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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 051 01 19 000 | Roche Diagnostics Corp | cobas t 511 and t 711 - Coagulation analyzer | BfArM | | mdprc 048 01 19 000 | Elekta Inc | Elekta Unity | BfArM | | mdprc 047 01 19 000 | Gebrueder Martin GmbH & Co KG , | monopolar electrode handles smartPen for active electrodes with 2.4 mm attachment | BfArM | | mdprc 046 01 19 000 | EKF DIAGNOSTIC GmbH | Quo-Test A1C Test Kit | BfArM | | mdprc 084 07 18 002 | ConvaTec | Suction Catheters, Gastro-enteral Tubes | NCMDR |
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
Please click on an item below to view.
| 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 050 01 19 000 | CooperSurgical, Inc. | SYMMETRY OLSEN® SINGLE-USE ELECTROCAUTERY FORCEPS / PENCILS / CORDS | NCMDR | | mdprc 049 01 19 000 | Carl Zeiss Inc. | VISULENS 500 | NCMDR | | mdprc 036 01 19 000 | Varian Medical Systems | ARIA Oncology Information System for Radiation Oncology | NCMDR | | mdprc 035 01 19 000 | Linet spol. s r.o. | Eleganza 2 | NCMDR | | mdprc 029 01 19 000 | Philips Healthcare | Philips PageWriter TC Cardiographs (TC20/30/50/70) | 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 054 01 19 000 | PerkinElmer Life and Analytical Sciences | DELFIA / AutoDELFIA hCG Kit | Swissmedic | | mdprc 053 01 19 000 | Thermo Fisher Scientific Inc. | Oxoid M.I.C.E Meropenem MA0121 | Swissmedic | | mdprc 052 01 19 000 | Medtronic SA | NIM Eclipse System, Single Use Direct Nerve Probes | Swissmedic | | mdprc 024 01 19 000 | Unimed S.A. | UNIMED Needles | Swissmedic | | mdprc 023 01 19 000 | Wing Plast AB | Proctoscope | Swissmedic |
TGA
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 055 01 19 000 | Cook Inc. | UNIVERSA Soft & Firm Ureteral Stent Sets, PTFE Wire Guide, Percutaneous Entry Set & Bander Ureteral Diversion Open-End Stent Set | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00068-1 | | mdprc 013 01 19 001 | Immucor | Panocell-16 Kit | NCMDR | | mdprc 014 01 19 000 | Limacorporate S.p.a. | Revision femoral neck H60mm lateralised + Screw | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2019-RN-00001-1 | | mdprc 135 12 18 000 | Agilent Technologies, Inc. | Autostainer Slide Racks | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01606-1 | | mdprc 133 12 18 000 | Getinge Disinfection AB | GETINGE XS32 Flat Screen Holder | https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01602-1 |
U.S FDA
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 045 01 19 000 | Zimmer, INC…. | Biomet DVR Crosslock Screws | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169576 | | mdprc 044 01 19 000 | Smith & Nephew inc | SL PLUS MIA DOUBLE OFFSET ADAPTER | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=170307 | | mdprc 043 01 19 000 | Canadian Hospital Specialties | MEDRX POLYURETHANE FEEDING TUBE | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169778 | | mdprc 042 01 19 000 | Arrow International Inc | Arrow CVC | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169383 | | mdprc 041 01 19 000 | Cardinal-Health | Presource Kit Total Joint Pack | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169742 |
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