BfArM - Federal Institute for Drugs and Medical Devices

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Recall for FC 500 with CXP 2.2 Acquisition Software and FC500 MPL with MXP 2.1 Acquisition Software of Beckman Coulter PDF, 44KB, File does not meet accessibility standards Date: 19. July 2007 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics
Reference 02418/07

Information about Ortho Clinical Diagnostics Mitis2 System from Ortho PDF, 100KB, File does not meet accessibility standards Date: 19. July 2007 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics
Reference 02347/07

Information about HeartStart XL M4735 from Philips Medizinsysteme Böblingen PDF, 160KB, File does not meet accessibility standards Date: 19. July 2007 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices
Reference 02402/07

Recall of the N’Vision Application Cards Model 8870 NNB_01 (InterStim-B software) from Medtronic PDF, 262KB, File does not meet accessibility standards Date: 17. July 2007 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices
Reference 02390/07

Corrective action on the MKONA Kit (lot number 01BG) of the Privates Institut für Immunologie und Molekulargenetik PDF, 33KB, File does not meet accessibility standards Date: 17. July 2007 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics
Reference 02300/07

Recall of the NEWAY DR pacemakers from Sorin PDF, 151KB, File does not meet accessibility standards Date: 17. July 2007 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices
Reference 02181/07

Recall of the urinary collecting bags Norta Urobag S from BSN Medical PDF, 88KB, File does not meet accessibility standards Date: 17. July 2007 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology
Reference 01715/07

Information concerning the iris fixated phakic intraocular lenses Verisyse and VeriFlex from AMO (Advanced Medical Optics) PDF, 77KB, File does not meet accessibility standards Date: 17. July 2007 Topics: Medical devices Type: Customer information

Product group Non-active implants
Reference 01190/07

Information concerning possible under delivery of enteral products from Abbott PDF, 57KB, File does not meet accessibility standards Date: 17. July 2007 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis
Reference 02184/07

Safety related change of the user manual of the Legendair ventilator from Tyco Healthcare PDF, 183KB, File does not meet accessibility standards Date: 17. July 2007 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia
Reference 02195/06

Recall of the Ranger Standard Flow Disposable Blood/Fluid Warming sets from Arizant Healthcare PDF, 142KB, File does not meet accessibility standards Date: 13. July 2007 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis
Reference 02389/07

Software upgrade of the LOGIQ 3 Expert ultrasound scanner from GE Healthcare PDF, 56KB, File does not meet accessibility standards Date: 13. July 2007 Topics: Medical devices Type: Customer information

Product group Ultrasonics
Reference 01826/07

Recall of the Morcellator Cutters 12 mm for Use with RotoCut G1 System from Karl Storz GmbH & Co. KG PDF, 42KB, File does not meet accessibility standards Date: 13. July 2007 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering
Reference 01632/07

Recall of the Procedure Tray – Knochen set from Mölnlycke Healthcare PDF, 31KB, File does not meet accessibility standards Date: 12. July 2007 Topics: Medical devices Type: Customer information

Product group Dressings / Pads
Reference 02332/07

Recall of the peritoneal dialysis patient connectors PD Night Vario Plus Set, PD Night Vario Plus Paed Set and PD-Paed System from Fresenius PDF, 106KB, File does not meet accessibility standards Date: 12. July 2007 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis
Reference 02373/07

Information concerning the mobile lifts Uno and Sabina from Liko PDF, 30KB, File does not meet accessibility standards Date: 12. July 2007 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment
Reference 00354/06

Corrective action of the m2000sp und m1000 analyzers from Abbott PDF, 34KB, File does not meet accessibility standards Date: 12. July 2007 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics
Reference 02145/07

Recall of the Barcode Q-Labels from Abbott PDF, 53KB, File does not meet accessibility standards Date: 12. July 2007 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics
Reference 02375/07

Information concerning the MiniMed Paradigm® Insulin Infusion Pump from Medtronic PDF, 150KB, File does not meet accessibility standards Date: 11. July 2007 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis
Reference 01511/07

Information concerning the Provox 2 voice prosthesis from ATOS PDF, 68KB, File does not meet accessibility standards Date: 11. July 2007 Topics: Medical devices Type: Customer information

Product group Non-active implants
Reference 01782/07

Information concerning the battery capacity of the Lifepak 20 defibrillators from Medtronic PDF, 43KB, File does not meet accessibility standards Date: 10. July 2007 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices
Reference 01152/07

Corrective action of the Storz Equipment Trolleys 29003 NEAG, NAG, NEG and WGAG from Trumpf Kreuzer Medizin Systeme PDF, 41KB, File does not meet accessibility standards Date: 09. July 2007 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia
Reference 01323/07

Update of the User Manual of the Zoll M-Series defibrillators from Zoll Medical PDF, 72KB, File does not meet accessibility standards Date: 06. July 2007 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices
Reference 00002/07

Information concerning the FCR Velocity U or FUJIFILM DR Velocity Ufp devices from FUJIFILM PDF, 205KB, File does not meet accessibility standards Date: 04. July 2007 Topics: Medical devices Type: Customer information

Product group Radiological technology
Reference 01684/07

Warning regarding the Cervical Disc System from SPINAL KINETICS PDF, 22KB, File does not meet accessibility standards Date: 29. June 2007 Topics: Medical devices Type: Customer information

Product group Non-active implants
Reference 01216/07

Information concerning the Sirus Intramedullary Nail for Femur System from Zimmer PDF, 79KB, File does not meet accessibility standards Date: 28. June 2007 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans
Reference 02345/06

Information concerning the Nanoduct sweat test system from WESCOR PDF, 31KB, File does not meet accessibility standards Date: 28. June 2007 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices
Reference 01393/07

Recall of the triglyceride reagent OSR6133 from Olympus PDF, 54KB, File does not meet accessibility standards Date: 27. June 2007 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics
Reference 01579/07

Corrective action of the Lifepak 500 automated external defibrillators from Medtronic PDF, 48KB, File does not meet accessibility standards Date: 27. June 2007 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices
Reference 02185/07

Information concerning the Brilliance 40/64 CT system from Philips PDF, 166KB, File does not meet accessibility standards Date: 26. June 2007 Topics: Medical devices Type: Customer information

Product group Radiological technology
Reference 02159/07