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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 104 07 17 000 | Angiomed GmbH & Co. Medizintechnik KG. | Vivexx Carotid Stent | BfArM | | mdprc 103 07 17 000 | DiaSys Diagnostic Systems GmbH. | Creatinine PAP FS | BfArM | | mdprc 102 07 17 000 | Dr. Fooke-Achterrath Laboratorien GmbH | Total IgE-HRP EIA | BfArM | | mdprc 101 07 17 000 | Etac | Flex grab rail adhesive mount | BfArM | | mdprc 100 07 17 000 | Otto Bock Healthcare Products GmbH | Voyager Evo rigid frame wheelchair | 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
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 094 07 17 000 | BrainLAB | Airo Mobile CT scanner | NCMDR | | mdprc 071 07 17 000 | Roche Diagnostics Corp | cobas c 501, 502 module | NCMDR | | mdprc 063 07 17 000 | Bio-Rad Medical Diagnostics | ID-Papain | NCMDR | | mdprc 062 07 17 000 | Medtronic SA | Euphora and Solarice Angioplasty catheter, balloon dilatation | NCMDR | | mdprc 057 07 17 000 | Philips Healthcare | Philips Brilliance iCT | NCMDR |
Swissmedic
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 114 07 17 000 | Joerns Healthcare Limited | OXFORD DIPPER | Swissmedic | | mdprc 113 07 17 000 | Resmed Limited | Astral 100, Astral 150 | Swissmedic | | mdprc 112 07 17 000 | SeraCare Life Sciences | ACCURUN 51 Multi-Marker Hepatits Positive Control | Swissmedic | | mdprc 111 07 17 000 | ThermoFisher Scientific Microbiology Perth | ThermoScientific Oxoid GC Agar | Swissmedic | | mdprc 110 07 17 000 | Ortho-Clinical Diagnostics | Ortho BioVue System Rh/K Cassette | Swissmedic |
TGA
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 081 07 17 000 | Beckman Coulter | Synchron Systems Salicylate Reagent | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00844-1 | | mdprc 080 07 17 000 | Alere LTD | Alere HIV Combo | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00856-1 | | mdprc 079 07 17 000 | Baxter Corp Canada | HomeChoice and HomeChoice PRO Automated PD Cyclers | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00855-1 | | mdprc 078 07 17 000 | Cosman Medical | Nitinol RF Reusable Electrodes | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00846-1 | | mdprc 077 07 17 000 | MAKO Surgical Corp | Mako Internal cPCI Card Cage | http://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 Number | Manufacturer | Device Type | Report Source |
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| mdprc 109 07 17 000 | GE Medical Systems | OEC 9800 and OEC 9900 Elite | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=152098 | | mdprc 108 07 17 000 | Penumbra, Inc. | 3D Revascularization Devices | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156554 | | mdprc 107 07 17 000 | PENTAX Medical | Cart-Mounted Computer Systems | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155016 | | mdprc 106 07 17 000 | Medtronic SA | Spine Tools Install CDs Used with StealthStation S7 Systems | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=155812 | | mdprc 105 07 17 000 | Medtronic SA | Visualase Cooled Laser Applicator System 15 mm Tip Caps | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156887 |
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