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Competent Authorities Composite Listing
BfArM
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 073 08 17 000 | ThermoFisher. | Phadia AB ImmunoCAP Herring Allergens | BfArM | | mdprc 072 08 17 000 | Becton Dickinson & Co. (BD) | BD MultiTEST CD3/CD8/CD45/CD4 | BfArM | | mdprc 071 08 17 000 | B Braun Surgical SA | Novosyn Quick Undyed Sterile Absorbable Surgical Sutures | BfArM | | mdprc 070 08 17 000 | TerumoBCT | FemoSeal Vascular Closure System | BfArM | | mdprc 069 08 17 000 | Leonhard Lang GmbH | Defibrillation Electrode SKINTACT DF59N and DF59NC | BfArM |
Health Canada
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HPRA ( Formerly IMB )
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| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 077 03 16 001 | S. R. Smith, LLC | Splash Pool Lift | MHRA | | mdprc 076 03 16 000 | BrainLAB | Cranial Image-Guided Surgery (IGS) System | HPRA | | mdprc 075 03 16 000 | Fannin NI Ltd | W11024 BURKHOLDERIA CEPACIA SPECIFIC AGAR | HPRA | | mdprc 074 03 16 000 | Eli Lilly | ReoPro Filter kit | HPRA | | mdprc 073 03 16 000 | Pennine Healthcare | OSC-1210/48, Clear Graduated Oppo-Cath Suction Catheter, 10ch/48cm. | HPRA |
MDCO
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| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 052 03 12 000 | Varian Medical Systems | Radiology, Therapy. 4D Integrated Treatment Console and TrueBeam | MDCO | | mdprc 002 03 12 000 | Thoratec Corp | Implantable, Thoratec HeartMate II® Left Ventricular Assist System. | http://www.mdco.gov.hk/english/recalls/recalls_20120228a.html | | mdprc 144 02 12 000 | BD Diagnostic Systems | BD PrepStain Vacuum Pumps | http://www.mdco.gov.hk/english/recalls/recalls_20120213.html | | mdprc 057 02 12 000 | Terumo Cardiovascular Systems Corporation | Monitoring, Terumo CDI™ Blood Parameter Monitoring System 500 | http://www.mdco.gov.hk/english/recalls/recalls_20120126a.html | | mdprc 056 02 12 000 | Abbott Molecular Inc Sub Abbott Laboratories | IVD, Scanner. Abbott Molecular Bar Code Scanner User's Guide | http://www.mdco.gov.hk/english/recalls/recalls_20120202b.html |
MHRA
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 081 07 11 001 | Medtronic | Drug Infusion Pumps, SynchroMed® II Implantable | NCMDR | | mdprc 158 11 16 000 | Wright Medical Technology, Inc. | Wright Various | MHRA | | mdprc 157 11 16 000 | Merz pharmceuticals | Cellfina System Prep Pack CP1 | MHRA | | mdprc 156 11 16 000 | Medtronic Inc | Affinity FusionTM Oxygenator with Integrated Arterial Filter and CVR | MHRA | | mdprc 155 11 16 000 | Handicare GmbH | Non-conforming coach bolt, Vertical Support | MHRA |
NCAR
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| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 052 03 15 001 | DePuysynthes | Pedicle Awl 4.0mm w/Canevasit Handle : Pedicle Awl 4.0mm w/Silicone Handle | NCMDR | | mdprc 078 09 15 000 | Eurovema AB | Miniflex, Flexmobil, Forma | NCAR | | mdprc 045 09 15 000 | Intuitive Surgical Inc | Vinci Xi Surgical System | NCAR | | mdprc 015 09 15 000 | DIALAB GmbH | ASO | NCAR | | mdprc 212 08 15 000 | Handicare AB | Transition gate manual in combination with Reda ceiling lift unit or trolley HCS5 / HCS37 | NCAR |
NCMDR
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| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 061 09 17 000 | Philips Healthcare | Brilliance 64/ Ingenuity CT / Ingenuity Core / Ingenuity Core128 | NCMDR | | mdprc 036 09 17 000 | Medtronic SA | MiniMed Infusion Sets | NCMDR | | mdprc 077 10 16 001 | St. Jude Medical Inc | Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura and Unify Quadra | NCMDR | | mdprc 005 09 17 000 | St. Jude Medical Inc. | Accent/ Anthem, Accent MRI/ Accent ST, Assurity/ Allure and Assurity MRI devices | NCMDR | | mdprc 004 09 17 000 | TRUMPF Medizin Systeme GmbH. | Universal Arm Support | NCMDR |
Swissmedic
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 043 09 17 000 | Aaren Scientific, Incorporated | EC-3 Posterior Chamber Hydrophobic Acrylic Lens | Swissmedic | | mdprc 094 08 17 001 | Abbott Molecular Inc. | Abbott RealTime HIV-1 Qualitative Amplification Reagent Kit | Swissmedic | | mdprc 042 09 17 000 | Afikim Electric Vehicles | Powered Scooter | Swissmedic | | mdprc 041 09 17 000 | Ethicon Endo Surgery Inc | Vicryl Rapide | Swissmedic | | mdprc 040 09 17 000 | InterVascular SA | Intergard Woven | Swissmedic |
TGA
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 060 09 17 000 | iMDsoft Ltd | MetaVision ICU | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01173-2 | | mdprc 059 09 17 000 | ThermoFisher Scientific Microbiology Perth | Oxoid AST Disc - Ceftazidime CAZ10 | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01190-1 | | mdprc 058 09 17 000 | St. Jude Medical Inc | NM Implantable Pulse Generator within the Infinity and Proclaim device families | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01184-1 | | mdprc 057 09 17 000 | Siemens Medical Solutions | Artis zee and Artis Q systems with software version VD11C | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01186-1 | | mdprc 056 09 17 000 | Radiometer America Inc | Radiometer AQT90FLEX Immunoassay analyser | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01195-1 |
U.S FDA
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 050 09 17 000 | FUJIFILM Corporation | Various Duodenoscopes ,. | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154542 | | mdprc 049 09 17 000 | Baxter Corp Canada | Baxter Amia Automated Peritoneal Dialysis Set with Cassette | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158638 | | mdprc 048 09 17 000 | Becton Dickinson & Co. (BD) | BD Needle 22GA 11/2in SafetyGlide | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157172 | | mdprc 047 09 17 000 | Boston Scientific | FFR LinkFFR Signal Processing Module | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156068 | | mdprc 046 09 17 000 | X-Laser Llc | Aurora, Caliente Aurora, PSX400, Mobile Beat Max, Mobile Beat Max MKII, Xbeam, and Hawk 500 models | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158026 |
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