdprc 108 01 15 000Christoph Miethke GmbH & Co. KGShuntassistentBfArM
mdprc 107 01 15 000Samsung ElectronicsXGEO GC80BfArM
mdprc 087 01 15 000Otto Bock Mobility SolutionsPower WheelchairsBfArM
mdprc 086 01 15 000BHT-Hygienetechnik GmbHINNOVA - E4 with 20.000.45 Pressure Chamber RackBfArM
mdprc 085 01 15 000B Braun Surgical SABiolox delta Insert Type G head diameter 36 mmBfArM
mdprc 140 04 14 001MAQUET IncOR-Table-System OTESUS 1160.01MHRA
mdprc 063 01 15 000MedicinaDS03 – DS06 Silo DressingBfArM
mdprc 062 01 15 000Hagsfelder Werkstätten und Wohngemeinschaften Karlsruhe gGmbHHWK therapy tables Solid, Novum, Novum Kingsize and Hippotherapy device with linear motors from the company Magnetic Elektromotoren AGBfArM
mdprc 061 01 15 000bemag Objekteinrichtungen AGCare BedsBfArM
mdprc 034 01 15 000Fresenius Kabi Ltd.FREKA CONNECT ENLockBfArM
mdprc 168 12 14 000Sutter Medizintechnik GmbHelectrode insert, grasping forceps, fenestrated (for Bison bipolar clamp)BfArM
mdprc 167 12 14 000Siemens Medical SolutionsDigital Linear Accelerators of type ARTISTEBfArM
mdprc 138 12 14 000Ulrich GmbH & Co. KGFrisbee cervical disc prosthesisBfArM
mdprc 137 12 14 000Owen MumfordInsulin Pen InjectorBfArM
mdprc 136 12 14 000Hansen Medical, Inc.Sensei X Robotic Catheter System (Sensei X System)BfArM
mdprc 127 12 14 000Owen MumfordInsulin Pen InjectorBfArM
mdprc 100 12 14 000Zimmer incPF Stem lateralized cemented size 8 and PF Stem Standard cemented Size 7BfArM
mdprc 099 12 14 000Siemens Medical SolutionsDigital Linear Accelerators of type MEVATRON™ and PRIMUS with Automatic Sequenced Treatment Delivery OptionBfArM
mdprc 098 12 14 000Roche Diagnostics LtdAccu-Chek Connect Diabetes Management AppBfArM
mdprc 097 12 14 000Philips Burtonrilliance CT series and other CT systemsBfArM
mdprc 096 12 14 000Mitsubishi Heavy Industries Ltd.VERO / MHI-TM2000 Linear Accelerator SystemBfArM
mdprc 095 12 14 000iMDsoft LtdMetaVision Suite, Clinical Information System version 5.4xBfArM
mdprc 089 12 14 000OculentisLENTIS HydroSmart foldable Intraocular lenses in glass vialsBfArM
mdprc 088 12 14 000SPIGGLE & THEIS MedizintechnikShaver Blades, straight/curved, single use and sterileBfArM
mdprc 087 12 14 000MAQUET Cardiovascular LLCCARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)BfArM
mdprc 086 12 14 000Arrow International IncARROW Continuous Nerve Block Needle.BfArM
mdprc 080 12 14 000KayserBetten GmbH & Co.KayserBett Olaf 85BfArM
mdprc 079 12 14 000PFM medical AGASEPT Pleural Catheter Kits and Peritoneal Catheter KitsBfArM
mdprc 078 12 14 000SIEMENSBiograph mCT- and Biograph mCT Flow systemsBfArM
mdprc 077 12 14 000Fluoron GmbHGas Tamponade EasyGas SF6BfArM
mdprc 072 12 14 000AAT Alber Antriebstechnikv-maxBfArM
mdprc 022 12 14 000SIEMENSMammography system Mammomat Inspiration/FusionBfArM
mdprc 021 12 14 000ConMed CorporationPadPro & R2 Multifunction ElectrodesBfArM
mdprc 020 12 14 000Christoph Miethke GmbH & Co. KGShunt assistantBfArM
mdprc 019 12 14 000B. Braun (Aesculap)ProSet Omnifix Syringe 5ml / 10mlBfArM
mdprc 099 11 14 000SIEMENSSyngo.plazaBfArM
mdprc 098 11 14 000SAM Medical ProductsAuxiliary StrapBfArM
mdprc 068 08 14 001Boston Scientific Cardiac Rhythm Management GroupLotus Valve SystemBfArM
mdprc 092 11 14 000Alcon Laboratories Inc.INFINITI Fluidic Management SystemsBfArM
mdprc 091 11 14 000Elekta LimitedMOSAIQBfArM
mdprc 090 11 14 000Fresenius Kabi Ltd.Ambix Intrastick Safe Y-Site and Ambix NONCORstick Safe Port CannulaeBfArM
mdprc 089 11 14 000SIEMENSIMMULITE_IMMULITE 1000 Turbo Troponin I _ LSKTI1BfArM
mdprc 088 11 14 000SIEMENSYsio Max, Luminos dRF Max and Luminos Agile Max with software version VE10 included SmartOrtho licenseBfArM
mdprc 004 10 14 001Smith & Nephew OrthopaedicRENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ)BfArM
mdprc 062 11 14 000Biotype Diagnostik GmbHMentype MycoDermBfArM
mdprc 035 11 14 001Discus Dental LLCRelief ACP Oral Care Gelhttp://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01166-1
mdprc 043 11 14 000Terumo Europe N.VHercules 360 Universal Stabilizing ArmBfArM
mdprc 042 11 14 000Smith & Nephew OrthopaedicLEGION COCR Constrained Femoral deviceBfArM
mdprc 041 11 14 000Medtronic MiniMedThe MiniMed Silhouette and Sure-T infusion setsBfArM
mdprc 040 11 14 000Dornier MedTech GmbHthe diode laser devices Medilas D12BfArM
mdprc 039 11 14 000Rocket MedicalRocket IPC Drainage BottleBfArM
mdprc 038 11 14 000Ranier Technology LimitedCadisc-L Total Disc Replacement DeviceBfArM
mdprc 037 11 14 000Heinen & LoewensteinLeoniPlusBfArM
mdprc 036 11 14 000GambroPrismaflex control unit used together with the PrismaLung KitBfArM
mdprc 034 11 14 000DiaSys Diagnostic Systems GmbHNEFA FSBfArM
mdprc 029 11 14 000D.O.R.C. Dutch Opthalmic Research Center (International) B.VMembraneBlue Dual Ophthalmic Surgical LiquidBfArM
mdprc 025 11 14 000Terumo BCT IncSpectra Optia Apheresis SystemsBfArM
mdprc 022 11 14 000Schiller AGMonitor– Defibrillator DEFIGARD 5000BfArM
mdprc 021 11 14 000Philips HealthcarePhilips IntelliVue Patient Monitors, Philips Avalon Fetal Monitors.BfArM
mdprc 020 11 14 000American Medical Systems, IncAMS 700 Accessory Kit - Lightning Bolt Keith NeedlesBfArM
mdprc 019 11 14 000Covidien LLCDAR Breathing System, Mapleson B and C configurationsBfArM
mdprc 134 10 14 000Stryker InstrumentsStryker Smartlife - Small and Large Aseptic HousingBfArM
mdprc 133 10 14 000Sage Products LLCComfort Shield Barrier Cream ClothsBfArM
mdprc 132 10 14 000Medacta International SAMectaLIF Oblique HandleBfArM
mdprc 131 10 14 000Gendex Dental SystemseXpert DC intraoral x-ray SystemBfArM
mdprc 130 10 14 000D.O.R.C. Dutch Opthalmic Research Center (International) B.VDisposable Associate Cartridge and Disposable High Speed Vitrectomy PackBfArM
mdprc 129 10 14 000Bard Access SystemsBard Dimension Stone BasketBfArM
mdprc 128 10 14 000B. Braun (Aesculap)Celsite Access PortsBfArM
mdprc 127 10 14 000American Medical Systems, IncAdVance XP Male Sling SystemsBfArM
mdprc 125 10 14 000Terumo Cardiovascular Systems CorporationTerumo Advanced Perfusion System 1 - Heart-Lung MachineBfArM
mdprc 124 10 14 000nal von minden GmbHSaliva Sample Collection Device Drug-Screen-Multi 6GA/6GC/6GD SalivaBfArM
mdprc 123 10 14 000Ethicon Inc A Johnson & Johnson CoEthicon Vicryl Mesh Bag deviceBfArM
mdprc 094 10 14 000Smith & Nephew OrthopaedicGENESIS II Saw BladesBfArM
mdprc 093 10 14 000Smith & Nephew OrthopaedicTRIGEN INTERTAN Lag Screw Length GaugeBfArM
mdprc 092 10 14 000Semperit Technische Produkte Gesellschaft m.b.H.Sempermed Supreme surgical glovesBfArM
mdprc 091 10 14 000IBA Dosimetry GmbHproduct Compass 3.1BfArM
mdprc 090 10 14 000CynosureElite XPL (Pulsed Light) Handpiece used with the MPX Laser SystemBfArM
mdprc 087 10 14 000MikrogenRecomWell Treponema IgM (Art.No. 5105) and ELISA Treponema Cutoff Control IgM (Art. Nr. 25161)BfArM
mdprc 003 10 14 001Siemens Healthcare DiagnosticsArtis zeego systems with a C-armBfArM
mdprc 064 10 14 000Waldemar LINK GmbH & CoEndo-Model SL – Connection ComponentBfArM
mdprc 063 10 14 000Stryker Instruments.Triathlon Tibial Alignment Ankle Clamp EM (Instrument)BfArM
mdprc 062 10 14 000Perouse MedicalDolphin Inflation device - Caliber Inflation DeviceBfArM
mdprc 061 10 14 000Bard Access SystemsSafe-Cut Safety Scalpels Contained in Peripherally Inserted Central Catheter and Dialysis Catheter KitsBfArM
mdprc 060 10 14 000Shenzhen MindrayBeneHeart D1 Defibrillator/MonitorBfArM
mdprc 059 10 14 000Philips Medical Systems Nederland B.V.Expression Information Portal (IP5)BfArM
mdprc 058 10 14 000Medtronic IncAscenda Intrathecal Catheters and Ascenda Revision Kits.BfArM
mdprc 057 10 14 000Cook MedicalSPIROTOME, biopsy instrumentsBfArM
mdprc 033 10 14 000SIEMENSYsio Max, Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max SystemsBfArM
mdprc 024 10 14 000Elekta Inceksell Gamma Knife Perfexion - stereotactic surgery systemBfArM
mdprc 023 10 14 000Boston ScientificOffRoad Re-Entry Catheter SystemBfArM
mdprc 002 10 14 000GE HealthcarePrecision 500D X-ray imaging systems with CRT monitor suspensionBfArM
mdprc 114 09 14 000Teleflex MedicalHudson RCI PaediatricAnaesthesia Breathing CircuitBfArM
mdprc 113 09 14 000Urotech GmbHGuide Wire SemislipBfArM
mdprc 112 09 14 000tantum AGEXTRON external wrist fixatorBfArM
mdprc 111 09 14 000SIEMENSStereo biopsy devices for MAMMOMAT Inspiration mammography systemsBfArM
mdprc 110 09 14 000Intuitive Surgical Incda Vinci Xi Surgical Systems - Patient CartsBfArM
mdprc 109 09 14 000aap Biomaterials GmbHVarioFit Classic (cemented)BfArM
mdprc 079 09 14 000Zimmer incAnterior/Supine Rasp HandlesBfArM
mdprc 077 09 14 000Ethicon Endo Surgery IncECHELON ENDOPATH Endoscopic Linear Cutter ReloadsBfArM
mdprc 074 09 14 000Zimmer incScrew-vent/Blank Screw vent/Abutment BlanksBfArM
mdprc 073 09 14 000Pega MedicalGAP Endo-Exo Medullary System / Nail DriverBfArM
mdprc 072 09 14 000Bemis Manufacturing CompanyBemis Hi-Flow Suction Canister LidsBfArM
mdprc 059 09 14 000Stryker Instruments.Triathlon Femoral, Scorpio Femoral, Restoration Wedge AugmentsBfArM
mdprc 058 09 14 000PromedonPromedonBfArM
mdprc 057 09 14 000Philips HealthcareM3516A BatteryBfArM
mdprc 033 09 14 000SIEMENSS and T Series camera systemsBfArM
mdprc 017 09 14 000Volcano CorpVolcano Trak Back II Disposable Pullback DeviceBfArM
mdprc 016 09 14 000Siemens Healthcare DiagnosticsCentraLink Data Management SystemBfArM
mdprc 015 09 14 000Rudolf Medical GmbH & Co. KGScherbak weights for the Scherbak vaginal speculaBfArM
mdprc 014 09 14 000Ethicon Endo Surgery IncPROXIMATE RH Rotating Head Skin Stapler, PROXIMATE Fixed Head Skin StaplerBfArM
mdprc 013 09 14 000Bayer Healthcare LLC..Spiroflex VG Thrombectomy Set for use with the AngioJet Ultra Thrombectomy SystemBfArM
mdprc 177 11 13 001Instrumentation LaboratoryHemosIL AcuStar HIT-Ab(PF4-H)BfArM
mdprc 141 08 14 000Teleflex Medical.Pilling Derra Anastomosis ClampBfArM
mdprc 140 08 14 000PAUL HARTMANNCotton-tipped applicators with polypropylene gripBfArM
mdprc 127 08 14 000Siemens Healthcare Diagnostics GmbHMicroScan® Microbiology Systems, MicroScan Dried Gram Negative MIC/ComboBfArM
mdprc 126 08 14 000Siemens Healthcare Diagnostics ProductIMMULITE 2000 and IMMULITE 2000 XPi MarjoramBfArM
mdprc 125 08 14 000Siemens Healthcare Diagnostics GmbHADVIA Chemistry A1c_3 CalibratorBfArM
mdprc 088 03 14 003i-Medical Ophthalmic International GmbHOphthalmological technology, i-Visc 1.0 BfArM
mdprc 112 08 14 000Gebrüder Martin GmbH & Co. KGScherbak weightsBfArM
mdprc 111 08 14 000Coherex Medical Inc.Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System and Delivery SheathBfArM
mdprc 110 08 14 000OrthodynamicsTibiagelenkteil, Pol-Endo – size small and medium / Femurgelenkteil, Pol-Endo – size smallBfArM
mdprc 109 08 14 000PINO GmbHPINOFIT Vertical-Cable-Pull-MachineBfArM
mdprc 108 08 14 000MAQUET IncOR table integration TEGRIS OR TABLE CONTROLBfArM
mdprc 084 08 14 000Maquet Cardiopulmonary AGVenous Bubble Trap VBT 160 and Custom Tubing Sets containing the Venous Bubble Trap VBT 160BfArM
mdprc 082 08 14 000Instrumentation LaboratoryClinical Chemistry Analyzer ILab Taurus SystemsBfArM
mdprc 069 08 14 000Cell Marque CorporationMouse Monoclonal AntibodyBfArM
mdprc 067 08 14 000Biomet IncCalcibonBfArM
mdprc 066 08 14 000C. R. Bard Inc.Temperature Simulator Keys used with Bard® ARTIC SUN® Temperature Management SystemBfArM
mdprc 065 08 14 000Getinge Disinfection ABWasher‐Disinfector of GETINGE Getinge 46‐Series (CM302) with PACS 300/350 controlBfArM
mdprc 051 08 14 001MedtronicGuardian® REAL-Time Monitors http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128937
mdprc 050 08 14 000GS Elektromedizinische Geräte G. Stemple GmbHcorpuls3 defibrillatorBfArM
mdprc 049 08 14 000Gambro Lundia ABUltrafilter U9000BfArM
mdprc 048 08 14 000Fresenius Kabi LtdAgilia Link+ device's connectivityBfArM
mdprc 047 08 14 000Depuy OrthopaedicsDePuy S‐ROM Noiles Rotating Hinge Femur with PinBfArM
mdprc 046 08 14 000American Medical Systems, IncAdVance® XP Male Sling SystemBfArM
mdprc 016 08 14 000Hitachi Medical CorpProSound F75BfArM
mdprc 015 08 14 000SPIGGLE & THEIS MedizintechnikPTFE Ventilation TubesBfArM
mdprc 014 08 14 000SIEMENSE.CAM Patient Handling System (PHS)BfArM
mdprc 013 08 14 000Wohlk-Contact-Linsen GmbHWeflex 55 W-50D; Sport Cantrast (Soft Contact Lenses)BfArM
mdprc 007 08 14 000Sorin Group.Sorin Heater Cooler DevicesBfArM
mdprc 006 08 14 000StrykerNail Insertion Sleeve, elastic T2 Tibia SPI Ø8-11 and Nail Insertion Sleeve, elastic T2 Tibia SPI Ø8-13BfArM
mdprc 005 08 14 000B. Braun (Aesculap)Dafilon BlueBfArM
mdprc 004 08 14 000PAUL HARTMANNCombiSets containing Ring Basin LinerBfArM
mdprc 105 07 14 000Zimmer incPERSONA The Personalized Knee System Tibial General Instrument Tray, Fixed BracketBfArM
mdprc 104 07 14 000Systagenix Wound ManagementTOPPER Xtra Absorbent Dressing PadsBfArM
mdprc 103 07 14 000Synthes IncXRL Medium Implant HolderBfArM
mdprc 102 07 14 000Salter LabsSalter Labs Oxygen MaskBfArM
mdprc 101 07 14 000Microtek Medical IncBasin LinerBfArM
mdprc 100 07 14 000Fresenius Kabi Ltd.AMIKA nutrition pumpBfArM
mdprc 099 07 14 000Aesculap IncE.Motion FP Meniscal component F5R 12mmBfArM
mdprc 083 07 14 000Ulrich GmbH & Co. KGAutomatic tourniquet “kariba”BfArM
mdprc 082 07 14 000St. Jude Medical Inc…Amplatzer Cardiac Plug (ACP)BfArM
mdprc 081 07 14 000Nucletron bvMicroSelectron and FlexitronBfArM
mdprc 080 07 14 000BrainLABExacTrac 6.0 Patient Positioning SystemBfArM
mdprc 079 07 14 000Biomet IncOlympia Stem size 2 RightBfArM
mdprc 062 07 14 000Origio A/SPasteur PipetsBfArM
mdprc 061 07 14 000Depuy Orthopaedics, IncRECLAIM Taper Protector InstrumentBfArM
mdprc 033 07 14 000Biolase Inc./Biolase Europe GmbHWaterlase iPlus Dental Laser SystemBfArM
mdprc 032 07 14 000Synthes IncMatrixRIB Fixation SystemBfArM
mdprc 031 07 14 000Carestream Health Inc Div Onex CorpKodak DirectView DR 9000 SystemsBfArM
mdprc 003 07 14 000GambroPRISMA, PRISMAFLEX, PRISMARS, X-MARS, ADSORBA, SEPTEX and OXIRIS setsBfArM
mdprc 002 07 14 000MEASUREMENT SPECIALTIES, INC.Measurement Specialties Reusable Temperature Probe Autoclavable – Esophageal / Rectal “ Adult, Pediatric, Skin (Adult) “BfArM
mdprc 001 07 14 000FertiliTechEmbryoScope time-lapse system.BfArM
mdprc 126 06 14 000SIEMENSSyngo RT Therapist and Syngo RT OncologistBfArM
mdprc 121 06 14 000Smith & Nephew OrthopaedicSUTUREFIX Ultra AnchorsBfArM
mdprc 120 06 14 000Siemens Healthcare DiagnosticsRAPIDPoint 500 Lactate CartridgesBfArM
mdprc 119 06 14 000FUJIFILM Medical SystemsFUJIFILM Digital Mammography System AMULET (FDR MS-1000) with Biopsy unitBfArM
mdprc 118 06 14 000BrainLABNavigation Software Spine & Trauma 3DBfArM
mdprc 117 06 14 000Amplitude GmbHCotyle double mobilité SATURNEBfArM
mdprc 092 06 14 000Bayer Healthcare LLC..JETSTREAM SC Atherectomy Catheter 1.85, JETSTREAM XC Atherectomy Catheter 2.4/3.4BfArM
mdprc 090 06 14 000Siemens Medical Solutionssyngo RT DosimetristBfArM
mdprc 089 06 14 000Siemens Healthcare Diagnostics GmbHMicroScanWalkAway SystemsBfArM
mdprc 088 06 14 000Sekisui Diagnostics LLC.RSV IgG/IgM ELISA, RSV IgM Control-SetBfArM
mdprc 087 06 14 000Mazor RoboticsRenaissance System Brain Application Skull Screws made of Titanium.BfArM
mdprc 086 06 14 000InstitutStraumannRN synOcta Abutment H2.5mmBfArM
mdprc 085 06 14 000Hologic IncAPTIMA Urine Collection KitBfArM
mdprc 084 06 14 000BrainLABExacTrac Vero 3.x Patient Positioning SystemBfArM
mdprc 066 06 14 000Biosense Webster Inc A Johnson & Johnson CoCordis RENLANE Renal Denervation CatheterBfArM
mdprc 007 06 14 000Draeger Medical Systems IncZEUS IE with integrated patient monitoringBfArM
mdprc 140 05 14 000Osypka Medical GmbHVACS II / VACS III – Valvuloplasty CathetersBfArM
mdprc 139 05 14 000Invacare CorporationFixed Backrest for Mobile Shower and Toilet CommodeBfArM
mdprc 138 05 14 000DIALAB GmbHDOA SALIVA MULTI-6 TESTBfArM
mdprc 137 05 14 000Biomet IncBiolox Delta Ceramic Head 36mm StandardBfArM
mdprc 129 05 14 000Smiths MedicalSnuggle Warm Sterile Cardiac Warming BlanketsBfArM
mdprc 128 05 14 000CardioKinetix IncPARACHUTE Delivery SystemBfArM
mdprc 127 05 14 000Berlin Heart AGproduct EXCOR Blood pumpBfArM
mdprc 117 05 14 000SIEMENSACUSON S Family ultrasound systemsBfArM
mdprc 116 05 14 000Naniwa Rubber Co LtdTubing set for Blood Purification.BfArM
mdprc 115 05 14 000KISCOL‐VARLOCK Instrument / Implant boxBfArM
mdprc 098 05 14 000AesculapMiethke Shunt System Ventricular CathetersBfArM
mdprc 058 05 14 000Arrow International IncPSI Kits, Multi-Lumen/PSI Kits and CVC/PSI KitsBfArM
mdprc 056 05 14 000B. Braun (Aesculap)Coroflex ISARBfArM
mdprc 041 05 14 000InnovaconSureStep One Step Drug Screen Test Device (Urine) Methadone 300BfArM
mdprc 040 05 14 000SIEMENSACUSON SC2000BfArM
mdprc 039 05 14 000SIEMENSACUSON SC2000BfArM
mdprc 038 05 14 000Smith & Nephew incRT-PLUS Femoral ComponentBfArM
mdprc 037 05 14 000SIEMENSsyngo Workflow MLR - "Portal Radiologist"BfArM
mdprc 036 05 14 000Redcord ASslings and straps with a D-RingBfArM
mdprc 035 05 14 000Philips HealthcareBrilliance CT 16, Brilliance CT 64, Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology, Brilliance iCT, Ingenuity CT, Ingenuity Core, Ingenuity Core 128 and Ingenuity FlexBfArM
mdprc 034 05 14 000NeoChord IncNeoChord DS1000 deviceBfArM
mdprc 033 05 14 000Invacare CorporationMobile Shower and Toilet Commode Aquatec Ocean VIPBfArM
mdprc 032 05 14 000BEGO Implant Systems GmbHDrill stops of RS/RSX-Line 3.0 from Drill stop TrayPlus RS/RSX-LineBfArM
mdprc 001 05 14 000ORGENTECAlegria® Anti-Intrinsic Factor assay (ORG 247-24)BfArM
mdprc 170 04 14 000GE HealthcarePatient Data Module (PDM)BfArM
mdprc 169 04 14 000SIEMENSSyngo Dynamics with Sensis integration licenceBfArM
mdprc 168 04 14 000GE HealthcarePatient Data Module (PDM)BfArM
mdprc 142 04 14 000Ranier Technology LimitedCadisc®-L Artificial Spinal DiscsBfArM
mdprc 141 04 14 000SIEMENSSIEMENS Luminos dRFBfArM
mdprc 139 04 14 000BrainLABExacTrac 5.5.5 Patient Positioning SystemBfArM
mdprc 134 04 14 000Otto Bock Mobility SolutionsA200 Power Wheelchair, Skippi / Skippi Plus Power Wheel chairBfArM
mdprc 133 04 14 000Biomet France SARLOptivac Knee NozzleBfArM
mdprc 132 04 14 000EOS ImagingsterEOS workstationBfArM
mdprc 097 04 14 000SIEMENSSOMATOM Emotion 6 Slice (DE), SOMATOM Emotion 16 Slice (DE)BfArM
mdprc 096 04 14 000SIEMENSACUSON X700 ultrasound systemsBfArM
mdprc 095 04 14 000BIOTRONIK Astron Pulsar Self-Expanding Nitinol Stent SystemBfArM
mdprc 076 03 14 001Pega MedicalFASSIER-DUVAL TELESCOPIC IM SYSTEMhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=126028
mdprc 079 04 14 000Translumina GmbHSterile-packed medical devicesBfArM
mdprc 078 04 14 000MedtechROSA™ deviceBfArM
mdprc 077 04 14 000MAQUET IncMAQUET Medical Ceiling Supply UnitsBfArM
mdprc 076 04 14 000Hygeia Medical Co. LtdSurgical bladeBfArM
mdprc 075 04 14 000B Braun Medical IncCavafix Certo and Cavafix Certodyn cathetersBfArM
mdprc 056 04 14 000SIMPIRICA SPINELimiFlex Paraspinous Tension BandBfArM
mdprc 055 04 14 000SIEMENSDigital Linear Accelerators of type MEVATRON, PRIMUS, ONCOR and ARTISTEBfArM
mdprc 054 04 14 000AOTI Ltd.AOTI Hyper-Box SystemBfArM
mdprc 027 04 14 000Medisize bvHeated Expiratory Limb 150cm NeonatalBfArM
mdprc 008 04 14 000Philips HealthcareIngenuity CoreBfArM
mdprc 007 04 14 000Handicare GmbHWing handles for ReTurn 7400 and 7500BfArM
mdprc 006 04 14 000VascoMedViaCath BfArM
mdprc 005 04 14 000IRIS DiagnosticsiChem Velocity Urine Chemistry StripsBfArM
mdprc 004 04 14 000Eckert & ZieglerFletcher LCT82, MS-AWS DB v3.2.0 D2 and lowerBfArM
mdprc 147 03 14 000Smiths Medical ASD Inc..Medex® Custom Kits Containing BD 300865 Plastipak 50 mL Luer Lock Syringe BfArM
mdprc 132 03 14 000Fresenius Kabi LtdBlood Bag Systems, COMPOFLOW, COMPOSTOP, COMPOFLEX and COMPOSELECTBfArM
mdprc 131 03 14 000B. Braun (Aesculap)Coroflex Blue NeoBfArM
mdprc 123 03 14 000Karl Storz GmbH & Co KGEquipment Carts and Isolation Transformers BfArM
mdprc 122 02 14 001SIEMENSsyngo Dynamics v9.5http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125718
mdprc 113 03 14 000Richard Wolf GmbHScissor blades 4393040 ModuBlade “MetzenbaumBfArM
mdprc 112 03 14 000Kimal plcKimal Procedure Packs containing Needle 18G x 7cm Sing Wall Cordis A4 BfArM
mdprc 111 03 14 000CooperVision Inc.Biomedics 1 Day Toric _ L53 - Biomedics 1 Day (55%) ToricBfArM
mdprc 103 03 14 000Karl Storz GmbH & Co KGDiamond-TwinS diamond cuttersBfArM
mdprc 102 03 14 000ConMed CorporationALTRUS® Thermal Tissue Fusion HandpiecesBfArM
mdprc 091 03 14 000SorinSterile INSPIRE Custom PackBfArM
mdprc 089 03 14 000SIEMENSUltrasound imaging system, ACUSON P300BfArM
mdprc 087 03 14 000GE HealthcareOptima CT580 or Discovery CT590RT scanner BfArM
mdprc 086 03 14 000DeVilbiss Healthcare LLCCompact Oxygen Concentrators BfArM
mdprc 077 03 14 000Human GmbhHexagon PSABfArM
mdprc 074 03 14 000Draeger Medical IncDevapor VaporizersBfArM
mdprc 049 03 14 000Lohmann & Rauscher InternationalSetpack Toptex lite X-ray detectable Laparotomy SwabBfArM
mdprc 015 03 14 000SORG RollstuhltechnikWheelchair models VectorBfArM
mdprc 014 03 14 000Richard Wolf GmbHEquipment cart RIWOmobilBfArM
mdprc 123 02 14 001Hologic IncNovaSure Radiofrequency Control Unithttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=125361
mdprc 032 02 14 001DePuy International LtdPFC® SIGMA Cruciate Retaining (CR) Cemented FemoralBfArM
mdprc 162 02 14 000Depuy Orthopaedics, IncDePuy CMW 2 Gentamicin Bone CementBfArM
mdprc 161 02 14 000KISCOL-VARLOCK cage / trial implant holder BfArM
mdprc 159 02 14 000Fresenius Kabi LtdFreka Intestinal Tube ENLockBfArM
mdprc 158 02 14 000ACRA-CUT Inc.Reusable Cranial Perforators BfArM
mdprc 157 02 14 000Synthes IncCortex Screw diameter 4.5 mm, self-tapp., L 44+46 mm, SStBfArM
mdprc 126 02 14 000Micro-Tech Europe GmbHSpiked Biopsy Forceps BfArM
mdprc 121 02 14 000Hitachi Medical Corp-Whole Body X-ray CT System ECLOS and Hyper Quick Net
-Whole Body X-ray CT System SCENARIA and Hyper Q-Net S
BfArM
mdprc 092 02 14 000MEDEXmanyfill filling injection kitsBfArM
mdprc 088 02 14 000Smith & Nephew OrthopaedicDYONICS 25 Patient Tube Set BfArM
mdprc 145 02 13 001Calhoun Vision Inc.The Light Delivery Device used to adjust dioptric power of the company’s Light Adjustable Lens , LDD systemBfArM
mdprc 083 02 14 000ACON Laboratories Inc.ACON On Call Advanced Blood Glucose Monitoring SystemBfArM
mdprc 082 02 14 000GS Elektromedizinische Geräte G. Stemple GmbHDefibrillator/pacer SLIM unit, Corpuls 3 systemBfArM
mdprc 081 02 14 000Nikkiso Europe GmbH.Hemofiltration Device AQUARIUSBfArM
mdprc 080 02 14 000ASICO LLCASICO ROYAL UNIHAND INJECTORBfArM
mdprc 079 02 14 000Temmler PharmaAcetocaustin PenBfArM
mdprc 075 02 14 000Willmann & Pein GmbHCompetence FlowBfArM
mdprc 047 02 14 000Stryker Howmedica Osteonics CorpNavigation Compatible Accolade Broach HandleBfArM
mdprc 008 02 14 001Rayner Intraocular Lenses LtdM-flex Intracular LensBfArM
mdprc 010 02 14 000Thermo Fisher Scientific Inc.Estrogen Receptor AB11BfArM
mdprc 009 02 14 000Standard DignosticsSD Bioline TetanusBfArM
mdprc 007 02 14 000BD Diagnostic SystemsBBL Staphyloslide™ Latex Test KitBfArM
mdprc 006 02 14 000bioMerieuxIncbioNexiaFOBplusBfArM
mdprc 005 02 14 000Cardiac Science CorporationPowerheart G5 Automatic External Defibrillators (AEDs)BfArM
mdprc 101 01 14 000B Braun Surgical SAsurgical suture MONOPLUS VIOLET o (3.5) 90 cm HR40S (M)BfArM
mdprc 090 01 14 000Thermo Fisher Scientific OyIndiko and Indiko Plus analyzersBfArM
mdprc 089 01 14 000Sysmex Europe GmbH.Lynoamp® BC, Lynoamp® BC HTS and Lynoamp® CCBfArM
mdprc 088 01 14 000Baxter HealthcareAdaptateur pour Flacon IsopackBfArM
mdprc 085 01 14 000ThermoFisher Scientific Microbiology PerthCampylobacter CCDA selective mediumBfArM
mdprc 074 01 14 000Human GmbhHbA1c liquidirectBfArM
mdprc 073 01 14 000ERBE Elektromedizin GmbHLaparoscopic BiClamp handlesBfArM
mdprc 066 01 14 000Hain Lifescience GmbHAnalyzer 1.1.1 of the FluoroType MRSA KitBfArM
mdprc 053 12 11 001Teleflex MedicalSengstaken tubes and correlating guide wiresBfArM
mdprc 065 01 14 000Greiner Bio-One IncVacuette 2 ml Glucomedics TubesBfArM
mdprc 056 01 14 000Codan Argus AGA707V / A708VBfArM
mdprc 055 01 14 000Hitachi Medical CorpEchelon / ECHELON OVAL / OASIS MRI SystemsBfArM
mdprc 054 01 14 000Likamed GmbHNOVO X 550BfArM
mdprc 053 01 14 000ArthroCare CorporationSuper MultiVac 50 Coblation WandsBfArM
mdprc 044 01 14 000Philips HealthcareGemini TF Big Bore Positron Emission Tomography and Computed Tomography Systems BfArM
mdprc 043 01 14 000Nihon Kohden CorpBedside Monitors series, Life Scope J" BSM-9101K using the software version 13-05BfArM
mdprc 042 01 14 000Fisher & Paykel Healthcare Inc400HC212: HC431 NIV Elbows Non-Vented & Vented
400HC214: HC452 NIV Elbow Non-Vented & Vented
BfArM
mdprc 028 01 14 000Fresenius Kabi Ltd.Pump, AMIKA device.BfArM
mdprc 012 01 14 000Carl Zeiss Meditec IncLens, AT LISA 809MPBfArM
mdprc 157 12 13 000Beckman CoulterAccess 2 and UniCel Dxl Imunoassay SystemsBfArM
mdprc 156 12 13 000Carl Zeiss - Micro Imaging MicroscopesCompensator Slider Lambda 6x20BfArM
mdprc 144 12 13 000Berlin Heart AGIncor® Control UnitBfArM
mdprc 143 12 13 000Micropoint BiotechnologiesqLabs® PT-INR Q-1 Pro Test Systems and Q-1 Self TestBfArM
mdprc 135 12 13 000TerumoBCTTrima Accel Automated Blood Collection System.BfArM
mdprc 134 12 13 000Sooil DevelopmentInsulin pumps DANA Diabecare IIS.BfArM
mdprc 132 12 13 000SIEMENSArtis biplane system, radiological equipment for vascular diagnostics, x-ray imagingBfArM
mdprc 126 12 13 000OrthofixFirebird Spinal Fixation System.BfArM
mdprc 115 02 13 001Ranier Technology LimitedDistractors, Surgical, The Cadisc™-C Endplate Handles and BladesBfArM
mdprc 109 12 13 000Stryker OrthopaedicsTACTYS – PIP prosthesisBfArM
mdprc 108 12 13 000PTWNOMEX MultimeterBfArM
mdprc 107 12 13 000aap Biomaterials GmbHCannulated Screw 3.5 BfArM
mdprc 106 12 13 000ObalonObalon Inflation SystemsBfArM
mdprc 105 12 13 000TEM Innovations GmbHReagent r ex-tem (503-05) in EXTEM and APTEM assay.BfArM
mdprc 104 12 13 000BonesupportCerament Spine SupportBfArM
mdprc 094 12 13 000Smith & Nephew incREFLECTION Polyethylene Acetabular LinersBfArM
mdprc 093 12 13 000Medtronic IncModel 8870 Software Application Card used in the 8840 N’Vision™ Clinician ProgrammerBfArM
mdprc 092 12 13 000Sirona Dental Systems GmbHDental, patient chairs TENEOBfArM
mdprc 091 12 13 000Smiths MedicalMedex Angiographic-Puncture NeedlesBfArM
mdprc 070 12 13 000Lohmann & Rauscher InternationalSetpack® Toptex® lite X-ray detectable Laparotomy Swab, sterile, white, 4-layered, 40 x 40 cmBfArM
mdprc 033 11 13 001Siemens Medical SolutionsDigital Linear Accelerators of type ONCOR and ARTISTEBfArM
mdprc 045 12 13 000Siemens Healthcare DiagnosticsCentraLink™ Data Management SystemBfArM
mdprc 044 12 13 000Siemens Medical SolutionsArtis Q systemsBfArM
mdprc 037 12 13 000Molnlycke Health CareCarotis SetsBfArM
mdprc 007 12 13 000Stryker Howmedica Osteonics CorpDekompressor Percutaneous Discectomy ProbeBfArM
mdprc 113 05 13 002Maquet Cardiopulmonary AGPediatric Arterial Cannula 10FBfArM
mdprc 178 11 13 000Nihon Kohden CorpCentral Monitor CNS-6201 seriesBfArM
mdprc 168 11 13 000Covidien LLCArgyle Single-Lumen Polyurethane Umbilical Vessel CathetersBfArM
mdprc 167 11 13 000B Braun Medical IncSyringes, Original-Perfusor Syringes 50 ml without cannulaBfArM
mdprc 166 11 13 000B Braun Medical IncIntrafix Primeline / Intrafix Air P setsBfArM
mdprc 144 11 13 000Ultradent Products, IncOpalescence Treswhite SupremeBfArM
mdprc 139 11 13 001Dimeda lnstrumente GmbhDEBAKEY Vascular DilatorsBfArM
mdprc 138 11 13 000Lohmann & Rauscher InternationalCellacast Soft Semi-rigid Casting TapeBfArM
mdprc 137 11 13 000OrthofixAzure Anterior Cervical PlatesBfArM
mdprc 093 11 13 000Draeger Medical Systems IncInfinity Acute Care System (IACS)BfArM
mdprc 092 11 13 000Miltenyi Biotec GmbHLIFE 18 apheresis systemBfArM
mdprc 091 11 13 000Draeger Medical Systems IncInfinity Acute Care System (IACS)BfArM
mdprc 067 11 13 000MetranDiaphragm Chambers concerning Metran Visionα/R100 High Frequency VentilatorsBfArM
mdprc 047 11 13 000bioMerieux IncBacT/ALERT® FA PLUS Culture BottleBfArM
mdprc 032 11 13 000Waldemar LINK GmbH & CoPE plateau of the Gemini SL Total Knee ReplacementBfArM
mdprc 031 11 13 000PARIinhalation devices Pari Sole N and Pari Sole N TracheoBfArM
mdprc 029 11 13 001B Braun Medical Incstopcocks, Discofix CBfArM
mdprc 027 11 13 000DIALABIVD, Calcium CPC FSBfArM
mdprc 026 11 13 000Thermo Fisher DiagnosticsIVDs, bacteriology assay kit immunoassay, Oxoid Antimicrobial Susceptibility Testing DiscsBfArM
mdprc 169 10 13 001Weinmann..Meducore Standard Defibrillator Monitoring SystemBfArM
mdprc 144 10 13 000SERAG-WIESSNER GmbHSurgical sutures, Seraflex, Supramid and Terylene.BfArM
mdprc 143 10 13 000Novacare GmbHProLift S222 Standsupport SlingsBfArM
mdprc 142 10 13 000Aesculap IncGA508R AIR HOSE ADAPTER ANGLED F/AESCULAP SMALLBfArM
mdprc 137 10 13 000Siemens Healthcare Diagnostics GmbHDimension Vista HCYS Flex reagent cartridge.BfArM
mdprc 136 10 13 000LAP GmbH Laser Applikationenlaser systems DORADOBfArM
mdprc 091 10 13 000Beckman CoulterIVD , UniCel DxC 600i Synchron Access Clinical SystemsBfArM
mdprc 090 10 13 000B. Braun (Aesculap)Insertation Instrument ME020RBfArM
mdprc 017 10 13 000WILAmedSurgical equipment, Anaesthesia, disposable breathing circuitBfArM
mdprc 020 08 13 001Siemens Medical Solutionsimaging systems, Digital Linear Accelerators PRIMUS, ONCOR and ARTISTEBfArM
mdprc 015 10 13 000ImmucorGamma BeneluxRed Cell Genotyping, IVD, RHD BeadChip KitBfArM
mdprc 118 09 13 000Teleflex Medical..Injection, Infusion, Transfusion, Dialysis, SelfCat set "Travel"BfArM
mdprc 117 09 13 000Astute MedicalIn-vitro diagnostics, NephroCheck Liquid ControlBfArM
mdprc 108 09 13 000Invacare CorporationShower and toilet chair Aquatec Ocean VIP, Aquatec Ocean VIP XL, Aquatec Ocean Dual VIP, Aquatec Ocean E-VIPBfArM
mdprc 107 09 13 000Acufirm Ernst Kartz Gmbh.ACUFIRM surgical suturesBfArM
mdprc 098 09 13 000Fresenius Medical CareproVencare accessory “J-tipped safety guidewires“,BfArM
mdprc 055 09 13 000Siemens Healthcare Diagnostics IncMicroscan® Microbiology Systems regarding Microscan Synergies plus® and rapID/S plus Gram Negative PanelsBfArM
mdprc 044 09 13 000Medicel AGVISCOJECT-BIO 1.8 SINGLE-USE CARTRIDGE SETS, STERILEBfArM
mdprc 043 09 13 000Horiba ABX SASIVD, ABX PENTRA CALCIUM CPBfArM
mdprc 037 09 13 000SynCardia Systems IncImplant, SynCardia temporary Total Artificial Heart (TAH-t) with Bi-leaflet ValvesBfArM
mdprc 009 09 13 000Stryker OrthopaedicsH. Seidel Plug, 10mm DIABfArM
mdprc 003 09 13 000Medset Medizintechnik GmbHMedical electronics / Electromedical devices, Padsy Flashlight ErgoBfArM
mdprc 001 09 13 000Siemens Healthcare DiagnosticsIVDs, Advia Centaur Folate AssayBfArM
mdprc 171 08 13 000Radiometer MedicalLaboratory, Immunoassay, AQT90 FLEX AnalyzersBfArM
mdprc 170 08 13 000Corin Group plcAlphafit proximally modified stemBfArM
mdprc 168 08 13 000FUJIFILM Medical SystemsFine Needle Aspiration Ultrasound EndoscopesBfArM
mdprc 163 08 13 000StrykerImplants, HydroSet Injectable HA Bone SubstituteBfArM
mdprc 149 08 13 000DiaSys Diagnostic Systems GmbHIVD, Calcium CPC FSBfArM
mdprc 148 08 13 000B Braun Medical Inc.Injection/ Infusion/ Transfusion/Dialysis/ dialysis blood tubing system.BfArM
mdprc 147 08 13 000One Lambda IncIVD, HLA Fusion-SoftwareBfArM
mdprc 131 02 13 001Beckman Coulter IncGLUCOSE (GLU) cartridge assay. Synchron Systems LX®20 & UniCel DxC Systems onlyGLU ReagentBfArM
mdprc 124 08 13 000Maquet Cardiopulmonary AGOxygenators, VKMO 30000 (Quadrox -i Pediatric HMO 30000 + VHK 31000),BfArM
mdprc 058 08 13 001axicorp PharmaGlucoMen LX Sensor test stripsBfArM
mdprc 123 08 13 000Epigenomics AGEpi proColon 2.0 CEBfArM
mdprc 035 05 13 004Molnlycke Health CareInjection devices , BD 50ml syringes (within Molnlycke Procedure Pak®)BfArM
mdprc 081 08 13 000Sorin GroupAortic Cannulae and Retrograde Cardioplegia Cannulae, A sterile, rigid or semi-rigid tube that is surgically inserted into the aortaBfArM
mdprc 080 08 13 000Elekta IncMonaco RTP System, Radiobiological Planning for IMRT, VMAT and SBRTBfArM
mdprc 079 08 13 000Zimmer inctherapy laser system type OptonProBfArM
mdprc 059 08 13 000Sarstedt AG & Co.Blood Collection System, S-Monovette Lithium-HeparinBfArM
mdprc 057 08 13 000Siemens Healthcare DiagnosticsCalibrators - Immunochemistry , ADVIA Centaur Systems Calibrator ABfArM
mdprc 056 08 13 000Richard Wolf GmbHFiber Ureterorenoscope „E-Line“ and Operating Fiber Ureterorenoscope „E-Line“BfArM
mdprc 042 08 13 000circuliteSYNERGY® Circulatory Support SystemBfArM
mdprc 041 08 13 000Edwards LifesciencesCannulae, Arterial, EndoReturn Arterial CannulaeBfArM
mdprc 022 08 13 000International Technidyne CorporationLow Range Activated Clotting Time (ACT-LR) CuvettesBfArM
mdprc 021 08 13 000Ulrich GmbH & Co. KGcerv-X, Cervical CageBfArM
mdprc 016 08 13 000ImmucorGamma BeneluxIVDs, RHD BeadChip Kit Master LotBfArM
mdprc 014 08 13 000Trumpf Medical Systems, Inc.General equipment for medical treatment , ORBITER patient transfer systemBfArM
mdprc 013 08 13 000Siemens Healthcare Diagnostics ProductIVDs, Advia Centaur / Advia Centaur XP and Advia Centaur CP HCY Diluent, Calibrator 88 and HomocysteineBfArM
mdprc 011 08 13 000BEGO Implant Systems GmbHImplants, BEGO Semados® S4,1 L10BfArM
mdprc 010 08 13 000DiaSorin IncIVDs, ETI ANA/ENA 8 Profile, AutoimmunityBfArM
mdprc 009 08 13 000DiaSorin IncIVDs, ETI dsDNABfArM
mdprc 008 08 13 000Bio-Rad Laboratories IncIVDs, Serotonin by HPLC Calibrator Set, BioradBfArM
mdprc 187 07 13 000MikrogenIVD, recomLine Parvovirus B19 IgM and recomLine Parvovirus B19 IgGBfArM
mdprc 186 07 13 000SYMETISImplants, Acurate TA™ Transapical Aortic BioprosthesisBfArM
mdprc 185 07 13 000CuretisIVD, Unyvero Pneumonia SetsBfArM
mdprc 176 07 13 000Stryker OrthopaedicsTriathlon Size 3-6 PS Femoral & Tibial Trialing Lower TrayBfArM
mdprc 173 07 13 000OptiMed Medizinische Instrumente GmbHVascular stent system, Intravascular Treatment, sinus-XL StentBfArM
mdprc 172 07 13 000Maquet Cardiopulmonary AGMulti-therapy heart-lung assist system, BE-ECLS 2.8 SetBfArM
mdprc 153 07 13 000Frankenman International LimitedCHEX Single Use Circular Stapler for Rectal Prolapse or HaemorrhoidsBfArM
mdprc 152 07 13 000Nihon Kohden CorpTelemetry Systems WEP-5204K, WEP-5208K using Software Version ≤ 03-10BfArM
mdprc 151 07 13 000Philips Respironics CaliforniaV60 Ventilator, V60 Power Management Board AssemblyBfArM
mdprc 141 07 13 000InnovaconFSH One Step Menopause Test Device (Urine) Package InsertBfArM
mdprc 140 07 13 000Smith & Nephew OrthopaedicImplants, GENESIS II Cruciate Retaining Insert Trials Size 3-4 9mmBfArM
mdprc 127 07 13 000ORGENTECIVD, Alegria Anti-Intrinsic Factor AssayBfArM
mdprc 126 07 13 000SIEMENSData management system, syngo® Lab Data ManagerBfArM
mdprc 045 07 13 001Belmont Instrument Corpblood transfusion, Belmont Rapid InfuserBfArM
mdprc 110 07 13 000GambroCatheters and Vessel Dilators, GamCathBfArM
mdprc 109 07 13 000Becton Dickinson & Co. (BD)Flashback Blood Collection needle, BD VacutainerBfArM
mdprc 107 07 13 000Hartmann USA, IncInjection devices , BD 50ml syringes (within HARTMANN Foliodrape Combi Sets)BfArM
mdprc 106 07 13 000Stryker Osteosynthesis Intramedullary SolutionsAsnis III Cannulated ScrewsBfArM
mdprc 078 07 13 000SIEMENSAnalyzer, multi-wavelength scanning and sample liquid-sensing technologies, Sysmex® CS-2000i SystemsSiemens Medical Solutions, Riyadh, (011) 277-8111
mdprc 069 07 13 000Ulrich GmbH & Co. KGspinal implant system, tangoRS rodsBfArM
mdprc 068 07 13 000ThermoFisher ScientificDetermination of uric acid concentration in human serum, Uric Acid AOXBfArM
mdprc 067 07 13 000StrykerIntracranial stent, Neuroform 3™ Microdelivery Stent SystemBfArM
mdprc 049 07 13 000ThermoFisher ScientificQMS Teicoplanin ReagentBfArM
mdprc 048 07 13 000PhotoMedexPhotoMedexBfArM
mdprc 047 07 13 000MAQUET IncPatient Transporter, TRANSLIFEBfArM
mdprc 046 07 13 000ImTheraAura6000-THN sleep therapy systemBfArM
mdprc 030 07 13 000Hill RomSiderail Spare Parts Kits for Model LI156 Evolution BedsBfArM
mdprc 006 07 13 000ThermoFisher ScientificPhadia 2500 EliA Instrument and Phadia 5000 EliA instrumentBfArM
mdprc 005 07 13 000MieleSterilizers, Miele washer disinfectorBfArM
mdprc 004 07 13 000Medline Industries IncCustom Sterile Packs containing BD Plastipak™ 50ml Luer LokBfArM
mdprc 003 07 13 000MedComSoftware, Radiotherapy Systems, VeriSuite 1.8BfArM
mdprc 002 07 13 000Kimal plcKimal procedure packs containing BD Plastipak 50ml LuerLok syringeBfArM
mdprc 001 07 13 000AesculapT-Space PEEK Facelift ImplantsBfArM
mdprc 118 06 13 000Zimmer incShoulder Retractors, Bigliani/Flatow® Fukuda RetractorsBfArM
mdprc 117 06 13 000Beckman Coulter IncAnalyzer , laboratory, AU2700 and AU5400 Clinical Chemistry AnalyzersBfArM
mdprc 116 06 13 000Medtronic IncLauncher® Coronary Guide CatheterBfArM
mdprc 115 06 13 000B Braun Medical Incsynthetic absorbable sterile surgical suture, suture Safil QuickBfArM
mdprc 105 06 13 000B Braun Medical Incsurgical sutures, LINO and DILENEBfArM
mdprc 104 06 13 000AlereIVD, Panbio Dengur IgM Capture ELISABfArM
mdprc 103 06 13 000Inomed MedizintechnikCT Planning System, Praezis Plus 3BfArM
mdprc 102 06 13 000Arrow International IncVenous Catheterization Kit, Arrow Central Venous Catheter KitsBfArM
mdprc 101 06 13 000Smith & Nephew OrthopaedicOrthopaedics, R3™ XLPE Acetabular Liner 36 mm ID X OD 60 mm 20° and one lot of R3™ XLPE Acetabular Liner 36 mm ID X OD 62 mm 20°BfArM
mdprc 088 06 13 000SIEMENSRadiation therapy, ARTISTE with syngo RT TherapistBfArM
mdprc 087 06 13 000Maquet Cardiopulmonary AGOxygenator, QUADROX-i(D) OxygenatorBfArM
mdprc 085 06 13 000WHITEsmile GmbHTooth whitening device, WHITEsmile HOME WHITENINGBfArM
mdprc 084 06 13 000Hill RomElectric Bed, Hill-Rom® 900 Electric Bed—Optional Bed Frame ExtensionBfArM
mdprc 083 06 13 000DePuy International LimitedOrthopaedic bone wire , KirschnerBfArM
mdprc 088 05 13 001Memmert GmbH und Co KGHeating ovens, Memmert UF450plus, UF750plus, IF750plusBfArM
mdprc 082 06 13 000Applied Medical ResourcesGelPOINT Advanced Access Platform, LaparoscopicBfArM
mdprc 066 06 13 000Smiths MedicalCustom kits containing BD 300865 Plastipak 50 mL Luer Lock SyringeBfArM
mdprc 029 04 13 001Berchtold CorpTables, Operating, Hand pendants for OPERON D 850, D 820 and D 760 operating tables.BfArM
mdprc 040 06 13 000Greiner Bio-One IncVarious Safety Blood Collection SetsBfArM
mdprc 039 06 13 000Siemens Medical SolutionsLinear accelerator systems, COHERENCE RT TherapistBfArM
mdprc 038 06 13 000Kimberly Clark Health Careprocedure trays, cuctom procedure traysBfArM
mdprc 036 06 13 000BrainLABCranial Navigation System, iMRI Registration MatrixBfArM
mdprc 035 06 13 000GE HealthcareServers, Image Diagnost (IDI) Collaboration ServerBfArM
mdprc 034 06 13 000Schwarzer GmbHIntracardiac catheter measuring stations, Schwarzer evoBfArM
mdprc 033 06 13 000Nobel BiocareAbutments, Procera abutment Ti for Astra Tech 4,5/5,0 STBfArM
mdprc 032 06 13 000M.E.D. Medical Products GmbHProcedure Packs, Supor FilterBfArM
mdprc 142 06 12 002Stryker OrthopaedicsProstheses, ABGII Modular and Rejuvenate Modular SystemsBfArM
mdprc 004 06 13 000DePuySynthesOrthopaedic cutting tools, Burr Attachments M and LBfArM
mdprc 003 06 13 000SIEMENSDigital Linear Accelerators, PRIMUS™ and ONCOR™ - Control ConsoleBfArM
mdprc 002 06 13 000Origio A/SOrigio Pasteur PipetsBfArM
mdprc 001 06 13 000Alere LTDIVD,BGEM Test Cards Used with epoc Blood Analysis Systems.BfArM
mdprc 090 05 13 000Hirtz & Co. KGPatient warming system, HICO-Aquatherm 660BfArM
mdprc 087 05 13 000Philips HealthcareX-ray system, DuraDiagnostBfArM
mdprc 086 05 13 000SPIGGLE & THEIS MedizintechnikInflation device Ref : 2080-9030020BfArM
mdprc 085 05 13 000B Braun Medical IncStopcocks, Discofix CBfArM
mdprc 084 05 13 000Heinz Kurz GmbHNasal Dilator (Brusis method)BfArM
mdprc 108 04 13 002Joline GmbHDialysis Catheters , Joline Acute Dialysis CathetersBfArM
mdprc 065 05 13 000CooperSurgical IncPessaries, Various Milex PessariesBfArM
mdprc 064 05 13 000Mitsubishi Chemical Medience CorporationLaboratory analysers, PATHFAST ImmunoanalyserBfArM
mdprc 039 05 13 000ConMed Linvatec CorporationImage capture system, VP1600 Still Capture SystemBfArM
mdprc 038 05 13 000Siemens Medical SolutionsARTISTE syngo RT Therapist (RTT),RadiationBfArM
mdprc 036 05 13 000ThermoFisher ScientificIVDs, bacteriology, Legionella GVPC Selective MediumBfArM
mdprc 034 05 13 000Nutricia Medical DevicesInjection / Infusion/ Transfusion/Dialysis, enteral feeding pumps Flocare® Infinity™BfArM
mdprc 033 05 13 000Trumpf Medical Systems, Inc.Lights, Surgical, HELION S examination light , Spring arm Acrobat SwingBfArM
mdprc 032 05 13 000PerkinElmer Life and Analytical SciencesInformation Systems, Data Management, Laboratory, LifeCycle for Prenatal Screening SoftwareBfArM
mdprc 031 05 13 000Beldico SASingle use sterile feeding bottles, ETO sterilizationBfArM
mdprc 178 02 13 001BioMerieux IncIVDs, Fibrinogen/fibrin degradation products assay, VIDAS D-Dimer ExclusionBfArM
mdprc 143 04 13 000Siemens Healthcare Diagnostics GmbHIVD , Microbiology Systems ,MicroScanBfArM
mdprc 142 04 13 000Roche Diagnostics LtdIVD , Glass syringe barrel , MODULAR ANALYTICS EVOBfArM
mdprc 141 04 13 000HyaltechOphthalmic Viscosurgical Devices: Z Hyalin Multipack ,BfArM
mdprc 140 04 13 000Gebrueder Martin GmbH & Co KG A KLS Martin Group CoSurgical equipment , Anaesthesia , KLS Martin Double-TFT monitor support arm systemBfArM
mdprc 139 04 13 000B Braun Medical IncInjection, Infusion, Transfusion/Dialysis , Perfusor compact infusion pumpsBfArM
mdprc 138 04 13 000AERIS THERAPEUTICSNon surgical lung volume reduction , AeriSeal SystemBfArM
mdprc 122 04 13 000Advanced Sterilization ProductsSterilizing Units, Plasma, Sterrad 100S CassetteBfArm
mdprc 121 04 13 000ArcRoyal LtdCustom procedure tray ( CPT), syringeBfArM
mdprc 019 03 13 001Ethicon Inc A Johnson & Johnson CoMesh, Polymeric, Various Mesh and Suture ProductsBfArM
mdprc 120 04 13 000Urovision GmbHInjection , Infusion , Dialysis , Renovision-Nephrostomy-SetsBfArM
mdprc 119 04 13 000Siemens Medical SolutionsTransducer , ultrasound system , SC2000BfArM
mdprc 118 04 13 000Siemens Medical SolutionsRadiological technology , Pacs , SYNGOBfArM
mdprc 117 04 13 000Philips HealthcareMonitors, IntelliVue Information iX Center SystemsBfArM
mdprc 116 04 13 000Bio-Detek IncorporatedMedsolutions4U Multi-Function Electrodes for Lifepak defibrillatorBfArM
mdprc 115 04 13 000Synthes IncOrthopaedic bone screw, non-bioabsorbable, sterile, DHS/DCS ScrewBfArM
mdprc 114 04 13 000Alcon Grieshaber AGConstellation® Pneumatic HandpieceBfArM
mdprc 111 04 13 000BrainLABStereotactic Systems, Image-Guided, Surgical, Orthopedic, StarLock Instrument AdaptersBfArM
mdprc 110 04 13 000FUJIFILM Medical SystemsRadiographic Systems, Digital, Mammographic, Model FDR MS-2500 AMULET f Digital Mammography SystemsBfArM
mdprc 109 04 13 000Intact VascularCatheter , implants , Tack-IT Endovascular Stapler SystemBfArM
mdprc 105 04 13 000Neusoft Medical SystemsCT , Scanner , NeuViz 16 CT systemsBfArM
mdprc 147 02 13 001Immucor GmbHIVDs, blood transfusion instrumentation , Capture PBfArM
mdprc 031 04 13 000Hospira IncInfusion Pumps, Analgesic, Patient-Controlled, LifeCare 4200 PCA Infusion SystemBfArM
mdprc 030 04 13 000P J Dahlhausen & CoTrocars, Trocar catheter.BfArM
mdprc 028 04 13 000ImplantcastProstheses, Joint, Knee, Mutars knee system, MUTARS® tibial plateau MUTARS® M-O-M and tibial plateau modular.BfArM
mdprc 158 03 13 000AMS USAPumps, AMS 800® Urinary Control SystemBfArM
mdprc 108 03 13 000Stryker OrthopaedicsOrthopedic manual surgical instrument , Triathlon Baseplate Impactor ExtractorBfArM
mdprc 107 03 13 000Gebrüder Martin GmbH & Co. KGDilatator, De BakeyBfArM
mdprc 106 03 13 000Biomet IncOrthopedic , surgical instruments .RINGLOC RIMCUP METAL COMPONENT 48mm - POROUS COATED+HABfArM
mdprc 123 06 12 001Hill Rom IncBeds, Dynamis and Gerialit BedsBfArM
mdprc 105 03 13 000AKS GmbhPatient hoist ,electric drives, Aks-clino IIBfArM
mdprc 104 03 13 000ThermoFisher ScientificIVD , Imunoassay Analyzers , Phadia 2500 / 5000BfArM
mdprc 103 03 13 000Terumo Cardiovascular Systems CorporationRoller pump , Advanced Perfusion System 1BfArM
mdprc 102 03 13 000Siemens Medical SolutionsImage archiving and information , Syngo PlazaBfArM
mdprc 101 03 13 000Richard Wolf GmbHInsufflators , Single used insufflations tubeBfArM
mdprc 070 03 13 000Posey CoRestraints, Biothane Ankle Wrist Restraint CuffsBfArM
mdprc 050 03 13 000Waldemar LINK GmbH & CoProstheses, Joint, Knee , Augments- CombiCup R® SystemBfArM
mdprc 049 03 13 000Siemens Medical SolutionsRadiographic/Fluoroscopic Systems, Artis Zeego X-Ray SystemsBfArM
mdprc 048 03 13 000Siemens Healthcare Diagnostics ProductMeasurements of Prothrombin Time , Sysmex® CS-2000i/2100i SystemsBfArM
mdprc 047 03 13 000Gebruder MartinBone screws , HBS2BfArM
mdprc 046 03 13 000ERBE Elektromedizin GmbHCoagulate, thermofuse , BiCision InstrumentsBfArM
mdprc 032 03 13 000Terumo Europe N.VHypodermic syringe, Terumo 50ML Luer lock syringeBfArM
mdprc 030 03 13 000Siemens Healthcare DiagnosticsSerum Calibrators , Syva® Emit® toxBfArM
mdprc 029 03 13 000Oxoid LtdOxoid Antimicrobial Susceptibility Testing Disc , CiprofloxacinBfArM
mdprc 028 03 13 000Animas CorporationInjection/ Infusion/ Transfusion/Dialysis , Animas 2020 Insulin PumpBfArM
mdprc 027 03 13 000GE HealthcareX-ray system , OEC UroView 2800BfArM
mdprc 026 03 13 000EndoSenseInjection, Infusion, Transfusion, DialysisBfArM
mdprc 018 03 13 000Cook MedicalPorts, Vascular Access, Vital-Port® Mini Titanium Detached Silicone Catheter Infusion PortMHRA
mdprc 017 03 13 000DiaSorin IncIVD Test Reagent/Kits, Immunoassay, Thyroid Hormone, Thyroxin, Free, fT4-CTK kitBfArM
mdprc 016 03 13 000Terumo Europe N.VTubing, Suction, Terumo Tubing Sets-sucker lineBfArM
mdprc 014 03 13 000Oxoid Ltd Div Thermo Fisher Scientific IncIVD ,Mueller Hinton Agar with Horse BloodBfArM
mdprc 013 03 13 000Data Innovations North AmericaIVD , Instrument Manager ( SW )BfArM
mdprc 012 03 13 000STEREOTAXISmagnetic catheter advancement , V-CAS and V-CAS DeflectBfArM
mdprc 011 03 13 000MediRoxDiluent , IVD , GHI 154BfArM
mdprc 010 03 13 000OrthofixOrthopedic Internal Fixation Systems, Spinal, Axial and Parallel Rod Connectors Used with Firebird Spinal Fixation SystemsBfArM
mdprc 009 03 13 000Stryker OrthopaedicsProsthesis Implantation Instruments, Orthopedic , Bioabsorbable ACL ScrewsBfArM
mdprc 008 03 13 000InnovaconIVD , Kit,. test cassette , Surestep Instalert brandsBfArM
mdprc 007 03 13 000Peter Brehmsterilization , WSI MX/PX-Titan® ExpertiseBfArM
mdprc 004 03 13 000Ondal medical system GmbHJoint prosthesis, hip , Acrobat Swing (“AC Swing”)BfArM
mdprc 003 03 13 000Carl Zeiss Meditec IncIntraocular lens , CT ASPHINA 409MPBfArM
mdprc 002 03 13 000HORIBA ABX Diagnosticsbuffered isotonic solution , ABX DILUENTBfArM
mdprc 001 03 13 000Alere San DiegoIVD , CardioProfiler and Profiler SOBBfArM
mdprc 197 02 13 000BioHorizons Implant Systems IncProsthesis Implantation Instruments, Dental, The product AutoTac Delivery Handle und AutoTac Titanium Starter KitBfArM
mdprc 196 02 13 000AscomHospital Communication Systems, Paging/Telephonic, Wireless, Mobile Monitoring Gateway (MMG)BfArM
mdprc 195 02 13 000BrainLABSurgical navigation system, system and accessories, Brainlab Ultrasound Adapter BK MedicalBfArM
mdprc 072 12 11 001SIEMENSReagent Cartridges, Dimension Clinical Chemistry System, multiple Creatinine (CREA) Flex reagent cartridge (DF33A)BfArM
mdprc 185 02 13 000GS Elektromedizinische Geraete Defibrillators, External, Manual, corpuls3 Defibrillator Monitoring SystemsBfArm
mdprc 184 02 13 000OxusOxygen Concentrators, Portable O2 ConcentratorsBfArm
mdprc 183 02 13 000SIEMENSMicroScan® Microbiology Systems,IVDBfArM
mdprc 182 02 13 000Ulrich GmbH & Co. KGPatient hoses, XD 2040BfArM
mdprc 181 02 13 000Hectec GmbHplanning system for orthopedic surgeons and clinics , MediCADBfArM
mdprc 180 02 13 000Hitachi Medical CorpComputed tomography , ECLOS ( 8 / 16 Slices )BfArM
mdprc 179 02 13 000Boule Medical ABlytic reagent , Medonic CA CA620/530 Lyse 10 LBfArM
mdprc 177 02 13 000SIEMENSInformation Systems ( PACS ) , SyngoBfArM
mdprc 176 02 13 000OlympusVideo, Video-DuodenoscopesBfArM
mdprc 175 02 13 000MAQUET IncTables, Operating, Hand and Arm Posturing DevicesBfArM
mdprc 149 02 13 000Thermo Fisher ScientificIVD Test Reagent/Kits, Microbiology, Bacteria, Culture Media, Plate, Brilliance VRE Ready-Poured Agar PlatesBfArM
mdprc 148 02 13 000Thermo Fisher DiagnosticsIVD Test Reagent/Kits, Microbiology, Bacteria, Culture Media, Oxoid Baird Parker Agar MediaBfArM
mdprc 146 02 13 000Siemens Healthcare Diagnostics ProductReagent cartridge and urine stabilizer , Dimension Vista System FlexBfArM
mdprc 144 02 13 000Terumo Cardiovascular Systems CorporationHeart-Lung Bypass Units, The Terumo® Advanced Perfusion System 1BfArM
mdprc 143 02 13 000American Medical Systems, IncProcedure Kit/Trays, Implant Delivery, Bladder Support,The AdVanceBfArM
mdprc 142 02 13 000Uptake MedicalInsufflators, Endoscopic, The InterVapor SystemBfArM
mdprc 141 02 13 000SynCardia Systems IncCompanion External BatteryBfArM
mdprc 140 02 13 000Biomet IncProstheses, Joint, Knee, The RHK Short Hinge AssemblyBfArM
mdprc 139 02 13 000Sekisui Virotech GmbHTest Kit has been designed for the detection and the quantitative determination of specific IgG antibodies against Influenza A in serum and plasma., Influenza A IgG ELISABfArM
mdprc 138 02 13 000Siemens Healthcare Diagnostics GmbHBatroxobin Reagent and Test Thrombin Reagent , Dade Ci-Trol 1BfArM
mdprc 137 02 13 000Iline MicrosystemsOral Anticoagulation Therapy (OAT) Point-of-care monitoring , Micro INRBfArM
mdprc 135 02 13 000GE HealthcareRadiographic system , C armBfArM
mdprc 132 02 13 000Siemens Medical SolutionsScanning Systems, Computed Tomography, Various Somatom Definition Computed Tomography SystemsBfArM
mdprc 130 02 13 001Philips HealthcareTherapy System , Sonalleve MR-HIFUBfArM
mdprc 129 02 13 000MedtronicKit , 75MM Pin, Single Packaged, Optical Procedure Pack Hip KitBfArM
mdprc 124 02 13 000Schulke & Mayr GmbHWound irrigation solution , octenilin wound gel , octenisept wound gelBfArM
mdprc 122 02 13 000Stryker OrthopaedicsProsthesis Implantation Instruments, Orthopedic , Ceramic Insertion ToolBfArM
mdprc 116 02 13 000stryker spineProsthesis Implantation Instruments, OrthopedicBfArM
mdprc 104 02 13 000SIEMENSRadiographic/Fluoroscopic Systems, Artis zeego / Artis zeeBfArM
mdprc 102 02 13 000OculentisLenses, Intraocular, LENTIS HydroSmart Yellow Intraocular LensesBfArM
mdprc 100 02 13 000SIEMENSRadiographic/Fluoroscopic Systems, Artis Zeego X-Ray SystemsBfArM
mdprc 096 02 13 000Cordis CorporationFemoral artery compression plug, ExosealTM Vascular Closure Device (VCDBfArM
mdprc 094 02 13 000Bard Access SystemsDisposable fixation device , permasorbBfArM
mdprc 092 02 13 001Philips Medical SystemsDigitalDiagnost X-ray systems , ELEVABfArM
mdprc 085 02 13 000CuretisAnalyzers, Laboratory, Microbiology, Susceptibility, Automated, The Unyvero System with Pneumonia Application the Unyvero System with Pneumonia ApplicationBfArM
mdprc 084 02 13 000Acumed LLCProsthesis Implantation Instruments, The depth gauge 80-0623BfArM
mdprc 083 02 13 000GE HealthcarePhysiologic Monitoring, Patient Data Module (PDM) Version 2.0BfArM
mdprc 082 02 13 000Penumbra IncCollection Canisters, The Penumbra System Canisters (PAPS1)BfArM
mdprc 081 02 13 000UNISIS CorpProcedure Kit/Trays, Anesthesia, Epidural, The UNIEVER Epidural/Combined Spinal Epidural Anesthesia MinitrayBfArM
mdprc 080 02 13 000Zimmer incProstheses, Joint, Hip, Femoral Component, The Versys® and Slotted Provisional Femoral HeadsBfArM
mdprc 079 02 13 000Temmler PharmaDressings/ Drapery, AcetocaustinBfArM
mdprc 076 02 13 000Linde Gas Therapeutics GmbHAnalgesia Units, Inhalation , LIVOPAN systemsBfArM
mdprc 075 02 13 000Permobil ABLifeStand LSCO , WheelchairBfArM
mdprc 074 02 13 000Thermo Fisher DiagnosticsIVD Test Reagent/Kits, Microbiology, Bacteria, Culture Media, Oxoid Columbia Agar with Sheep Blood PLUS ReagentsBfArM
mdprc 073 02 13 000OlympusDisinfectors, Liquid Germicide, Flexible Endoscope, ETD2, ETD2 Plus, and miniETD EndoDis Washer/Disinfectors with PPA Upgrade KitsBfArM
mdprc 072 02 13 000GS Elektromedizinische Geraete G Stemple GmbHDefibrillator/Pacemakers,External,corpuls3 Defibrillator/Monitoring SystemsBfArM
mdprc 070 02 13 000SBM SASOrthoses, Spine, Cervical, DUOCAGE M5 Cervical Cages and InsertsBfArM
mdprc 069 02 13 000IMRISOR100 Neurosurgical OR table Magnetic Resonance Imaging Systems.BfArM
mdprc 068 02 13 000Geratherm Medical AGWarming Units, Patient, Conductive Layer, UniqueTemp Arm/Shoulder-BlanketsBfArM
mdprc 067 02 13 000Siemens Medical SolutionsRadiotherapy Systems, ARTISTE, ONCOR, and PRIMUS Linear AcceleratorsBfArM
mdprc 066 02 13 000Wright Medical Technology IncPatella implants,plates, screws, all products packaged at the Toulon, France facility BfArM
mdprc 065 02 13 000Synthes IncCerviFix Pedicle ClampBfArM
mdprc 064 02 13 000Roche Diagnostics CorpIVDs, Elecsys Tg in combination with CalSet Tg ElecsysBfArM
mdprc 063 02 13 000ThermoFisher ScientificIVD Test Reagent/Kits, Immunoassay, Bone Metabolism Marker, Osteocalcin, BRAHMS Osteocalcin KRYPTOR ReagentsBfArM
mdprc 060 02 13 000Synthes IncOrthopedic Internal Fixation Systems, Spinal, Facet Wedge Trial Implants with Small Cannulated RaspBfArM
mdprc 059 02 13 000EtacChairs, Swift Mobile shower chair,BfArM
mdprc 043 02 13 000MedComRadiotherapy Systems, Proton Beam, The VeriSuite 1.8BfArM
mdprc 042 02 13 000B Braun Medical IncNeedles, Injection, Subcutaneous Port, Angled Surecan NeedlesBfArM
mdprc 041 02 13 000EKOS CorpCatheters, Vascular, Infusion, Peripheral, The EkoSonic MACH4 Endovascular DeviceBfArM
mdprc 040 02 13 000TerumoSyringes, Plunger, Luer Lock, The Terumo Syringe - 30ml Luer Lock/ CentricBfArM
mdprc 039 02 13 000Waldemar LINK GmbH & CoProstheses, Joint, Hip, Total, The Lubinus SPII Anatomically Adapted Hip Prosthesis SystemBfArM
mdprc 038 02 13 000MTS MaschinenbauRadiographic Systems, Digital, The Chrystal LT 201 X-ray systemBfArM
mdprc 037 02 13 000ESCADLenses, Arthroscope, Cystoscope, and Laparoscope Rigid LensesBfArM
mdprc 035 02 13 000Yuyao Ruixin Medical Appliance Co LtdHandpieces, Dental, RXGBK Standard Fiber-Optic Dental HandpiecesBfArM
mdprc 034 02 13 000Waldemar LINK GmbH & CoProstheses, Joint, Knee, Tibial Component, Endo-Model SL Knee Prosthesis System Tilastan Proximal Tibial SpacersBfArM
mdprc 033 02 13 000Trumpf Medical Systems, Inc.Tables, Operating, TruSystem 5500 Operating Table SystemsBfArM
mdprc 032 02 13 000Synthes IncBone-screw internal spinal fixation system, Cannulated Screw, 3.5mm, self-drill., L38/12mmBfArM
mdprc 031 02 13 000Reger Medizintechnik GmbHElectrodes, Electrosurgical, Monopolar ElectrodesBfArM
mdprc 030 02 13 000Philips HealthcareRadiographic Systems, Digital, Mammographic, Mammographic, MammoDiagnost DR Mammography Systems with Advanced StereoBfArM
mdprc 029 02 13 000Johann Stiegelmeyer & Co GmbHBeds, Electric, Amara and Amara-Tero Electric BedsBfArM
mdprc 027 02 13 000HUM GmbHAEROcheck Pulse OximetersBfArM
mdprc 026 02 13 000Hologic IncSoftware, Radiographic/Fluoroscopic System, InSight2 and InSight FD Mini C-Arm SystemsBfArM
mdprc 024 02 13 000CardioKinetix IncCatheters, Cardiac, Angiography, Ventricular, PARACHUTE Implant SystemsBfArM
mdprc 023 02 13 000Biomet IncProstheses, Joint, Hip, Total, Hyperion Extension SleevesBfArM
mdprc 022 02 13 000Siemens Healthcare DiagnosticsIMMULITE IGF-I Control ModuleBfArM
mdprc 021 02 13 000Siemens Healthcare DiagnosticsIVDs, Enzygnost® F1 +2 (monoclonal) kitBfArM
mdprc 020 02 13 000Servona GmbHServoport 3000 m, suction deviceBfArM
mdprc 019 02 13 000Philips Medical SystemsX-ray system, Essenta DR CompactBfArM
mdprc 018 02 13 000 Exatech Deutschland GmbHFlexible DrillsBfArM
mdprc 017 02 13 000DiaSys Diagnostic Systems GmbHIVDs, Creatinine PAP FSBfArM
mdprc 016 02 13 000Burmeier GmbH & Co.Care bed and bed insertBfArM
mdprc 015 02 13 000bioMerieux IncIVD, TPHA 100 kitBfArM
mdprc 014 02 13 000bioMerieux IncIVDs, chromID Strepto B agarBfArM
mdprc 013 02 13 000ARKRAYIVDs, SPOTCHEM i-Pack CRP Wide and SPOTCHEM D CRPBfArM
mdprc 012 02 13 000Advanced Sterilization ProductsSterilizing Units, Plasma, Sterrad 100S CassBfArM
mdprc 004 02 13 000Mediphacos LtdaIoflex Foldable Intraocular LensesBfArm
mdprc 003 02 13 000AesculapNails, Bone, The Targon PF NailBfArM
mdprc 002 02 13 000Bio-Rad Laboratories IncReagents, Immunoassay, Neuroendocrine, Cortisol Metabolite, KetochromeBfArM
mdprc 001 02 13 000Synthes IncDrill Bits, The CSLP System Ø 3.0mm Drill Bits and the Fixation SleeveBfArM
mdprc 128 01 13 000Biomet IncProstheses, Joint, Hip, Femoral Component, The Taperloc Femoral StemBfArM
mdprc 127 01 13 000DePuy International LimitedProstheses, Joint, Hip, Femoral Component, DePuy's cemented polished CoCr alloy femoral hip stems combined with MoM articulationBfArM
mdprc 126 01 13 000MBH International A/SCatheters, Colon, Anal Catheters, The Qufora Irrigation SystemBfArM
mdprc 125 01 13 000OrgenicsReagents, Serology, Virus, Hepatitis A, IgM Antibody, ImmunoComb II HAV IgMBfArM
mdprc 124 01 13 000GE HealthcareWarming Units, Blood/Intravenous Solution, Vital Signs enFlow IV Fluid Warmer StrapsBfArM
mdprc 123 01 13 000medac GmbHReagents, Serology, Virus, Epstein-Barr, IgG Antibody, EBV EBNA-1-IgG-ELISA PKS medacBfArM
mdprc 122 01 13 000Topcon Medical Laser SystemsScanning Systems, Laser, Optical Tomography, The examination system 3D Optical Coherence Tomography with the Software OCT ViewerBfArM
mdprc 121 01 13 000Carl Zeiss Meditec IncAqueous/Vitreous Humor Replacement Media, The silicone oil RT SIL-OL 1000BfArM
mdprc 120 01 13 000Elekta IncWorkstations, Radiotherapy, Planning, XiO Proton Spot BeamsBfArM
mdprc 119 01 13 000Integra NeuroSciencesCatheters, Intracranial, Ventricular, the Portnoy Ventricular CatheterBfArM
mdprc 118 01 13 000PromedonMesh, Polymeric, Calistar A and Calistar PBfArM
mdprc 117 01 13 000Siemens Healthcare DiagnosticsReagents, Clinical Chemistry, Rapid Test, Urine, Single Analyte, Dimension Vista HCYS Flex Reagent CartridgeBfArM
mdprc 116 01 13 000Fisher & Paykel Healthcare IncHumidifiers, Artificial Airway, HeatedBfArM
mdprc 113 01 13 000AGFA Corp.Information Systems, Data Management, Cardiology, IMPAX Cardiovascular DICOMstore ApplicationBfArM
mdprc 112 01 13 000Terumo Cardiovascular Systems CorporationBase for Terumo® Advanced PerfusionBfArM
mdprc 111 01 13 000Terumo Cardiovascular Systems CorporationElectronic Patient Gas System, Terumo Advanced Perfusion System 1 BfArM
mdprc 110 01 13 000Terumo Cardiovascular Systems CorporationRoller Pump, Terumo Advanced Perfusion System 1BfArM
mdprc 104 01 13 000Terumo Cardiovascular Systems CorporationPerfusion, Advanced Perfusion System 1 Sarns Centrifugal SystemsBfArM
mdprc 103 01 13 000Nucletron bvRadiotherapy Simulation Systems, Oncentra Masterplan and Ocentra External Beam BfArM
mdprc 102 01 13 000Carl Zeiss Meditec IncPhacoemulsification Units, Cataract Extraction, VISALIS S500 and V500 Phaco and Vitrectomy SystemsBfArM
mdprc 042 06 12 001ESCADGastroscopes, the EVG 21-28 Videogastroskop ENDOMED-DUO and EVC 21-37 Videocoloskop ENDOMED-DUOBfArM
mdprc 082 01 13 000Siemens Medical SolutionsInformation Systems, Data Management, Cardiology, syngo Dynamics Servers.BfArM
mdprc 081 01 13 000KISCOProsthesis Implantation Instruments, Orthopedic, Dynamometric T HandlesBfArM
mdprc 080 01 13 000Beaver Visitec International LtdProcedure Trays, Surgical, BVI CustomEyes Ophthalmic Procedure KitsBfArM
mdprc 079 01 13 000EMS Medical Group LtdTracheal Tube Holders, Clampholder for neonates and paediatric endotrachealtubesBfArM
mdprc 021 08 12 000Siemens Healthcare DiagnosticsIVDs, ADVIA Centaur / ADVIA Centaur XPBfArM
mdprc 020 08 12 000Kimberly Clark Health CareGowns, MicroCool breathable surgery gownsBfArM
mdprc 019 08 12 000StrykerCannulae, Radiofrequency CannulaeBfArM
mdprc 018 08 12 000DiaSys Diagnostic Systems GmbHReagent, one HbA1c IS, for one HbA1c FS, TruCal HbA1c liquid, TruLab HbA1c Level 1 and TruLab HbA1c Level 2BfArM
mdprc 017 08 12 000Nikkiso Europe GmbHDialysis, The OctoNova Hemofiltration DeviceBfArM
mdprc 016 08 12 000bioMerieux IncIVDs, VIDAS EBV VCA-EA IgGBfArM
mdprc 015 08 12 000ARKRAYReagent, CALIBRATOR 80BfArM
mdprc 014 08 12 000Carl Zeiss Meditec IncLenses, CT ASPHINA 409 MP intraocular lensesBfArM
mdprc 094 07 12 000Teleflex MedicalNeedle, The Duisburg NeedleBfArM
mdprc 092 07 12 000Otto Bock Healthcare Products GmbHProsthesis, 4R82 tube clamp adapterBfArM
mdprc 091 07 12 000Ortho-Clinical DiagnosticsReagents, VITROS Chemistry Products DGXN SlidesBfArM
mdprc 090 07 12 000Animas CorporationInsulin Pumps, AnimasBfArM
mdprc 086 07 12 000Human GmbhIVDs, ELISA test Imtec CIC IgGBfArM
mdprc 085 07 12 000Immucor GmbHIVDs, HPA BeadChip KitBfArM
mdprc 084 07 12 000Varian Medical SystemsRectal Retractor, The applicator part AL07289000BfArM
mdprc 083 07 12 000GA Generic Assays GmbHReagents, Anti-Gangliosid DotBfArM
mdprc 082 07 12 000OMNIlife scienceProstheses, Joint, Apex Knee System Tibial Base PlateBfArM
mdprc 081 07 12 000Siemens Healthcare DiagnosticsReagents, Dimension Vista Vancomycin Flex reagent cartridgeBfArM
mdprc 060 07 12 000Diagnostica StagoAutomated Haemostasis Instruments, STA SatelliteBfArM
mdprc 104 06 12 001Siemens Healthcare Diagnostics GmbHReagents, Dimension Vista System CA19-9 Flex reagent cartridgesBfArM
mdprc 052 07 12 000Siemens Medical SolutionsThe digital linear accelerators of type ARTISTE™ and ONCOR™BfArM
mdprc 051 07 12 000stryker spineDrills, spine, The Aviator drillBfArM
mdprc 050 07 12 000Philips HealthcareComputed tomography system, Intellispace Portal with software version 4.0 and 4.0.1 und Extended Brilliance Workspace with software version 4.5.0, 4.5.2, 4.5.3 and 4.5.4BfArM
mdprc 049 07 12 000Philips HealthcareComputed tomography system, The Intellispace Portal (ISP) Multi-Modality Tumor Tracking application with software version 4.0.1BfArM
mdprc 048 07 12 000TransMedicsOrgan care system, The OCS - Heart deviceBfArM
mdprc 047 07 12 000Sturdy IndustrialSterilizing Units, Autoclave HMT 232XBfArM
mdprc 046 07 12 000Ardo medical AGLamp, The Ardo Amemnc radiant lampBfArM
mdprc 045 07 12 000Siemens Medical SolutionsRadiation, Therapy, syngo RT Therapist 4.2BfArM
mdprc 026 07 12 000OlympusEndoscope, The HD Autoclavable Camera HeadBfArM
mdprc 025 07 12 000ExactechJoint prosthesis, The Equinoxe Shoulder SystemBfArM
mdprc 024 07 12 000LimacorporateJoint prosthesis, The eccentrical Adaptor Taper of the SMR Shoulder SystemBfArM
mdprc 023 07 12 000Axis Shield PoCIVDs, Afinion AS100 Analyzer and Afinion CRPBfArM
mdprc 022 07 12 000Biocompatibles LtdEmbolisation device, Bead BlockBfArM
mdprc 021 07 12 000Roche Diagnostics CorpData Management, Laboratory, AMPLILINK software v. 3.2BfArM
mdprc 016 07 12 000Tornier IncJoint prosthesis, CoCr femoral headsBfArM
mdprc 009 07 12 000Zimmer incProsthesis Implantation Instruments, The PathFinder NXT Pivoting Percutaneous Rod Holder InstrumentBfArM
mdprc 007 07 12 000MAQUET IncOperating Tabletops, the Magnus 1180.16Ax, 1180.16Fx and T285.7000 carbon-fibre table topsBfArM
mdprc 006 07 12 000Waldemar LINK GmbH & CoProstheses, The connection component rotational version of the Endo-Model SL Rotational and Hinge Knee Prosthesis SystemBfArM
mdprc 003 07 12 000Weinmannventilators, VENTIlogic LS und VENTIlogic plus ventilatorsBfArM
mdprc 002 07 12 000Zimmer incJoint Prosthesis, Allofit IT Alloclassic Shell (60/MM)BfArM
mdprc 001 07 12 000Impulse DynamicsPulse generators, Optimizer IIIBfArM
mdprc 147 06 12 000Siemens Medical SolutionsInformation Systems, syngo.plaza with an archive licenseBfArM
mdprc 146 06 12 000Ethicon Endo Surgery IncClips, LIGACLIP EXTRA LIGATING CLIP CARTRIDGESBfArM
mdprc 145 06 12 000Ormco CorpBrackets, Damon 3MX Bicuspid BracketsBfArM
mdprc 144 06 12 000Gas Control EquipmentAdaptors, NIST adaptors for Oxygen and AIRBfArM
mdprc 143 06 12 000EKU ElektronikNitric Oxide Delivery Units, NO-therapy Device in combination with a Patient Data Management SystemBfArM
mdprc 126 06 12 000OkonomedIVDs, Hemdiag StuhltestBfArM
mdprc 125 06 12 000P J Dahlhausen & CoA trocar catheter for pleural drainageBfArM
mdprc 124 06 12 000BD Diagnostic SystemsSyringes, The BD Preset 3ml. Arterial Gas SyringeBfArM
mdprc 103 06 12 000Carl Zeiss Meditec IncSilicone Oil, the silicone oil RT SIL-OL 5000-10ML Syringe.BfArM
mdprc 102 06 12 000Otto Bock Healthcare Products GmbHWheelchairs, Power wheelchairs XenoBfArM
mdprc 101 06 12 000I-FlowInfusion Pumps, the elastomeric infusion pump ON-Q with OnDemand bolus buttonBfArM
mdprc 100 06 12 000Nidek MedicalOxygen Concentrators, Nuvo, Nuvo 8 and Nuvo Lite branded oxygen concentratorsBfArM
mdprc 099 06 12 000HUM Homecare und MedizintechnikPositive Airway Pressure Units, AEROtube CSS1-1800-U1, CPAP-Universal-Tubing-SystemBfArM
mdprc 098 06 12 000Fresenius Medical CareApheresis Immunoadsorption Columns, The DALI LDL apheresis therapyBfArM
mdprc 097 06 12 000Schutz Dental GroupDental Implants, implant Impla Mini balltop 2,5/9,5 mmBfArM
mdprc 096 06 12 000OrthodynamicsProstheses, cemented 11 mm MML Adapter StemsBfArM
mdprc 095 06 12 000DiaSys Diagnostic Systems GmbHReagents, oneHbA1c FS / oneHbA1c ISBfArM
mdprc 089 06 12 000Andreas Hettich GmbH & Co KGCentrifuges, ROTOFIX 32ABfArM
mdprc 086 06 12 000Advanced Sterilization ProductsBiological Indicator , STERRAD Cycle Sure 24 BfArM
mdprc 085 06 12 000Trumpf Medical Systems, Inc.Operating lights, The Acrobat 3000 spring armBfArM
mdprc 084 06 12 000Cook IncCatheter Introducers-Hemostasis Valve, Check-Flo Performer Introducer SetsBfArM
mdprc 083 06 12 000OlympusFlexible Endoscope , Olympus ETD / Olymus miniETDBfArM
mdprc 082 06 12 000Beckman CoulterCalibrators, APO A1 and B CalibratorBfArM
mdprc 081 06 12 000Waters CorpSpectrometers, Xevo TQ MSBfArM
mdprc 080 06 12 000DiagenodeReagents, HSV1/2-050BfArM
mdprc 079 06 12 000Siemens Healthcare Diagnostics ProductReagents, Sysmex CS-2000i/CS-2100i SystemBfArM
mdprc 078 06 12 000Philips HealthcareRadiographic Units, MammoDiagnost DRBfArM
mdprc 077 06 12 000GründlerBreathing Circuits, ventilator Novalung vision alphaBfArM
mdprc 076 06 12 000Activaero GmbHNebulizers , Power supplies for Akita Jet and Akita II Apixneb inhalation devicesBfArM
mdprc 075 06 12 000B Braun Medical IncSyringes, Original-Perfusor® syringe 50 ml with cannulaBfArM
mdprc 074 06 12 000Lohmann & Rauscher InternationalSponges, green Toptex abdominal compressesBfArM
mdprc 044 06 12 000AGFA Corp.X-Ray Film, DRYSTAR DT2 MAMMO and DRYSTAR DT5.000I MAMMOBfArM
mdprc 043 06 12 000CardioFocusCatheters, Endoscopic Ablation System (EAS) – HeartLight CathetersBfArM
mdprc 041 06 12 000OptiMed Medizinische Instrumente GmbHNeedles, Gangi Special-Vertebroplasty Needle Set for Cemento-REBfArM
mdprc 040 06 12 000Karl BeeseGauze products with x-ray threadBfArM
mdprc 039 06 12 000BD BiosciencesIVD, BD Retic-Count ReagentBfArM
mdprc 063 03 12 000Waldemar LINK GmbH & CoTrial prostheses, Trail neck XXL with 40 mm femur axis distanceBfArM
mdprc 062 03 12 000Arjo HuntleighBathes, The airspa BlowerBfArM
mdprc 061 03 12 000DiaSys Diagnostic Systems GmbHReagents, Clinical Chemistry, Cystatin C FSBfArM
mdprc 047 03 12 000Medtronic Navigation IncGuides, Drill, adjustable drill stops used with Atlantis / Premier / Vertex systemsBfArM
mdprc 046 03 12 000MedtronicDefibrillator, Implantable Cardioverter Defibrillators EnTrust and EnTrust EscudoBfArM
mdprc 045 03 12 000Siemens Healthcare DiagnosticsIVDs, Clinical Chemistry, ADVIA Centaur and ADVIA Centaur XP Vitamin D (VitD) Assay (Test Definitions 1.0.CX and 1.0.CY)BfArM
mdprc 044 03 12 000Light Instruments LtdSyneron Dental Lasers LiteTouchBfArM
mdprc 043 03 12 000DiaSorin IncVDs, viral microbiology instrumentation, ETI-VCA-GBfArM
mdprc 042 03 12 000Smith & Nephew OrthopaedicOrthopaedic, surgery, Trigen Meta Semi-Extended Drill GuidesBfArM
mdprc 041 03 12 000Siemens Healthcare DiagnosticsIVDs, Vista Magnesium Flex reagent cartridgeBfArM
mdprc 040 03 12 000Siemens Medical SolutionsRadiology, Imaging, Siemens syngo.plazaBfArM
mdprc 016 03 12 000SIEMENSAxiom Sensis XPBfArM
mdprc 015 03 12 000PlanmecaIntra Mobile BaseBfArM
mdprc 014 03 12 000Geratherm Medical Diagnostic SystemsWarming blanket of the Geratherm OP-Warming SystemBfArM
mdprc 013 03 12 000Smith & Nephew OrthopaedicImplant surgical screw, Biosure-HA Interference ScrewBfArM
mdprc 012 03 12 000Aesculap IncJoint prothesis, Columbus Revision knee endoprosthesisBfArM
mdprc 175 02 12 000Hitachi Medical CorpScanning Systems, Computed Tomography, Coronary Analysis , Scenaria deviceBfArM
mdprc 174 02 12 000Woodway GmbHThe treadmills of the PPS SeriesBfArM
mdprc 173 02 12 000Given Imaging IncCatheter, AR ManoShieldBfArM
mdprc 172 02 12 000MicroMed Cardiovascular Inc.Implantable left ventricular assist device systems HeartAssist 5 LVASBfArM
mdprc 171 02 12 000Berlin Heart AGThe implantable left ventricular assist devices, IncorBfArM
mdprc 170 02 12 000MicroMed Cardiovascular Inc.Implantable ventricular assist devices, HeartAssist 5 LVASBfArM
mdprc 169 02 12 000Smith & Nephew OrthopaedicGliding Nail Blade HandleBfArM
mdprc 103 02 12 000MATHYSBone graft substitute, cyclOS PuttyBfArM
mdprc 102 02 12 000Waters CorpLaboratory, Masstrak Immunosuppressants XE RUO KitBfArM
mdprc 101 02 12 000Siemens Healthcare DiagnosticsIVDs, IMMULITE CK-MBBfArM
mdprc 100 02 12 000bioMerieux IncIVDs, ATB ANA EU KitBfArM
mdprc 099 02 12 000AesculapSterile Procedure Sets, SUSI InstrumentsBfArM
mdprc 098 02 12 000GE HealthcareLOGIQ S8 Ultrasound SystemBfArM
mdprc 097 02 12 000DiaSys Diagnostic Systems GmbHReagents, Clinical Chemistry, Creatinine PAP FSBfArM
mdprc 059 02 12 000Elekta IncMOSAIQ: Microsoft Regional Settings and RTP Import of MLC PlansBfArM
mdprc 058 02 12 000Boston Scientific LtdWingspan Stent with Gateway PTA Balloon CatheterBfArM
mdprc 029 02 12 000Ormco CorpOrthodontic brackets Spirit MBBfArM
mdprc 028 02 12 000GE HealthcareRadiation, Discovery NM/CT 670 SPECT/CT and Discovery NM 630 SPECT SystemsBfArM
mdprc 027 02 12 000Given Imaging IncRecorders, Bravo pH Monitoring SystemsBfArM
mdprc 006 02 12 000Wright Medical Technology IncJoint prosthesis, Taperloc Femoral StemBfArM
mdprc 005 02 12 000Restorative Therapies IncRT300 Functional Electrical StimulationBfArM
mdprc 004 02 12 000Philips HealthcareRadiation, Ingenuity CTBfArM
mdprc 003 02 12 000Instrumentation LaboratoryAPTT-based IL Locked Test Groups Coagulation AnalyzersBfArM
mdprc 002 02 12 000gabmedGab Control Strep A Test CardsBfArM
mdprc 001 02 12 000Astra Tech SverigeUrinary bladder catheters ,LoFric Nelaton 20 cm CH10BfArM
mdprc 095 01 12 000Haemonetics CorpBag, HAEMONETICS RED CELL DISPOSABLESBfArM
mdprc 073 01 12 000Stryker Osteosynthesis Intramedullary SolutionsT2 Arthrodesis NailBfArM
mdprc 072 01 12 000Roche Diagnostics CorpIVD, Elecsys 2010 analyzerBfArM
mdprc 071 01 12 000OlympusKnives, Surgical, EndoscopicBfArM
mdprc 070 01 12 000Memmert GmbH und Co KGHot air sterilisers SNE / SFE / SFP 200-800BfArM
mdprc 069 01 12 000Litos GmbHtitanium-coated wires for the External Fixator (llizarov-Ring Fixator)BfArM
mdprc 068 01 12 000SIEMENSRadiographic/Fluoroscopic Systems, Angiography/Interventional, AXIOM Artis and Artis Zee X-Ray SystemsBfArM
mdprc 067 01 12 000SIEMENSRadiation, x-ray, AXIOM Aristos FX Plus SystemsBfArM
mdprc 066 01 12 000Celon AG medical instrumentsElectrosurgical System Generators ESG-100BfArM
mdprc 020 01 12 000SEKISUI MEDICAL COSekisui Medical, Mediace TPLA Calibrator Set and Control SetBfArM
mdprc 019 01 12 000Nihon Kohden CorpMulti-modal intra-operative monitoring, neural function measuring system MEE-1000A Neuromaster.BfArM
mdprc 016 01 12 000Mini Crosser A/SScooter, Mini Crosser M1BfArM
mdprc 015 01 12 000B Braun Medical IncSutures, 70 cm Monosyn 3/0 Violet-ColoredBfArM
mdprc 095 12 11 000Trumpf Medical Systems, Inc.Surgical lighting systems iLED and TruLight, Sterilisable Handle ALCBfArM
mdprc 094 12 11 000Fisher & Paykel Healthcare IncHumidifier, PT100 myAIRVO & PT101 AIRVOBfArM
mdprc 093 12 11 000Varian Medical SystemsAccelerator system, stereotactic radiosurgery, Optical Guidance Platform (OGP)BfArM
mdprc 092 12 11 000Olympus Winter & IBE GmbHElectrosurgical unit ESG-400BfArM
mdprc 074 12 11 000Integra NeuroSciencesIntegra Non-sterile stainless steel stepdown connectorBfArM
mdprc 073 12 11 000Tosoh CorporationIVDs, Calibrator, AlA-PACK BHCGBfArM
mdprc 071 12 11 000Phadia LtdSoybean test, ImmunoCAP Allergen f14BfArM
mdprc 070 12 11 000Smiths MedicalWarmed fluids, IV administration, Level-1 Normothermic IV sets and Hotline blood and IV fluid warming setsBfArM
mdprc 069 12 11 000SorinExtracorporeal membrane oxygenation, oxygenatorsBfArM
mdprc 052 12 11 000Siemens Healthcare DiagnosticsThe CA 19-9 Test, ADVIA Centaur CP to ADVIA Centaur andBfArM
mdprc 051 12 11 000GEOMED Medizin-Technik GmbHASSISTO arm-systemsBfArM
mdprc 050 12 11 000Abbott VascularThe RX Accunet Embolic Protection SystemBfArM
mdprc 033 12 11 000OptiMed Medizinische Instrumente GmbHMedical instruments, Cemento PlusBfArM
mdprc 032 12 11 000Ortho-Clinical DiagnosticsIVD, VITROS Chemistry Calibrator Kit 16BfArM
mdprc 031 12 11 000Varian Medical SystemsX-ray, Radiology, HD120 MLC multileaf collimator, including C-Series and True-Beam configurations.BfArM
mdprc 030 12 11 000Newdeal SASMedical instruments, IPP ON Interphalangeal implantat holderBfArM
mdprc 029 12 11 000Smith & Nephew incImplant, Accuris ™ Tibial Insert Trial MED/LG part of ACCURIS Uni Knee System.BfArM
mdprc 028 12 11 000Boston Scientific LtdImplantable cardiovascular defibrillator, Monitors, LATITUDE® remote monitoring systemBfArM
mdprc 027 12 11 000Philips HealthcareRadiology, Brilliance 64, Ingenuity CT and Brilliance Big Bore CT systemsBfArM
mdprc 026 12 11 000Milenia BiotecIVD, Milenia QuickLine HIT MQHIT 1BfArM
mdprc 025 12 11 000MTP Medical Technical Promotion GMBH.Trocars, Single-Use Trocars.BfArM
mdprc 024 12 11 000Teleflex MedicalRespiratory, Flexislip/ Flexi -Slip™ Endotracheal Tube Stylet with Soft Distal.BfArM
mdprc 023 12 11 000DePuyKnee implant, LCS@ DuoFix FemurBfArM
mdprc 037 10 11 000Nikkiso Europe GmbHInjection, Infusion, Transfusion, Dialysis, EF-02D Filter for dialysate purificationBfArM
mdprc 036 10 11 000WeinmannVentilators, MEDUMAT Transport Ventilators with Integrated CO2 MeasurementBfArM
mdprc 035 10 11 000Varian Medical SystemsRadiotherapy, Proton Therapy SystemBfArM
mdprc 034 10 11 000Oxoid Div ThermoFisher Scientific MicrobiologyIVD, Oxoid Ready Prepared Medium Bolton BrothBfArM
mdprc 033 10 11 000Invacare CorporationOrthopedy, Rehabilitation, Scooter LeoBfArM
mdprc 032 10 11 000InnovaconIVD, Strep A Rapid Test Twist deviceBfArM
mdprc 031 10 11 000FujifilmDigital Radiography Systems, FDR AcSelerateBfArM
mdprc 030 10 11 000EndoSenseInjection, Infusion, Transfusion, Dialysis, TactiCath CathetersBfArM
mdprc 029 10 11 000Elekta/IMPACRadiotherapy, Radiation protection, MOSAIQ Oncology lnformation SystemBfArM
mdprc 028 10 11 000Carl ZeissOptics, Precision mechanics, MicroscopesBfArM
mdprc 027 10 11 000AnspachSurgical, Drill Systems, Cutting Burs and Irrigation ClipsBfArM