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Safety Notice / Lot Recall for the products DRYSTAR DT2 MAMMO and DRYSTAR DT5.000I MAMMO, Agfa Healthcare PDF, 82KB, File does not meet accessibility standards Date: 11. April 2012 Topics: Medical devices Type: Customer information

Product group Radiological technology - radiological equipment for mammographic diagnostics
Reference 02177/12

Safety Notice for for DX-D 10G, DX-D 10C, DX-D 20G and DX-D 20C digital detectors, AGFA Healthcare PDF, 47KB, File does not meet accessibility standards Date: 11. April 2012 Topics: Medical devices Type: Customer information

Product group Radiological technology - stationary radiological equipment
Reference 01702/12

Lot Recall for the product Biomet Bone Zement V, BIOMET PDF, 169KB, File does not meet accessibility standards Date: 10. April 2012 Topics: Medical devices Type: Customer information

Product group Non-active implants - materials for implants
Reference 01101/12

Lot Recall for CollaGuide, KENSAY NASH PDF, 265KB, File does not meet accessibility standards Date: 10. April 2012 Topics: Medical devices Type: Customer information

Product group Dental products - others
Reference 01834/12

Safety Notice for CAMERON HEALTH SQ RX Pulse Generator, model number 1010 PDF, 52KB, File does not meet accessibility standards Date: 10. April 2012 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - defibrillators
Reference 02309/12

Safety Notice concerning Precedence and SKYLight SPECT Systems, Philips Healthcare PDF, 31KB, File does not meet accessibility standards Date: 10. April 2012 Topics: Medical devices Type: Customer information

Product group Radiological technology - equipment for nuclear medical functional and localisation diagnostics
Reference 01966/12

Safety Notice for the 4D Integrated Treatment Console (4DITC), Varian medical systems PDF, 232KB, File does not meet accessibility standards Date: 10. April 2012 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 02142/12

Recall of CardioFocus Endoscopic Ablation System (EAS) – HeartLight Catheters Lots 7957, 7975, 8006 and 8011, CardioFocus, Inc. PDF, 203KB, File does not meet accessibility standards Date: 10. April 2012 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 01723/12

Urgent Safety Notice for the Thoratec HeartMate II LVAS, Thoratec Corp. PDF, 724KB, File does not meet accessibility standards Date: 05. April 2012 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - artificial hearts
Reference 01160/12

CE certificate of conformity of Syneron Dental Lasers LiteTouch temporarily suspended, Light Instruments Ltd. PDF, 26KB, File does not meet accessibility standards Date: 05. April 2012 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - laser technology
Reference 00459/12

Safety Notice for the 52-leaf Standard MLC and 52-leaf Millenium MLC, Varian medical systems PDF, 2MB, File does not meet accessibility standards Date: 05. April 2012 Topics: Medical devices Type: Customer information

Product group Radiological technology - equipment for nuclear medical functional and localisation diagnostics
Reference 01956/12

Safety Notice for the EVG Videogastroskop ENDOMED-DUO and EVC 21-37 Videocoloskop ENDOMED-DUO, ESCAD PDF, 185KB, File does not meet accessibility standards Date: 05. April 2012 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - endoscopes
Reference 01352/12

Safety Notice concerning IntelliSpace Portal with software version V4.0, Philips Healthcare PDF, 270KB, File does not meet accessibility standards Date: 04. April 2012 Topics: Medical devices Type: Customer information

Product group Radiological technology - CT scanners
Reference 01919/12

Corrective Action for i-STAT cTnI cartridges, Abbott PDF, 59KB, File does not meet accessibility standards Date: 04. April 2012 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 01701/12

Recall for Antimicrobial Susceptibility Testing Disc SXT 25, Oxoid PDF, 36KB, File does not meet accessibility standards Date: 04. April 2012 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 01661/12

Recall for the Gangi Special-Vertebroplasty Needle Set for Cemento-RE, OptiMed Medizinische Instrumente PDF, 189KB, File does not meet accessibility standards Date: 04. April 2012 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 02040/12

Lot Recall for the Brillant Mouth Mirror, HAGER & WERKEN PDF, 45KB, File does not meet accessibility standards Date: 03. April 2012 Topics: Medical devices Type: Customer information

Product group Dental products - instruments
Reference 02087/12

Safety Notice for the Cadisc™ Distractors, Ranier Technology Limited PDF, 1MB, File does not meet accessibility standards Date: 03. April 2012 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 01812/12

Recall for Combo Reamer Drills, Stryker Osteosynthesis PDF, 84KB, File does not meet accessibility standards Date: 03. April 2012 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 01984/12

Lot Recall of the “M.R.I. Implanted Port“ port system, BARD PDF, 175KB, File does not meet accessibility standards Date: 02. April 2012 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 01040/12

Corrective Action for AxSYM Free T4 Standard Calibrators, Abbott PDF, 29KB, File does not meet accessibility standards Date: 02. April 2012 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 00925/12

Batch recall of ECHOLON 60 ENDOPATH STAPLER Endoscopic Linear Cutter (Straight; EC60, SC60, LONG 60), Ethicon Endo-Surgery PDF, 611KB, File does not meet accessibility standards Date: 30. March 2012 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - general instruments
Reference 01839/12

Recall of AltaFlow Measuring Catheters, OptiMed PDF, 5MB, File does not meet accessibility standards Date: 30. March 2012 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 01841/12

Information for gauze products with x-ray thread, Karl Beese PDF, 1MB, File does not meet accessibility standards Date: 28. March 2012 Topics: Medical devices Type: Customer information

Product group Dressings / Pads - swabs, sponges, wipes, swabsticks
Reference 02015/12

Safety Notice for PROCARE Monitors B20 or B40, GE Healthcare PDF, 60KB, File does not meet accessibility standards Date: 28. March 2012 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 01075/12

Safety Notice for Intellivue Patient Monitors, Philips PDF, 46KB, File does not meet accessibility standards Date: 28. March 2012 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 01100/12

Incorrect SUV values (Standardized Uptake Value) displayed in Brilliance Workspace Portal, Philips PDF, 90KB, File does not meet accessibility standards Date: 28. March 2012 Topics: Medical devices Type: Customer information

Product group Radiological technology - CT scanners
Reference 01817/11

Recall of Fenestrated Screw Open Alignment Guide, DePuy Spine PDF, 103KB, File does not meet accessibility standards Date: 28. March 2012 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 01773/12

Corrective Action for Galileo Echo due to defective temperature sensor, Immucor PDF, 28KB, File does not meet accessibility standards Date: 28. March 2012 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 01766/12

Lot recall of 12 Fr SLS II Laser sheaths, Spectranetics Corporation PDF, 112KB, File does not meet accessibility standards Date: 28. March 2012 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 01749/12