BfArM - Federal Institute for Drugs and Medical Devices

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15,017 results

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Recall of the Cortex Screw, DePuy Synthes PDF, 3MB, File does not meet accessibility standards Date: 09. September 2014 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 05516/14

Corrective action for the products medi Clutch Lock and medi Modular Clutch Lock, medi GmbH & Co. KG PDF, 186KB, File does not meet accessibility standards Date: 09. September 2014 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology - prostheses (exoprostheses)
Reference 04629/14

Corrective Action Persona Knee System, Zimmer PDF, 297KB, File does not meet accessibility standards Date: 08. September 2014 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 05547/14

Customer Safety Advisory Notice for Symbia S and T Series camera systems, Siemens AG Healthcare PDF, 736KB, File does not meet accessibility standards Date: 05. September 2014 Topics: Medical devices Type: Customer information

Product group Radiological technology - equipment for nuclear medical functional and localisation diagnostics
Reference 05556/14

Vigilance System Date: 03. September 2014 Topics: Medical devices Type: Article

In according with the Act on Medical Devices (MPG) and the German Safety Plan for Medical Devices (MPSV), the Federal Institute for Drugs and Medical Devices (BfArM) ensures the central collection, analysis and evaluation of risks arising from the …

Corrective action for the product Liaison® Tg, DiaSorin PDF, 313KB, File does not meet accessibility standards Date: 02. September 2014 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 03966/14

Urgent Safety Notice for VITROS® Immunodiagnostic Products CA19-9 Calibrators and Reagent Packs Lot 1320, Ortho Clinical Diagnostics PDF, 273KB, File does not meet accessibility standards Date: 02. September 2014 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 04274/14

Urgent Safety Notice for the BD EpiCenter™ v6.12A, v6.20A, v6.40A (used in conjunction with MALDI BioTyper), Becton Dickinson PDF, 46KB, File does not meet accessibility standards Date: 02. September 2014 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 04899/14

Corrective action for HemosIL AcuStar HIT-Ab(PF4-H), Instrumentation Laboratory PDF, 36KB, File does not meet accessibility standards Date: 02. September 2014 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 05093/14

Urgent Safety Notice for the product AbbVie nasojejunal (NJ) tubes, AbbVie, Inc. PDF, 26KB, File does not meet accessibility standards Date: 02. September 2014 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - probes
Reference 02823/14