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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 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 064 02 19 000SIEMENSUROSKOP OMNIA and UROSKOP OMNIA MAXBfArM
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 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
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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 02 19 000Draeger Medical Systems Inc.Agila/Movita ceiling supply unitNCMDR
mdprc 052 02 19 000StrykerLIFEPAK 15 Defibrillators/MonitorsNCMDR
mdprc 049 02 19 000Roche Diagnostics Corpcobas p 612 pre-analaytical systemNCMDR
mdprc 048 02 19 000HUMAN Gesellschaft für Biochemica und Diagnostica GmbHIMTEC-dsDNA-AntibodyNCMDR
mdprc 047 02 19 000Cordis CorporationCordis Vista Brite Tip® & ADROITTM Guiding CathetersNCMDR
SFDA
Please click on an item below to view.
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 051 02 19 000Swemac Innovation ABMotec Wrist Radius CupSwissmedic
mdprc 088 12 17 002Boston Scientific Cardiac Rhythm Management GroupVALITUDE CRT-P, MOMENTUM CRT-D, AUTOGEN CRT-D , INOGEN CRT-D, VISIONIST CRT-P, VIGILANT CRT-D, CHARISMA CRT-D, DYNAGEN CRT-D, ORIGEN CRT-D, RESONATE CRT-DSwissmedic, BfArM, NCMDR
mdprc 087 12 17 001Boston Scientific Cardiac Rhythm Management GroupVALITUDE CRT-P, ALTRUA 2 Pacemaker, ESSENTIO Pacemaker, ACCOLADE Pacemaker, PROPONENT Pacemaker , VISIONIST CRT-PBfArM
mdprc 031 02 19 000CepheidXpert GBS.Swissmedic
mdprc 030 02 19 000Sterisets Medical ProductsBasin linersSwissmedic
TGA
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 069 01 19 002Medtronic Adapta Dual Chamber Pacemakers https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170377
mdprc 060 02 19 000Varian Medical SystemsARIA OIS for Radiation Oncology http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00169-1
mdprc 059 02 19 000Randox Laboratories Various Immunoassay Controls used with Siemens Immulite 2000 http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00179-1
mdprc 058 02 19 000Medrad Inc.Radimetrics CDM Software http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00204-1
mdprc 057 02 19 000GE HealthcarePanda iRes Warmer with ResusView Heart Rate Feature http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00196-1
U.S FDA
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 073 02 19 000Teleflex Medical ,Pilling COOLEY SUMPSUCTION TUBEhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170297
mdprc 072 02 19 000Smiths Medical International LimitedPortex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin and Portex Pulsator Arterial Blood Sampling Kit with Liquid Sodium Heparinhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166689
mdprc 071 02 19 000Signature OrthopaedicsGenius Total Knee Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170488
mdprc 070 02 19 000Ortho-Clinical DiagnosticsVITROS Immunodiagnostic Products Myoglobin Calibratorshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169785
mdprc 069 02 19 000bioMerieux IncVITEK 2 ASTN351 Test Kithttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170402