BfArM - Federal Institute for Drugs and Medical Devices

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Information concerning the Contak Renewal 3 and 4, Vitality and Vitality 2 defibrillators from Boston Scientific PDF, 80KB, File does not meet accessibility standards Date: 24. April 2007 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices
Reference 01155/07

Information concerning the Contak Renewal 4 RF and 4 RF HE Defibrillators from Boston Scientific PDF, 84KB, File does not meet accessibility standards Date: 24. April 2007 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices
Reference 01153/07

Information concerning the Level 1 from Smiths Medical PDF, 105KB, File does not meet accessibility standards Date: 24. April 2007 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis
Reference 01001/07

Problems with the MR images from Accuray PDF, 30KB, File does not meet accessibility standards Date: 24. April 2007 Topics: Medical devices Type: Customer information

Product group Radiological technology
Reference 01126/07

Suspension of usage of all medical devices of Shelhigh PDF, 227KB, File does not meet accessibility standards Date: 20. April 2007 Topics: Medical devices Type: Customer information

Product group Non-active implants
Reference 01292/07

Recall of the lot number 07B1292050 of the stopcock Discifix C from B.Braun PDF, 42KB, File does not meet accessibility standards Date: 20. April 2007 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis
Reference 01248/07

Safety information for the emergency carriage Calypso and Calypso GT Plaster Table from Trumpf Medizinsysteme PDF, 3MB, File does not meet accessibility standards Date: 19. April 2007 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment
Reference 00394/07

Corrective action and recall of the ABL800FLEX analyzers from Radiometer PDF, 85KB, File does not meet accessibility standards Date: 19. April 2007 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics
Reference 00272/07

Recall of the MicroTherapeutics SilverSpeed® .010´´ guide wires from Ev3 Neurovascular PDF, 36KB, File does not meet accessibility standards Date: 19. April 2007 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis
Reference 01191/07

Corrective action of the Troponin I-test from Ultimed PDF, 33KB, File does not meet accessibility standards Date: 19. April 2007 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics
Reference 00262/07

Recall of Proximate PPH Hemorrhoidal Circular Staplers from Ethicon Endo-Surgery PDF, 57KB, File does not meet accessibility standards Date: 18. April 2007 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans
Reference 01105/07

Corrective action of the Microgenics MAS CardioImmune XL Assayed Cardiac Marker Control from Dade Behring PDF, 76KB, File does not meet accessibility standards Date: 16. April 2007 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics
Reference 01223/07

Recall of the All-Poly Cup of the Reflection Hip System from Smith & Nephew PDF, 31KB, File does not meet accessibility standards Date: 16. April 2007 Topics: Medical devices Type: Customer information

Product group Non-active implants
Reference 01171/07

Recall of the PadPro Adult Radiotranslucent defibrillation electrodes 2516Z and 2516M from ConMed PDF, 36KB, File does not meet accessibility standards Date: 13. April 2007 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices
Reference 01066/07

Recommendation to the battery capacity of the Lifepak 20 defibrillators from Medtronic PDF, 46KB, File does not meet accessibility standards Date: 12. April 2007 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices
Reference 01152/07

Recall of the Alpha Durasul Inlays from Zimmer PDF, 31KB, File does not meet accessibility standards Date: 11. April 2007 Topics: Medical devices Type: Customer information

Product group Non-active implants
Reference 00268/07

Recall of the Durasul Alpha Insert Box from Zimmer PDF, 20KB, File does not meet accessibility standards Date: 11. April 2007 Topics: Medical devices Type: Customer information

Product group Non-active implants
Reference 00265/07

Recall of DiaPlastin from the manufacturer Diamed Date: 11. April 2007 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics
Reference 01067/07

Information concerning the catheters with iridium-192 wires from Eckert & Ziegler BEBIG PDF, 26KB, File does not meet accessibility standards Date: 11. April 2007 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection
Reference 01077/07

Recall for TDx/TDxFLx Methothrexate II Reagent of Abbott PDF, 135KB, File does not meet accessibility standards Date: 10. April 2007 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics
Reference 01119/07

Recall of the products TSV 25 Gauge High-Speed Cutter und TSV 25 Gauge High-Speed Posterior Vitrectomy Pack from Bausch & Lomb PDF, 56KB, File does not meet accessibility standards Date: 05. April 2007 Topics: Medical devices Type: Customer information

Product group ophthalmological technology
Reference 00505/07

Corrective actions concerning the OEC UroView 2800 Systems from GE Healthcare PDF, 134KB, File does not meet accessibility standards Date: 05. April 2007 Topics: Medical devices Type: Customer information

Product group Radiological technology
Reference 02784/06

Malfunction in the using of the OR table of the MAGNETOM Espree System from Siemens PDF, 75KB, File does not meet accessibility standards Date: 05. April 2007 Topics: Medical devices Type: Customer information

Product group Electromedical fields
Reference 00831/07

Information concerning the syngo Cardiac Echo Quantification feature in syngo Dynamics version 5.0 from Siemens PDF, 67KB, File does not meet accessibility standards Date: 05. April 2007 Topics: Medical devices Type: Customer information

Product group Radiological technology
Reference 00402/07

Information concerning the ICARE intraocular lense from Corneal PDF, 37KB, File does not meet accessibility standards Date: 05. April 2007 Topics: Medical devices Type: Customer information

Product group Non-active implants
Reference 00841/07

Corrective action for all IMPAX systems from Agfa PDF, 117KB, File does not meet accessibility standards Date: 05. April 2007 Topics: Medical devices Type: Customer information

Product group Radiological technology
Reference 00655/07

Information concerning the MammoDiagnost Systems from Philips PDF, 28KB, File does not meet accessibility standards Date: 05. April 2007 Topics: Medical devices Type: Customer information

Product group Radiological technology
Reference 03794/06

Information about the StarClose Vascular Closure System from Abbott PDF, 177KB, File does not meet accessibility standards Date: 04. April 2007 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans
Reference 02680/06

Recall of Suture Passer from Smith & Nephew PDF, 44KB, File does not meet accessibility standards Date: 04. April 2007 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans
Reference 00913/07

Recall of the intraocular lenses GBR/ Vivarte Myopic and Newlife/Vivarte Presbyopic from Ioltech PDF, 140KB, File does not meet accessibility standards Date: 03. April 2007 Topics: Medical devices Type: Customer information

Product group Non-active implants
Reference 00291/07