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Corrective action for the IBC Aortic Punch products, International Biophysics Corporation PDF, 50KB, File does not meet accessibility standards Date: 03. August 2015 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - vascular surgery
Reference 04383/15

Safety Information for the MicroSil IF and MicroSil IFT intraocular lenses, HumanOptics AG PDF, 117KB, File does not meet accessibility standards Date: 03. August 2015 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 04421/15

Corrective action for the m2000sp E-series Instrument and m24sp Instrument, PDF, 33KB, File does not meet accessibility standards Date: 03. August 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 05065/14

Urgent Safety Notice for the Parechovirus r-gene® product, bioMérieux SA PDF, 89KB, File does not meet accessibility standards Date: 03. August 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 04218/15

Urgent Safety Notice for the TurnPike Spiral and TurnPike Gold catheters, Vascular Solutions, Inc. PDF, 79KB, File does not meet accessibility standards Date: 03. August 2015 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 04587/15

Safety Notice for the Fine Pressure Regulator, Synthes GmbH PDF, 4MB, File does not meet accessibility standards Date: 30. July 2015 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 04580/15

Corrective action for the Allura Xper system, Philips Healthcare PDF, 301KB, File does not meet accessibility standards Date: 30. July 2015 Topics: Medical devices Type: Customer information

Product group Radiological technology - radiological equipment for vascular diagnostics
Reference 04348/15

Safety Notice for the Trinder reagents (package inserts for the products will be updated), DIALAB GmbH PDF, 131KB, File does not meet accessibility standards Date: 30. July 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 04359/15

Recall for the Aspen/Alpine and Lineum Torque Handles, Biomet Spine LLC PDF, 621KB, File does not meet accessibility standards Date: 30. July 2015 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 02013/15

Recall for KYPHON® 11 Gauge Bone Access Needles, Medtronic on behalf of Argon Medical PDF, 95KB, File does not meet accessibility standards Date: 30. July 2015 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 04010/15

Corrective action for the Philips HeartStart XL+ Defibrillator/Monitor, Philips Healthcare PDF, 110KB, File does not meet accessibility standards Date: 30. July 2015 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 04521/15

Updated Information for Crea A and Crea B membrane units, RADIOMETER PDF, 22KB, File does not meet accessibility standards Date: 30. July 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 07458/14

Corrective action for the ADVIA Centaur XPT System, Siemens Healthcare Diagnostics PDF, 157KB, File does not meet accessibility standards Date: 29. July 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 00873/15

Safety Notice for the Össur prosthetic feet with attached aluminum male adapter, Össur hf PDF, 105KB, File does not meet accessibility standards Date: 29. July 2015 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology - prostheses (exoprostheses)
Reference 04387/15

Recall for the Modular Knee Joint, Otto Bock HealthCare GmbH PDF, 111KB, File does not meet accessibility standards Date: 29. July 2015 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology - prostheses (exoprostheses)
Reference 04374/15

Recall for the Gazin® Balls 2+3 and Gazin® Balls 2+2, Lohmann & Rauscher GmbH & Co. KG PDF, 57KB, File does not meet accessibility standards Date: 29. July 2015 Topics: Medical devices Type: Customer information

Product group Dressings / Pads - swabs, sponges, wipes, swabsticks
Reference 04371/15

Urgent Safety Notice for the product RadiForce RX440, RX650, RX850 and GX540, EIZO Corporation PDF, 3MB, File does not meet accessibility standards Date: 28. July 2015 Topics: Medical devices Type: Customer information

Product group Radiological technology - Radiological screen
Reference 04186/15

Safety Notice for the VITROS® 5,1 FS Chemistry System, Ortho-Clinical Diagnostics, Inc. PDF, 879KB, File does not meet accessibility standards Date: 28. July 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 04183/15

Corrective action for the Fixation kit N20, Radiometer Basel PDF, 18KB, File does not meet accessibility standards Date: 28. July 2015 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 04188/15

Corrective action for the AGC Dual Articular 2000 Knee Femoral Component, Biomet UK Ltd. PDF, 2MB, File does not meet accessibility standards Date: 28. July 2015 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 04161/15

Corrective action for Rival® PTA Dilatation Catheters, Bard Peripheral Vascular (BPV) PDF, 177KB, File does not meet accessibility standards Date: 28. July 2015 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 04507/15

Recall of EnVeo™ R Loading Systems, Medtronic CoreValve LLC PDF, 111KB, File does not meet accessibility standards Date: 28. July 2015 Topics: Medical devices Type: Customer information

Product group Non-active implants - cardiac surgery
Reference 04354/15

Recall/Updated Information for the Triathlon Distal Capture Assembly, Stryker® Orthopaedics PDF, 153KB, File does not meet accessibility standards Date: 28. July 2015 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 01244/15

Urgent Safety Notice for the ADVIA Chemistry Acetaminophen Reagent, Siemens Healthcare Diagnostics PDF, 40KB, File does not meet accessibility standards Date: 28. July 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 04187/15

Urgent Safety Notice for BD BBL™ Vancomycin Screen Agar, Becton, Dickinson & Company PDF, 113KB, File does not meet accessibility standards Date: 27. July 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 04201/15

Recall of the 200 mm sinus-SuperFlex-635 self-expanding nitinol stent system, optimed Medizinische Instrumente GmbH PDF, 75KB, File does not meet accessibility standards Date: 27. July 2015 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 04517/15

Labeling Updates Notification for Medtronic’s Deep Brain Stimulation (DBS), Medtronic Inc. PDF, 166KB, File does not meet accessibility standards Date: 27. July 2015 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - biostimulators
Reference 04523/15

Recall of Triathlon Inserts, Stryker® Orthopaedics PDF, 62KB, File does not meet accessibility standards Date: 27. July 2015 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 04368/15

Urgent Safety Notice for the 1.5T SENSE Body Coils used with ACS-NT, Intera 1.5T and Achieva 1.5T MR Systems, Philips Healthcare PDF, 378KB, File does not meet accessibility standards Date: 27. July 2015 Topics: Medical devices Type: Customer information

Product group Electromedical fields - equipment for MR tomography
Reference 04336/15

Urgent Safety Notice for GL Control N and P on the Innovastar®, DiaSys Diagnostic Systems GmbH PDF, 2MB, File does not meet accessibility standards Date: 27. July 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 04212/15