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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 067 01 18 000DiaSys Diagnostic Systems GmbH.reagent 2 in oneHbA1c FSBfArM
mdprc 066 01 18 000Medix BiochemicaActim RSVBfArM
mdprc 065 01 18 000Smith & Nephew incR3 0 Hole Acetabular Shell 50mm and R3 Constrained Acetabular Liner 52mmBfArM
mdprc 064 01 18 000The Binding SiteRheumatoid Factor Kit for use on SPAPLUSBfArM
mdprc 063 01 18 000Zimmer IncACE Trochanteric Nail System ProductsBfArM
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 )
Please click on an item below to view.
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
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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
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 077 01 18 000Ethicon Inc.ETHICON VICRYL RAPIDE™ SUTURE & ENDOLOOP® COATED VICRYL® SUTURE / ENDOLOOP® PDS® II SUTURENCMDR
mdprc 070 01 18 000Medtronic AFFINITY® NT Cardiotomy/Venous Reservoir (CVR) Stand-Alone NCMDR
mdprc 086 11 17 001Cordis CorporationCordis S.M.A.R.T.® Flex Vascular Stent System.NCMDR
mdprc 043 01 18 000Philips HealthcarePhilips IntelliVue Information Center (PIIC) iXNCMDR
mdprc 038 01 18 000GE HealthcareCARESCAPE Central Station (CSCS) NCMDR
Swissmedic
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 068 01 18 000Siemens Healthcare Diagnostics GmbHCyclosporine, DHEA-SO4, Folate and HBc IgM AssaysSwissmedic
mdprc 034 07 17 002Roche Diagnostics cobas e 601, cobas e 602 MODULAR Analyticshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160292
mdprc 050 01 18 000Contura International A/SBulkamid VURSwissmedic
mdprc 049 01 18 000MAQUET IncVOLISTASwissmedic
mdprc 048 01 18 000Implant Direct Sybron Manufacturing,LLCSwishTapered and SwishPlus ImplantSwissmedic
TGA
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 092 12 17 001Greiner Bio-One IncVacuette Minicollect Complete 1mL Sodium Citrate 3.2%.http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01505-1
mdprc 076 01 18 000HOLOGIC Panther and Panther Fusion Systems with 19-in monitorhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00065-1
mdprc 075 01 18 000Moog Inc. Moog Infusion System Administration Setshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00053-1
mdprc 069 01 18 000Beckman CoulterFC 500 Series Flow Cytometershttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00051-1
mdprc 061 01 18 000Allen Medical SystemsRadiolucent Spine Surgery Framehttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00024-1
U.S FDA
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 078 01 18 000Valeant Pharmaceuticals International, IncSPAG2 unit nebulizershttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155627
mdprc 074 01 18 000Measurement Specialties Inc.Measurement Specialties Reusable Temperature Probe Autoclavablehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158538
mdprc 073 01 18 000Philips HealthcareBrilliance iCT, Brilliance 64, Ingenuity Core, and Ingenuity Core128 Computed Tomography Systemshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160870
mdprc 072 01 18 000Smith & Nephew incMiniMod Small Bone Plating Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160614
mdprc 071 01 18 000The Anspach Effort, IncOSCILLATING SAW ATTACHMENThttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=160829