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 114 07 18 000Cook Inc,Chorion Villus Biopsy Needle SetBfArM
mdprc 113 07 18 000Dako Denmark A/SMonoclonal Mouse Anti-Human MSH2 FE11BfArM
mdprc 112 07 18 000Heraeus Medical GmbHCOPAL knee moulds size LBfArM
mdprc 111 07 18 000Leica Microsystems, Inc.DS9800 Bond Polymer Refine DetectionBfArM
mdprc 110 07 18 000Meditrade GmbHBeeSana Mullkompresse; 5x5 cm, 8-fachBfArM
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 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
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 103 07 18 000Ortho-Clinical DiagnosticsVITROS MicroWell AssaysNCMDR
mdprc 092 07 18 000bioMerieux IncVIDAS CA 15-3NCMDR
mdprc 091 07 18 000DiaMed GmbH.Anti-JkNCMDR
mdprc 077 07 18 000AbbottAlinity ci‐series System Control Module (SCM) NCMDR
mdprc 068 07 18 000Siemens Healthcare Diagnostics Dimension Vista LOCI Reaction VesselsNCMDR
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 101 07 18 000Intuitive Surgical Incda Vinci Xi A70_P8_B622 system softwareSwissmedic
mdprc 100 07 18 000CepheidXpert MTB/RIF UltraSwissmedic
mdprc 099 07 18 000Siemens Healthcare Diagnostics GmbHAtellica IM 1300 Analyzer, Atellica IM 1600 Analyzer, Atellica CH 930 Analyzer, Atellica Sample HandlerSwissmedic
mdprc 098 07 18 000EtacMolift 2-point Sling BarSwissmedic
mdprc 097 07 18 000Sedecal S.ANovaSwissmedic
TGA
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 102 07 18 000Integra LifeSciencesMAYFIELD Spine Table Adapters and Various Infinity XR2 Base Unitshttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00912-1
mdprc 025 07 18 001B Braun Surgical SASafil Sutures http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00737-1
mdprc 070 07 18 000LivaNova Platinium Implantable Cardiac Defibrillator (ICD) and Resynchronisation Therapy Defibrillator (CRT-D)http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00929-1
mdprc 067 07 18 000Getinge LancerGETINGE EDS8 (Endoscope Drying and Storage Cabinet) Compressorhttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00906-1
mdprc 054 07 18 000Elekta Inc.Leksell GammaPlan 11.1http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00844-1
U.S FDA
Please click on an item below to view.
Reference NumberManufacturerDevice TypeReport Source
mdprc 105 07 18 000Ethicon Inc.D-Special PROLENE Polypropylene and D-Special PRONOVA Hexafluoropropylene-VDF Sutureshttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165105
mdprc 104 07 18 000Fx SolutionsFx SOLUTIONS CENTERED HEADhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165089
mdprc 116 02 18 001PENTAX Europe GmbHPentax Video Duodenoscopehttp://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00887-1
mdprc 094 07 18 000Integra LifeSciencesThe UNICP bone fixation systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165161
mdprc 093 07 18 000Intel-GE Care Innovations LLCHealth Harmony Mobilehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165321