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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
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
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
Health Canada
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Reference NumberManufacturerDevice TypeReport Source
mdprc 065 05 15 000Roche Diagnostics LtdCANNABINOIDS II - ONLINE DAT and THC 2 http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2015/52821r-eng.php
mdprc 107 03 15 000Midmark Corp.Progeny Vantage Panoramic X-Ray SystemHealthy Canadians
mdprc 116 02 15 000Terumo..Titan 360 StabilizerHealth_Canada
HPRA ( Formerly IMB )
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Reference NumberManufacturerDevice TypeReport Source
mdprc 077 03 16 001S. R. Smith, LLCSplash Pool LiftMHRA
mdprc 076 03 16 000BrainLABCranial Image-Guided Surgery (IGS) SystemHPRA
mdprc 075 03 16 000Fannin NI LtdW11024 BURKHOLDERIA CEPACIA SPECIFIC AGARHPRA
mdprc 074 03 16 000Eli Lilly ReoPro Filter kitHPRA
mdprc 073 03 16 000Pennine HealthcareOSC-1210/48, Clear Graduated Oppo-Cath Suction Catheter, 10ch/48cm.HPRA
MDCO
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Reference NumberManufacturerDevice TypeReport Source
mdprc 052 03 12 000Varian Medical SystemsRadiology, Therapy. 4D Integrated Treatment Console and TrueBeamMDCO
mdprc 002 03 12 000Thoratec CorpImplantable, Thoratec HeartMate II® Left Ventricular Assist System.http://www.mdco.gov.hk/english/recalls/recalls_20120228a.html
mdprc 144 02 12 000BD Diagnostic SystemsBD PrepStain Vacuum Pumpshttp://www.mdco.gov.hk/english/recalls/recalls_20120213.html
mdprc 057 02 12 000Terumo Cardiovascular Systems CorporationMonitoring, Terumo CDI™ Blood Parameter Monitoring System 500http://www.mdco.gov.hk/english/recalls/recalls_20120126a.html
mdprc 056 02 12 000Abbott Molecular Inc Sub Abbott LaboratoriesIVD, Scanner. Abbott Molecular Bar Code Scanner User's Guidehttp://www.mdco.gov.hk/english/recalls/recalls_20120202b.html
MHRA
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 113 10 18 000Roche Diagnostics CorpAccuChek Aviva Plus Test StripMHRA
mdprc 068 01 14 001ColoplastDuowire guidewire (AEBD35).MHRA
mdprc 081 07 11 001MedtronicDrug Infusion Pumps, SynchroMed® II ImplantableNCMDR
mdprc 158 11 16 000Wright Medical Technology, Inc.Wright VariousMHRA
mdprc 157 11 16 000Merz pharmceuticalsCellfina System Prep Pack CP1MHRA
NCAR
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 052 03 15 001DePuysynthes Pedicle Awl 4.0mm w/Canevasit Handle : Pedicle Awl 4.0mm w/Silicone HandleNCMDR
mdprc 078 09 15 000Eurovema ABMiniflex, Flexmobil, FormaNCAR
mdprc 045 09 15 000Intuitive Surgical IncVinci Xi Surgical SystemNCAR
mdprc 015 09 15 000DIALAB GmbHASONCAR
mdprc 212 08 15 000Handicare ABTransition gate manual in combination with Reda ceiling lift unit or trolley HCS5 / HCS37NCAR
NCMDR
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Reference NumberManufacturerDevice TypeReport Source
mdprc 088 03 19 000Roche Diagnostics Corpcobas p 501 / 701 post-analytical units NCMDR
mdprc 079 03 19 000Ortho-Clinical DiagnosticsVITROS XT 7600 Integrated SystemNCMDR
mdprc 078 03 19 000B Braun Medical Inc.Connection Lead SP (12V) for Infusomat Space, Infusomat Space P and Perfusor SpaceNCMDR
mdprc 076 03 19 000Beckman Coulter Inc..MicroScan WalkAway InstrumentNCMDR
mdprc 066 03 19 000Ortho-Clinical DiagnosticsVITROS ® XT 7600 Integrated System NCMDR
SFDA
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Reference NumberManufacturerDevice TypeReport Source
mdprc 126 05 18 000Philips HealthcareHeartStart FRx, HeartStart Home, and Heartstart OnSite AEDsSFDA
Swissmedic
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 075 03 19 000Mikrogen GmbHrecomLine Helicobacter 2.0 IgG/IgASwissmedic
mdprc 074 03 19 000Leica Biosystems Nussloch GmbHLeica Biosystems Cryostats.Swissmedic
mdprc 073 03 19 000OlympusMAJ-209 Single-Use Suction ValveSwissmedic
mdprc 072 03 19 000Beckman Coulter UK LtdDxA 5000 Automation System.Swissmedic
mdprc 060 03 19 000MathysMod. rev. neck lateral with screw 60Swissmedic
TGA
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 087 03 19 000Biomet Spain Orthopaedics SLPolished Finned 1 Piece Tibial Tray 71mm http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00451-1
mdprc 077 03 19 000Topcon Corporation IMAGEnet 6 Ophthalmic Data System http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00440-1
mdprc 069 03 19 000Alba BioscienceALBAclone Anti-Leb Reagentshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00248-1
mdprc 068 03 19 000Edwards LifesciencesVAMP Optima Blood Sampling System http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00433-1
mdprc 067 03 19 000Medtronic A610 DBS Clinician Programmer Application http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00428-1
U.S FDA
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 085 03 19 000Smith & Nephew incJOURNEY II XR TIBIAL POSTERIOR KEEL PUNCHhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169782
mdprc 084 03 19 000LW Scientific, Inc.LW Scientific ZIP IQ PCV Centrifugehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171148
mdprc 083 03 19 000ConvaTecNelaton Urinary Catheter, Feeding Tube Metric, FilterFlow Suction Handle CH24, Forceps Bluehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170714
mdprc 082 03 19 000Becton Dickinson & Co. (BD)BD Synapsys Microbiology Informatics Solutionhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171162
mdprc 081 03 19 000Avitus Orthopaedics, Inc.Avitushttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171254