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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 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
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
Please click on an item below to view.
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 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
mdprc 155 11 16 000Handicare GmbHNon-conforming coach bolt, Vertical SupportMHRA
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 061 09 17 000Philips HealthcareBrilliance 64/ Ingenuity CT / Ingenuity Core / Ingenuity Core128NCMDR
mdprc 036 09 17 000Medtronic SAMiniMed Infusion SetsNCMDR
mdprc 077 10 16 001St. Jude Medical IncFortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura and Unify QuadraNCMDR
mdprc 005 09 17 000St. Jude Medical Inc.Accent/ Anthem, Accent MRI/ Accent ST, Assurity/ Allure and Assurity MRI devicesNCMDR
mdprc 004 09 17 000TRUMPF Medizin Systeme GmbH.Universal Arm SupportNCMDR
Swissmedic
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Reference NumberManufacturerDevice TypeReport Source
mdprc 043 09 17 000Aaren Scientific, IncorporatedEC-3 Posterior Chamber Hydrophobic Acrylic LensSwissmedic
mdprc 094 08 17 001Abbott Molecular Inc.Abbott RealTime HIV-1 Qualitative Amplification Reagent KitSwissmedic
mdprc 042 09 17 000Afikim Electric VehiclesPowered ScooterSwissmedic
mdprc 041 09 17 000Ethicon Endo Surgery IncVicryl RapideSwissmedic
mdprc 040 09 17 000InterVascular SAIntergard WovenSwissmedic
TGA
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 060 09 17 000iMDsoft LtdMetaVision ICU http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01173-2
mdprc 059 09 17 000ThermoFisher Scientific Microbiology PerthOxoid AST Disc - Ceftazidime CAZ10 http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01190-1
mdprc 058 09 17 000St. Jude Medical IncNM Implantable Pulse Generator within the Infinity and Proclaim device families http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01184-1
mdprc 057 09 17 000Siemens Medical SolutionsArtis zee and Artis Q systems with software version VD11C http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01186-1
mdprc 056 09 17 000Radiometer America IncRadiometer AQT90FLEX Immunoassay analyser http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01195-1
U.S FDA
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 050 09 17 000FUJIFILM CorporationVarious Duodenoscopes ,.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154542
mdprc 049 09 17 000Baxter Corp CanadaBaxter Amia Automated Peritoneal Dialysis Set with Cassettehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158638
mdprc 048 09 17 000Becton Dickinson & Co. (BD)BD Needle 22GA 11/2in SafetyGlidehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157172
mdprc 047 09 17 000Boston ScientificFFR LinkFFR Signal Processing Modulehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156068
mdprc 046 09 17 000X-Laser LlcAurora, Caliente Aurora, PSX400, Mobile Beat Max, Mobile Beat Max MKII, Xbeam, and Hawk 500 modelshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158026