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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 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
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
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Reference NumberManufacturerDevice TypeReport Source
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
mdprc 156 11 16 000Medtronic IncAffinity FusionTM Oxygenator with Integrated Arterial Filter and CVRMHRA
NCAR
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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 052 11 17 000Medtronic SASynchroMed II Implantable Drug Infusion Pump.NCMDR
mdprc 051 11 17 0003M Health Care LtdBair Hugger Temperature Monitoring SensorsNCMDR
mdprc 050 11 17 000Philips HealthcareBrilliance ICT, Brilliance iCT SP, lQon Spectral CTNCMDR
mdprc 005 09 17 002St. Jude Medical Inc.Accent/ Anthem, Accent MRI/ Accent ST, Assurity/ Allure and Assurity MRI deviceshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158781
mdprc 015 11 17 000Elekta Business Area Software Systems IMPAC Medical Systems Inc.Agility 3.2NCMDR
Swissmedic
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Reference NumberManufacturerDevice TypeReport Source
mdprc 040 11 17 000A&E Medical CorporationMYO/Punch, A&E Surgical PunchSwissmedic
mdprc 039 11 17 000Biom'upHEMOSNOW, COVA+, MATRIBONESwissmedic
mdprc 038 11 17 000LivaNova PLCCP5 CENTRIFUGAL PUMPSwissmedic
mdprc 008 11 17 000Arcomed AGVolumed Set ( Infusion set )Swissmedic
mdprc 007 11 17 000Implant Direct Sybron Manufacturing,LLCSimplyInterActive ImplantSwissmedic
TGA
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 055 11 17 000DePuy International LimitedAcetabular Cup Introducerhttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01385-1
mdprc 054 11 17 000LivaNova Deutschland GmbH.Sorin Group perfusion system – Heater Cooler 1T deviceshttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01370-1
mdprc 053 11 17 000LivaNova Deutschland GmbH.Sorin Group perfusion system – Heater Cooler 3T deviceshttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01368-1
mdprc 011 11 17 000Actelion Pharmaceuticals Veletri Consumables Kit with non Flow-Stop CADD Medication Cassette Reservoirshttp://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01369-1
mdprc 010 11 17 000AGFA Corp.Drystar DT 2 C Hardcopy Film 14" x 17"http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01371-1
U.S FDA
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Reference NumberManufacturerDevice TypeReport Source
mdprc 049 11 17 000Smiths Medical ASD Inc..CADD Medication Cassette Reservoirhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159024
mdprc 048 11 17 000WalkMed Infusion, LLCReservoir Bag for Infusion Pumphttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159086
mdprc 037 11 17 000Zimmer inc Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Kneehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159084
mdprc 036 11 17 000Windstone Medical Packaging, IncT&A Packhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159349
mdprc 035 11 17 000Terumo BCT IncHarvest Graft Delivery GDP-10 Procedure Packs ,https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=159146