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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 062 10 18 001 | Richard Wolf GmbH | TEXAS Bronchoscope Tube | BfArM, NCMDR | | mdprc 057 11 18 001 | Civco Medical Instruments Inc | L25 Needle Guide Bracket | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168897 | | mdprc 050 12 18 000 | curasan AG | Curavisc, Hyaluronic Acid 1% | BfArM | | mdprc 049 12 18 000 | Elekta Inc | MOSAIQ release version 2.64 SP9 and higher | BfArM | | mdprc 048 12 18 000 | Henry Schein, Inc.. | Henry Schein CU-1000 Halogen Light | 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
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| 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 055 12 18 000 | Elekta Inc. | MOSAIQ Radiation Oncology | NCMDR | | mdprc 036 12 18 000 | Ethicon Inc. | PROXIMATE Hemorrhoidal Circular Stapler | NCMDR | | mdprc 035 12 18 000 | Siemens Healthcare Diagnostics GmbH | Atellica IM Anti-Thyroglobulin (aTG) Positive Bias | NCMDR | | mdprc 034 12 18 000 | Siemens Healthcare Diagnostics GmbH | ADVIA Centaur Anti-Thyroglobulin (aTG) Positive Bias, ADVIA Centaur, XP, XPT and CP | NCMDR | | mdprc 033 12 18 000 | Abbott | CP3000 w/ CTS and w/o CTS 230V | 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 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 021 12 18 000 | Bonesupport | CERAMENT G, CERAMENT BONE VOID FILLER and CERAMENT V | Swissmedic | | mdprc 020 12 18 000 | BIOHIT OYJ | Lactose intolerance quick test | Swissmedic | | mdprc 019 12 18 000 | Gambro Lundia AB | CWP 800 RO1 220-240V/ 380-415V 50Hz, CWP 800 HW 220-240V/ 380-415V 50Hz, Clinic Panel | Swissmedic | | mdprc 078 11 18 000 | Alere Scarborough, Inc. | Alere BinaxNOW Legionella with the Alere Reader | Swissmedic |
TGA
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
|---|
| mdprc 101 11 18 001 | Medtronic | Suction/Anticoagulation Assembly Lines | BfArM | | mdprc 002 12 18 002 | Medtronic | Medtronic HeartWare HVAD System Battery Charger | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169057 | | mdprc 028 12 18 000 | Cis Bio International | Cisbio - Chromogranin A (CGA-ELISA) | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01522-1 | | mdprc 027 12 18 000 | Shimadzu Medical Systems. | Digital Angiography System Trinias | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01487-1 | | mdprc 026 12 18 000 | Synovis Micro Companies Alliance Inc. | Synovis GEM4183C Coupler Forceps | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01519-1 |
U.S FDA
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 054 12 18 000 | Zimmer, INC…. | Comprehensive Mini Stem, Orthopedic Salvage System (OSS) | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168913 | | mdprc 053 12 18 000 | Tosoh Corporation | AIA360 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167366 | | mdprc 052 12 18 000 | Leoni Fiber Optics GmbH | Laser Fiber Assy-Single Use | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168872 | | mdprc 051 12 18 000 | Arjo Inc | Flite Clip Sling, 4 Point | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=168967 | | mdprc 030 12 18 000 | Pfizer Limited | Various Thermacare Heat Wraps | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167683 |
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