BfArM - Federal Institute for Drugs and Medical Devices

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Recall for TruCal Homocysteine FS, TruLab Homocysteine FS Level I and TruLab Homocysteine FS Level II, DiaSys PDF, 69KB, File does not meet accessibility standards Date: 26. January 2009 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics
Reference 03167/08

Recall of Siemens Healthcare Diagnostics Diagnostics / NovaTec Immundiagnostica for Novagnost Release Kit Version 2008-08 PDF, 2MB, File does not meet accessibility standards Date: 26. January 2009 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics
Reference 04449/08

Safety Notice for F1 Dental Chair, FIMET OY PDF, 70KB, File does not meet accessibility standards Date: 26. January 2009 Topics: Medical devices Type: Customer information

Product group Dental products
Reference 00062/09

Safety Notice for ARTISTE with syngo RT Therapist Version 4.1 build 67, Siemens PDF, 92KB, File does not meet accessibility standards Date: 26. January 2009 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection
Reference 04769/08

Field Safety Notice about a problem with the power supply for Terumo APS System 1 PDF, 1MB, File does not meet accessibility standards Date: 26. January 2009 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia
Reference 01890/08

Recall of the spreader bars of the personal lift Invacare Flamingo PDF, 8MB, File does not meet accessibility standards Date: 26. January 2009 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment
Reference 00091/09

Field Safety Notice concerning increased leakage radiation from CT /e and HiSpeed X/I families of Computed Tomography systems PDF, 198KB, File does not meet accessibility standards Date: 26. January 2009 Topics: Medical devices Type: Customer information

Product group Radiological technology
Reference 00006/09

Recall of the intraocluar lenses PC 430Y Eliteseries PDF, 556KB, File does not meet accessibility standards Date: 23. January 2009 Topics: Medical devices Type: Customer information

Product group Non-active implants
Reference 04776/08

Field Safety Notice concerning digital Linear Accelerator Artiste PDF, 659KB, File does not meet accessibility standards Date: 23. January 2009 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection
Reference 04771/08

Safety Notice for the patient lifts Liko Uno, Liko Light, Viking S and Viking XS, Liko AB PDF, 418KB, File does not meet accessibility standards Date: 23. January 2009 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment
Reference 00081/09

Recall of Siemens Healthcare Diagnostics Diagnostics (Thermofisher) for Dade Lipid Control Products PDF, 506KB, File does not meet accessibility standards Date: 21. January 2009 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics
Reference 00018/09

Recall for IMMULITE 2000/2500 Digital Fluidics PC Board, Siemens PDF, 176KB, File does not meet accessibility standards Date: 20. January 2009 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics
Reference 00013/09

Recall for HMRS Humerus Head Fixed and HMRS Distal Humerus Cone, STRYKER PDF, 68KB, File does not meet accessibility standards Date: 20. January 2009 Topics: Medical devices Type: Customer information

Product group Non-active implants
Reference 03876/08

Recall for Ribbon Gauze with Vaseline 2cm x 10m and Clauden Wadding 5g, Lohmann & Rauscher PDF, 81KB, File does not meet accessibility standards Date: 20. January 2009 Topics: Medical devices Type: Customer information

Product group Dressings / Pads
Reference 00016/09

Field Safety Notice concerning X-ray systems OrbixTop and ArcoSphere PDF, 728KB, File does not meet accessibility standards Date: 19. January 2009 Topics: Medical devices Type: Customer information

Product group Radiological technology
Reference 04202/08

Recall of Bi-Polar-Heads PDF, 290KB, File does not meet accessibility standards Date: 19. January 2009 Topics: Medical devices Type: Customer information

Product group Non-active implants
Reference 00012/09

Field Safety Notice concerning development of granuloma at intrathecal catheter tips of drug delivering systems PDF, 292KB, File does not meet accessibility standards Date: 19. January 2009 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices
Reference 00321/08

Field Safety Notice concerning Artiste digital linear accelerator PDF, 545KB, File does not meet accessibility standards Date: 19. January 2009 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection
Reference 04546/08

Recall of the Convoy™ Advances Delivery Sheath Kits PDF, 871KB, File does not meet accessibility standards Date: 19. January 2009 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis
Reference 00004/09

Recall for TOTAL PSA FASTPACK, Qualigen PDF, 75KB, File does not meet accessibility standards Date: 19. January 2009 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics
Reference 03895/08

Corrective action of Roche Diagnostics Ltd. for Cobas c111 PDF, 104KB, File does not meet accessibility standards Date: 19. January 2009 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics
Reference 04282/08

Safety Notice for Minimally Invasive Technology ™ Offset Rasp Handles-30 Degree Left and Right, Zimmer PDF, 97KB, File does not meet accessibility standards Date: 19. January 2009 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans
Reference 04893/08

Recall for CELL-DYN Sapphire Hemoglobin Reagent Syringe, Abbott PDF, 38KB, File does not meet accessibility standards Date: 19. January 2009 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics
Reference 04892/08

Recall of CADD® Medication Cassette Reservoirs PDF, 954KB, File does not meet accessibility standards Date: 19. January 2009 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis
Reference 04785/08

Recall of Akreos Advanced Optics Aspheric Intra-Ocular lenses PDF, 44KB, File does not meet accessibility standards Date: 19. January 2009 Topics: Medical devices Type: Customer information

Product group Non-active implants
Reference 04778/08

Field Safety Notice for customers of the Epicor LP Cardiac Ablation System PDF, 602KB, File does not meet accessibility standards Date: 19. January 2009 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices
Reference 04634/08

Recall for Neos Vanadium Excavators, Kerr PDF, 116KB, File does not meet accessibility standards Date: 19. January 2009 Topics: Medical devices Type: Customer information

Product group Dental products
Reference 04421/08

Safety Notice for NAVISTAR RMT Catheters, Biosense Webster PDF, 69KB, File does not meet accessibility standards Date: 15. January 2009 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis
Reference 03991/08

Safety Notice for microTargeting Drive System and Accessories, Medtronic PDF, 349KB, File does not meet accessibility standards Date: 15. January 2009 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia
Reference 04819/08

Recall for MEDAP connection tubes for medical gases, Maquet PDF, 82KB, File does not meet accessibility standards Date: 15. January 2009 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia
Reference 04783/08