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Competent Authorities Composite Listing
BfArM
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| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 071 03 19 000 | Teleflex Medical | Gibeck HME Filter + Catheter Mount, RUSCH Connectors Bulk for Breathing Circuit | BfArM | | mdprc 045 03 19 001 | Ethicon Inc. | VICRYL Suture and VICRYL Plus Suture Products | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00390-1 | | mdprc 052 03 19 000 | LivaNova PLC | 3T Heater-Cooler Systems. | BfArM | | mdprc 051 03 19 000 | Mathys | balanSys Femur Holder | BfArM | | mdprc 050 03 19 000 | PREVOR GmbH | PREVIN- MINI-TAD & MIKRO-TAD | 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 113 10 18 000 | Roche Diagnostics Corp | AccuChek Aviva Plus Test Strip | MHRA | | mdprc 068 01 14 001 | Coloplast | Duowire guidewire (AEBD35). | MHRA | | 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 |
NCAR
Please click on an item below to view.
| 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 088 03 19 000 | Roche Diagnostics Corp | cobas p 501 / 701 post-analytical units | NCMDR | | mdprc 079 03 19 000 | Ortho-Clinical Diagnostics | VITROS XT 7600 Integrated System | NCMDR | | mdprc 078 03 19 000 | B Braun Medical Inc. | Connection Lead SP (12V) for Infusomat Space, Infusomat Space P and Perfusor Space | NCMDR | | mdprc 076 03 19 000 | Beckman Coulter Inc.. | MicroScan WalkAway Instrument | NCMDR | | mdprc 066 03 19 000 | Ortho-Clinical Diagnostics | VITROS ® XT 7600 Integrated System | NCMDR |
SFDA
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| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 126 05 18 000 | Philips Healthcare | HeartStart FRx, HeartStart Home, and Heartstart OnSite AEDs | SFDA |
Swissmedic
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 075 03 19 000 | Mikrogen GmbH | recomLine Helicobacter 2.0 IgG/IgA | Swissmedic | | mdprc 074 03 19 000 | Leica Biosystems Nussloch GmbH | Leica Biosystems Cryostats. | Swissmedic | | mdprc 073 03 19 000 | Olympus | MAJ-209 Single-Use Suction Valve | Swissmedic | | mdprc 072 03 19 000 | Beckman Coulter UK Ltd | DxA 5000 Automation System. | Swissmedic | | mdprc 060 03 19 000 | Mathys | Mod. rev. neck lateral with screw 60 | Swissmedic |
TGA
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 087 03 19 000 | Biomet Spain Orthopaedics SL | Polished Finned 1 Piece Tibial Tray 71mm | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00451-1 | | mdprc 077 03 19 000 | Topcon Corporation | IMAGEnet 6 Ophthalmic Data System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00440-1 | | mdprc 069 03 19 000 | Alba Bioscience | ALBAclone Anti-Leb Reagents | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00248-1 | | mdprc 068 03 19 000 | Edwards Lifesciences | VAMP Optima Blood Sampling System | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00433-1 | | mdprc 067 03 19 000 | Medtronic | A610 DBS Clinician Programmer Application | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00428-1 |
U.S FDA
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 085 03 19 000 | Smith & Nephew inc | JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169782 | | mdprc 084 03 19 000 | LW Scientific, Inc. | LW Scientific ZIP IQ PCV Centrifuge | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171148 | | mdprc 083 03 19 000 | ConvaTec | Nelaton Urinary Catheter, Feeding Tube Metric, FilterFlow Suction Handle CH24, Forceps Blue | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170714 | | mdprc 082 03 19 000 | Becton Dickinson & Co. (BD) | BD Synapsys Microbiology Informatics Solution | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171162 | | mdprc 081 03 19 000 | Avitus Orthopaedics, Inc. | Avitus | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=171254 |
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