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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 067 02 19 000 | Aesculap | ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM | BfArM | | mdprc 066 02 19 000 | Bucher Leichtbau AG | EMS Stretcher | BfArM | | mdprc 065 02 19 000 | Dr. Heni Software GmbH & Co. KG | Zenzy 2.46 software | BfArM | | mdprc 047 12 18 002 | Implant Direct Sybron Manufacturing,LLC | InterActive Precision IO Scan Adapter | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01610-1 | | mdprc 064 02 19 000 | SIEMENS | UROSKOP OMNIA and UROSKOP OMNIA MAX | BfArM |
Health Canada
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HPRA ( Formerly IMB )
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| Reference Number | Manufacturer | Device Type | Report Source |
|---|
| 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
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 061 02 19 000 | Draeger Medical Systems Inc. | Agila/Movita ceiling supply unit | NCMDR | | mdprc 052 02 19 000 | Stryker | LIFEPAK 15 Defibrillators/Monitors | NCMDR | | mdprc 049 02 19 000 | Roche Diagnostics Corp | cobas p 612 pre-analaytical system | NCMDR | | mdprc 048 02 19 000 | HUMAN Gesellschaft für Biochemica und Diagnostica GmbH | IMTEC-dsDNA-Antibody | NCMDR | | mdprc 047 02 19 000 | Cordis Corporation | Cordis Vista Brite Tip® & ADROITTM Guiding Catheters | NCMDR |
SFDA
Please click on an item below to view.
| 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 051 02 19 000 | Swemac Innovation AB | Motec Wrist Radius Cup | Swissmedic | | mdprc 088 12 17 002 | Boston Scientific Cardiac Rhythm Management Group | VALITUDE CRT-P, MOMENTUM CRT-D, AUTOGEN CRT-D , INOGEN CRT-D, VISIONIST CRT-P, VIGILANT CRT-D, CHARISMA CRT-D, DYNAGEN CRT-D, ORIGEN CRT-D, RESONATE CRT-D | Swissmedic, BfArM, NCMDR | | mdprc 087 12 17 001 | Boston Scientific Cardiac Rhythm Management Group | VALITUDE CRT-P, ALTRUA 2 Pacemaker, ESSENTIO Pacemaker, ACCOLADE Pacemaker, PROPONENT Pacemaker , VISIONIST CRT-P | BfArM | | mdprc 031 02 19 000 | Cepheid | Xpert GBS. | Swissmedic | | mdprc 030 02 19 000 | Sterisets Medical Products | Basin liners | Swissmedic |
TGA
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
|---|
| mdprc 069 01 19 002 | Medtronic | Adapta Dual Chamber Pacemakers | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170377 | | mdprc 060 02 19 000 | Varian Medical Systems | ARIA OIS for Radiation Oncology | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00169-1 | | mdprc 059 02 19 000 | Randox Laboratories | Various Immunoassay Controls used with Siemens Immulite 2000 | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00179-1 | | mdprc 058 02 19 000 | Medrad Inc. | Radimetrics CDM Software | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00204-1 | | mdprc 057 02 19 000 | GE Healthcare | Panda iRes Warmer with ResusView Heart Rate Feature | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00196-1 |
U.S FDA
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 073 02 19 000 | Teleflex Medical , | Pilling COOLEY SUMPSUCTION TUBE | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170297 | | mdprc 072 02 19 000 | Smiths Medical International Limited | Portex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin and Portex Pulsator Arterial Blood Sampling Kit with Liquid Sodium Heparin | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=166689 | | mdprc 071 02 19 000 | Signature Orthopaedics | Genius Total Knee System | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170488 | | mdprc 070 02 19 000 | Ortho-Clinical Diagnostics | VITROS Immunodiagnostic Products Myoglobin Calibrators | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169785 | | mdprc 069 02 19 000 | bioMerieux Inc | VITEK 2 ASTN351 Test Kit | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170402 |
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