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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 054 03 18 001 | Keystone Dental Inc | Stage-1 Tissue Punch, Disposable, 4.5mm | BfArM, FDA https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162775 | | mdprc 061 04 18 000 | Becton Dickinson & Co. (BD) | BD Vacutainer Citrate Plus Blood Collection Tubes | BfArM | | mdprc 060 04 18 000 | BD Diagnostic Systems | VIASURE Flu A, Flu B and RSV Real Time PCR Detection Kit to be used by BD MAX | BfArM | | mdprc 059 04 18 000 | FEG Textiltechnik Forschungs-und Entwicklungsgesellschaft mbH | DynaMesh PR2 soft 2B , DynaMesh PR4 soft 2B | BfArM | | mdprc 058 04 18 000 | First Global Enterprises Limited | Oxygen Mask for adult, high concentration, non‐rebreather/AsidBonz | 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
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 |
|---|
| 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
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 099 04 18 000 | Medtronic | Covidien EEA Hemorrhoid and Prolapse Stapler Sets with DST Series Technology | NCMDR | | mdprc 097 04 18 000 | ArjoHuntleigh | Entroy Pool Lifters | NCMDR | | mdprc 096 04 18 000 | St. Jude Medical Inc | Battery Performance Alert and Cybersecurity Firmware Updates for Certain ICD & CRT-D Devices | NCMDR | | mdprc 095 04 18 000 | Alrazi Pharma Industries | Liquid Acid Concentrate for Haemodialysis-HDA08 | NCMDR | | mdprc 094 04 18 000 | Aesculap | Surgical PENIS CLAMP | NCMDR |
Swissmedic
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 082 04 18 000 | Becton Dickinson & Co. (BD) | BD Vacutainer EDTA tubes, BD Vacutainer Lithium Heparin tubes | Swissmedic | | mdprc 081 04 18 000 | MRC-Holland | SALSA MLPA Probemix P060 SMA | Swissmedic | | mdprc 080 04 18 000 | Siemens Healthcare Diagnostics Product | Atellica COAG 360 | Swissmedic | | mdprc 079 04 18 000 | Bio-Rad Laboratories Inc | Mueller Hinton | Swissmedic | | mdprc 078 04 18 000 | Becton, Dickinson And Company | Alaris SMARTSITE ADD-ON BAG ACCESS DEVICE | Swissmedic |
TGA
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 101 04 18 000 | Stryker Medtech | Sonopet Ultrasonic Products | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00323-1 | | mdprc 100 04 18 000 | Gyrus ACMI | Classic Series Reusable Active Cord designed to be used with Gyrus ACMI FOCUS 640, Bovie and other general purpose monopolar electrosurgical generators | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00326-1 | | mdprc 092 04 18 000 | Edwards Lifesciences | IntraClude Intra-aortic Occlusion Device | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00313-1 | | mdprc 091 04 18 000 | Phadia AB | EliA Intrinsic Factor Well | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00317-1 | | mdprc 090 04 18 000 | Philips Healthcare | Philips Ingenuity Core (728321) | http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00312-1 |
U.S FDA
Please click on an item below to view.
| Reference Number | Manufacturer | Device Type | Report Source |
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| mdprc 108 04 18 000 | Ace Surgical Supply Co., Inc | Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163464 | | mdprc 107 04 18 000 | Cook Medical | Cook Vacuum Pump | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=163165 | | mdprc 106 04 18 000 | Integra LifeSciences | TITAN | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162744 | | mdprc 105 04 18 000 | Life Technologies Limited. | Oncomine Dx Target Test. | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162895 | | mdprc 104 04 18 000 | Terumo Cardiovascular Systems Corporation | Terumo Advanced Perfusion System 1 Flow Module. | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162847 |
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