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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 114 07 18 000 | Cook Inc, | Chorion Villus Biopsy Needle Set | BfArM | | mdprc 113 07 18 000 | Dako Denmark A/S | Monoclonal Mouse Anti-Human MSH2 FE11 | BfArM | | mdprc 112 07 18 000 | Heraeus Medical GmbH | COPAL knee moulds size L | BfArM | | mdprc 111 07 18 000 | Leica Microsystems, Inc. | DS9800 Bond Polymer Refine Detection | BfArM | | mdprc 110 07 18 000 | Meditrade GmbH | BeeSana Mullkompresse; 5x5 cm, 8-fach | 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 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 | | mdprc 156 11 16 000 | Medtronic Inc | Affinity FusionTM Oxygenator with Integrated Arterial Filter and CVR | MHRA |
NCAR
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| 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 103 07 18 000 | Ortho-Clinical Diagnostics | VITROS MicroWell Assays | NCMDR | | mdprc 092 07 18 000 | bioMerieux Inc | VIDAS CA 15-3 | NCMDR | | mdprc 091 07 18 000 | DiaMed GmbH. | Anti-Jk | NCMDR | | mdprc 077 07 18 000 | Abbott | Alinity ci‐series System Control Module (SCM) | NCMDR | | mdprc 068 07 18 000 | Siemens Healthcare Diagnostics | Dimension Vista LOCI Reaction Vessels | 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 101 07 18 000 | Intuitive Surgical Inc | da Vinci Xi A70_P8_B622 system software | Swissmedic | | mdprc 100 07 18 000 | Cepheid | Xpert MTB/RIF Ultra | Swissmedic | | mdprc 099 07 18 000 | Siemens Healthcare Diagnostics GmbH | Atellica IM 1300 Analyzer, Atellica IM 1600 Analyzer, Atellica CH 930 Analyzer, Atellica Sample Handler | Swissmedic | | mdprc 098 07 18 000 | Etac | Molift 2-point Sling Bar | Swissmedic | | mdprc 097 07 18 000 | Sedecal S.A | Nova | Swissmedic |
TGA
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 102 07 18 000 | Integra LifeSciences | MAYFIELD Spine Table Adapters and Various Infinity XR2 Base Units | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00912-1 | | mdprc 025 07 18 001 | B Braun Surgical SA | Safil Sutures | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00737-1 | | mdprc 070 07 18 000 | LivaNova | Platinium Implantable Cardiac Defibrillator (ICD) and Resynchronisation Therapy Defibrillator (CRT-D) | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00929-1 | | mdprc 067 07 18 000 | Getinge Lancer | GETINGE EDS8 (Endoscope Drying and Storage Cabinet) Compressor | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00906-1 | | mdprc 054 07 18 000 | Elekta Inc. | Leksell GammaPlan 11.1 | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00844-1 |
U.S FDA
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 105 07 18 000 | Ethicon Inc. | D-Special PROLENE Polypropylene and D-Special PRONOVA Hexafluoropropylene-VDF Sutures | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165105 | | mdprc 104 07 18 000 | Fx Solutions | Fx SOLUTIONS CENTERED HEAD | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165089 | | mdprc 116 02 18 001 | PENTAX Europe GmbH | Pentax Video Duodenoscope | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00887-1 | | mdprc 094 07 18 000 | Integra LifeSciences | The UNICP bone fixation system | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165161 | | mdprc 093 07 18 000 | Intel-GE Care Innovations LLC | Health Harmony Mobile | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=165321 |
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