X
OK Your changes have been successfully saved
SFDA Home Page
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 104 07 17 000Angiomed GmbH & Co. Medizintechnik KG.Vivexx Carotid StentBfArM
mdprc 103 07 17 000DiaSys Diagnostic Systems GmbH.Creatinine PAP FSBfArM
mdprc 102 07 17 000Dr. Fooke-Achterrath Laboratorien GmbHTotal IgE-HRP EIABfArM
mdprc 101 07 17 000EtacFlex grab rail adhesive mountBfArM
mdprc 100 07 17 000Otto Bock Healthcare Products GmbHVoyager Evo rigid frame wheelchair BfArM
Health Canada
Please click on an item below to view.
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
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
Please click on an item below to view.
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 094 07 17 000BrainLABAiro Mobile CT scannerNCMDR
mdprc 071 07 17 000Roche Diagnostics Corpcobas c 501, 502 moduleNCMDR
mdprc 063 07 17 000Bio-Rad Medical DiagnosticsID-PapainNCMDR
mdprc 062 07 17 000Medtronic SAEuphora and Solarice Angioplasty catheter, balloon dilatationNCMDR
mdprc 057 07 17 000Philips HealthcarePhilips Brilliance iCTNCMDR
Swissmedic
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 114 07 17 000Joerns Healthcare LimitedOXFORD DIPPERSwissmedic
mdprc 113 07 17 000Resmed LimitedAstral 100, Astral 150Swissmedic
mdprc 112 07 17 000SeraCare Life SciencesACCURUN 51 Multi-Marker Hepatits Positive ControlSwissmedic
mdprc 111 07 17 000ThermoFisher Scientific Microbiology PerthThermoScientific Oxoid GC AgarSwissmedic
mdprc 110 07 17 000Ortho-Clinical DiagnosticsOrtho BioVue System Rh/K CassetteSwissmedic
TGA
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 081 07 17 000Beckman CoulterSynchron Systems Salicylate Reagenthttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00844-1
mdprc 080 07 17 000Alere LTDAlere HIV Combohttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00856-1
mdprc 079 07 17 000Baxter Corp CanadaHomeChoice and HomeChoice PRO Automated PD Cyclershttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00855-1
mdprc 078 07 17 000Cosman MedicalNitinol RF Reusable Electrodeshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00846-1
mdprc 077 07 17 000MAKO Surgical CorpMako Internal cPCI Card Cagehttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00857-1
U.S FDA
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 109 07 17 000GE Medical SystemsOEC 9800 and OEC 9900 Elitehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152098
mdprc 108 07 17 000Penumbra, Inc.3D Revascularization Deviceshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156554
mdprc 107 07 17 000PENTAX MedicalCart-Mounted Computer Systemshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155016
mdprc 106 07 17 000Medtronic SASpine Tools Install CDs Used with StealthStation S7 Systemshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155812
mdprc 105 07 17 000Medtronic SAVisualase Cooled Laser Applicator System 15 mm Tip Capshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156887