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Urgent Safety Information regarding burrs, Richard Wolf GmbH PDF, 10MB, File does not meet accessibility standards Date: 01. December 2015 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 06354/15

Safety Notice for the product GlucoMen® LX Sensor – updated Instructions for Use (IFU) -, A. Menarini Diagnostics PDF, 1MB, File does not meet accessibility standards Date: 01. December 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 08567/15

Safety Notice / Recall for HOYA iSert IOLs, HOYA Surgical Optics GmbH PDF, 533KB, File does not meet accessibility standards Date: 01. December 2015 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 07417/15

Corrective action for the BIRMINGHAM HIP™ Modular Head (monoblock BHMH), Smith & Nephew Orthopaedics Ltd. PDF, 99KB, File does not meet accessibility standards Date: 01. December 2015 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 08625/15

Urgent Safety Notice for the VITROS® 3600 and 5600 Systems Software Version 3.2 & Below, Ortho Clinical Diagnostics PDF, 321KB, File does not meet accessibility standards Date: 01. December 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 08307/15

Urgent Safety Notice for the Optitrol A Multimarker Control, DiaMex GmbH PDF, 41KB, File does not meet accessibility standards Date: 01. December 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 08577/15

Corrective action for the Dimension Vista® System Flex® reagent cartridge and urine stabilizer B2MIC, Siemens Healthcare Diagnostics PDF, 28KB, File does not meet accessibility standards Date: 01. December 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 08137/15

Urgent Safety Notice for BD Plastipack™ Syringes und BD™ Oral-Syringes included in the KitPacks®, Lohmann & Rauscher GmbH & Co. KG PDF, 18KB, File does not meet accessibility standards Date: 30. November 2015 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 06769/15

Urgent Safety Notice for the Procedure Pak containing BD Plastipak syringes, Mölnlycke Health Care AB PDF, 557KB, File does not meet accessibility standards Date: 30. November 2015 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - syringes and cannulas
Reference 07919/15

Corrective action for PiGalileo Hip Pressfit Impactor NAV Instruments, Smith & Nephew PDF, 80KB, File does not meet accessibility standards Date: 30. November 2015 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 08879/15

Corrective action for the Sofia® Legionella FIA, Quidel Corporation PDF, 676KB, File does not meet accessibility standards Date: 30. November 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 08267/15

Urgent Safety Notice for Masimo rainbow® Reusable Sensors (for rainbow SET® Devices with SpCO®, SpO2, and SpMet®), Masimo Corp. PDF, 147KB, File does not meet accessibility standards Date: 30. November 2015 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 08363/15

Follow-up Information concerning the Camino® ICP-Monitor and Licox® PtO2-Monitor, Integra LifeSciences PDF, 377KB, File does not meet accessibility standards Date: 30. November 2015 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 02563/15

Corrective action for the IntellaTip MiFi XP Asymmetric (N4) Curves, Boston Scientific Corp. PDF, 159KB, File does not meet accessibility standards Date: 30. November 2015 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 08843/15

Recall for the Tracoe larynx stoma button, TRACOE medical GmbH PDF, 310KB, File does not meet accessibility standards Date: 30. November 2015 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology - care of natural and artificial body orifices
Reference 08522/15

Recall of a single lot of the Maxican Titanium Screw 4.5x 55mm cannulated, Normed Medizin-Technik GmbH PDF, 116KB, File does not meet accessibility standards Date: 30. November 2015 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 08515/15

Urgent Safety Notice for the product CD22 (S-HCL-1) APC (CE-IVD), Becton, Dickinson and Company (BD) PDF, 174KB, File does not meet accessibility standards Date: 26. November 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 08306/15

Safety Notice for the product Oncentra® Simulation v2.X, Elekta PDF, 167KB, File does not meet accessibility standards Date: 26. November 2015 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy simulator
Reference 00437/11

Corrective action for the product Triathlon MIS Modular Distal Capture, Stryker Orthopaedics PDF, 76KB, File does not meet accessibility standards Date: 26. November 2015 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 07481/15

Recall of one lot of Synex Vertebral Body Replacements, DePuy Synthes PDF, 917KB, File does not meet accessibility standards Date: 26. November 2015 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 08432/15

Urgent Safety Notice for the InSync® III Cardiac Resynchronization Therapy Pacemakers (CRT-P), Medtronic PDF, 45KB, File does not meet accessibility standards Date: 26. November 2015 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - cardiac pacemakers
Reference 08410/15

Recall for the Vented Paclitaxel Set, Baxter PDF, 105KB, File does not meet accessibility standards Date: 26. November 2015 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion kits
Reference 08382/15

Recall for Exeter Small Tapered Pin Reamer and Exeter Large Tapered Pin Reamer, Stryker® Orthopaedics PDF, 42KB, File does not meet accessibility standards Date: 26. November 2015 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 08370/15

Corrective action for the XPer Flex Cardio Patient Monitoring System, Philips Healthcare PDF, 268KB, File does not meet accessibility standards Date: 26. November 2015 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 08649/15

Urgent Safety Notice for the Refill set DUO (Auffüllset DUO), ECOMEDIS PDF, 835KB, File does not meet accessibility standards Date: 25. November 2015 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - drug pumps
Reference 08381/15

Synthes GmbH: Recall for the Locking Screw Stardrive, self-tapping, 3.5 mm PDF, 1MB, File does not meet accessibility standards Date: 25. November 2015 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 08400/15

Safety Notice for the MYLA® software, bioMérieux PDF, 551KB, File does not meet accessibility standards Date: 25. November 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 08246/15

Corrective action for the product Sydney IVF PVP, William A. Cook Australia Pty Ltd. PDF, 58KB, File does not meet accessibility standards Date: 25. November 2015 Topics: Medical devices Type: Customer information

Product group Physical therapy - others
Reference 07714/15

Corrective action for the Valve XS Atrium Lift Retractor Blades, Aesculap AG PDF, 300KB, File does not meet accessibility standards Date: 25. November 2015 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - cardiac/thorax surgery
Reference 08119/15

Urgent Safety Notice for the BD Plastipack™ Syringes and BD™ Oral-Syringes (included in the Kit packs), Lohmann & Rauscher GmbH & Co KG PDF, 18KB, File does not meet accessibility standards Date: 25. November 2015 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - syringes and cannulas
Reference 06769/15, 06769A/15