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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 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
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 050 01 19 000CooperSurgical, Inc.SYMMETRY OLSEN® SINGLE-USE ELECTROCAUTERY FORCEPS / PENCILS / CORDSNCMDR
mdprc 049 01 19 000Carl Zeiss Inc.VISULENS 500 NCMDR
mdprc 036 01 19 000Varian Medical SystemsARIA Oncology Information System for Radiation OncologyNCMDR
mdprc 035 01 19 000Linet spol. s r.o.Eleganza 2NCMDR
mdprc 029 01 19 000Philips HealthcarePhilips PageWriter TC Cardiographs (TC20/30/50/70) NCMDR
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 054 01 19 000PerkinElmer Life and Analytical SciencesDELFIA / AutoDELFIA hCG KitSwissmedic
mdprc 053 01 19 000Thermo Fisher Scientific Inc.Oxoid M.I.C.E Meropenem MA0121Swissmedic
mdprc 052 01 19 000Medtronic SANIM Eclipse System, Single Use Direct Nerve ProbesSwissmedic
mdprc 024 01 19 000Unimed S.A.UNIMED NeedlesSwissmedic
mdprc 023 01 19 000Wing Plast ABProctoscopeSwissmedic
TGA
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 055 01 19 000Cook Inc.UNIVERSA Soft & Firm Ureteral Stent Sets, PTFE Wire Guide, Percutaneous Entry Set & Bander Ureteral Diversion Open-End Stent Set http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00068-1
mdprc 013 01 19 001ImmucorPanocell-16 Kit NCMDR
mdprc 014 01 19 000Limacorporate S.p.a.Revision femoral neck H60mm lateralised + Screw http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00001-1
mdprc 135 12 18 000Agilent Technologies, Inc.Autostainer Slide Rackshttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01606-1
mdprc 133 12 18 000Getinge Disinfection ABGETINGE XS32 Flat Screen Holder https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01602-1
U.S FDA
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 045 01 19 000Zimmer, INC….Biomet DVR Crosslock Screwshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169576
mdprc 044 01 19 000Smith & Nephew incSL PLUS MIA DOUBLE OFFSET ADAPTERhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170307
mdprc 043 01 19 000Canadian Hospital SpecialtiesMEDRX POLYURETHANE FEEDING TUBEhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169778
mdprc 042 01 19 000Arrow International IncArrow CVChttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169383
mdprc 041 01 19 000Cardinal-HealthPresource Kit Total Joint Packhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169742