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Safety notice for insulin pumps DANA Diabecare IIS, Sooil Development Co. Ltd PDF, 727KB, File does not meet accessibility standards Date: 16. December 2013 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 02825/13

Safety Notice concerning the Hamilton-C2 ventilator, Hamilton Medical PDF, 2MB, File does not meet accessibility standards Date: 16. December 2013 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 05825/13

Safety Notice for Surgical Kits about the change of sterilization instructions, BIOMET 3i PDF, 119KB, File does not meet accessibility standards Date: 16. December 2013 Topics: Medical devices Type: Customer information

Product group Dental products - dental implants
Reference 06464/13

Safety Notice concerning the Puritan Bennett™ 840 ventilator, Covidien PDF, 152KB, File does not meet accessibility standards Date: 16. December 2013 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 07326/13

Safety Notice concerning Eclipse™ Treatment Planning System, ARIA® Radiation Oncology, ARIA®Radiation Therapy Management, and Acuity™, Varian medical systems PDF, 32KB, File does not meet accessibility standards Date: 16. December 2013 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 07371/13

Safety Notice for the Basin Liner within Mölnlycke ProcedurePak®, Mölnlycke Health Care PDF, 342KB, File does not meet accessibility standards Date: 16. December 2013 Topics: Medical devices Type: Customer information

Product group Dressings / Pads - others
Reference 05954/13

Safety Notice concerning DRX-Evolution and KODAK DirectView X-ray systems, Carestream Health PDF, 18KB, File does not meet accessibility standards Date: 16. December 2013 Topics: Medical devices Type: Customer information

Product group Radiological technology - stationary radiological equipment
Reference 07207/13

Recall for the Drill Templates and Saw Guides for LCP-Ulna-Osteotomyplates 2.7, Synthes GmbH PDF, 65KB, File does not meet accessibility standards Date: 16. December 2013 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 06986/13

Recall Removal of the Vessix™ Generator System, Boston Scientific Corp. PDF, 158KB, File does not meet accessibility standards Date: 16. December 2013 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 06855/13

Safety Notice for Dialox 10 kg, Bioxal SA PDF, 2MB, File does not meet accessibility standards Date: 16. December 2013 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - cleaning / disinfection / sterilisation
Reference 06290/13

Safety Notice for VitreaCore software versions 6.0, 6.1, 6.2, 6.3 (except 6.3.1), 6.4 (except 6.4.4 and 6.4.5), as well as their upgrades, and 6.5, Vital Images, Inc. PDF, 436KB, File does not meet accessibility standards Date: 13. December 2013 Topics: Medical devices Type: Customer information

Product group Radiological technology - auxiliary equipment and supplies for radiology / nuclear medicine
Reference 06413/13

Safety Notice for STERRAD® 200, ASP (Advanced Sterilization Products) PDF, 79KB, File does not meet accessibility standards Date: 13. December 2013 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - cleaning / disinfection / sterilisation
Reference 05580/13

Recall for HT Connect Peripheral Guide Wires, Abbott Vascular PDF, 457KB, File does not meet accessibility standards Date: 13. December 2013 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 07077/13

Safety Notice for STERRAD® NX 100, ASP (Advanced Sterilization Products) PDF, 31KB, File does not meet accessibility standards Date: 13. December 2013 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - cleaning / disinfection / sterilisation
Reference 06344/13

Urgent Safety Notice for certain Karl Storz fiberscopes in STERRAD® Systems, Karl Storz PDF, 29KB, File does not meet accessibility standards Date: 13. December 2013 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - cleaning / disinfection / sterilisation
Reference 06902/13

Recall for the Firebird Spinal Fixation System Modular Screwdriver, Orthofix PDF, 391KB, File does not meet accessibility standards Date: 13. December 2013 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 07170/13

Safety Information for Elekta Precise Tables™ range 124001 to 126924, 133801 to 133999, 213000 to 213398, 227001 to 227144. PDF, 406KB, File does not meet accessibility standards Date: 13. December 2013 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - others
Reference 01324/13

Second Safety Notice for the Cadisc™-C Endplate Handles and Blades, Ranier Technology Limited PDF, 210KB, File does not meet accessibility standards Date: 13. December 2013 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 07151/12

Safety Notice for the HeartStart FRx or HeartStart HS1 automated external defibrillators (AEDs), Philips Healthcare PDF, 47KB, File does not meet accessibility standards Date: 13. December 2013 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 07471/13

Safety Notice for all 3DLINE DMLC systems on an Elekta digital accelerator, Elekta PDF, 256KB, File does not meet accessibility standards Date: 13. December 2013 Topics: Medical devices Type: Customer information

Product group Radiological technology - equipment for nuclear medical functional and localisation diagnostics
Reference 04902/13

Safety Notice for DMLC systems on an Elekta digital accelerator, Elekta PDF, 257KB, File does not meet accessibility standards Date: 13. December 2013 Topics: Medical devices Type: Customer information

Product group Radiological technology - equipment for nuclear medical functional and localisation diagnostics
Reference 04902/13

Corrective action for BBL MGIT Mycobacteria Growth Indicator Tubes, Becton Dickinson PDF, 59KB, File does not meet accessibility standards Date: 13. December 2013 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 05503/13

Safety Notice for overhead Video Monitor Suspension of Precision 500D, Legacy, Prestilix, Monitrol, RFX, SFX, Tilt-C, Prestige VH, Prestige SI and Prestige SII X-ray systems, GE Healthcare PDF, 89KB, File does not meet accessibility standards Date: 13. December 2013 Topics: Medical devices Type: Customer information

Product group Radiological technology - stationary radiological equipment
Reference 07171/13

Safety Notice concerning EPIQ 7 Ultrasound systems with software version 1.0 and 1.0.1, Philips Healthcare PDF, 57KB, File does not meet accessibility standards Date: 12. December 2013 Topics: Medical devices Type: Customer information

Product group Ultrasonics - ultrasonic diagnostic equipment
Reference 06749/13

Recall for Alere Triage® Troponin I,Alere PDF, 62KB, File does not meet accessibility standards Date: 12. December 2013 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 06837/13

Corrective Action for the ABL90FLEX Analyzers, Radiometer PDF, 30KB, File does not meet accessibility standards Date: 12. December 2013 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 06492/13

Recall of BD Sabouraud Agar with Gentamycin and Chloramphenicol, Becton Dickinson PDF, 73KB, File does not meet accessibility standards Date: 12. December 2013 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 06636/13

Recall for i-STAT PT/INR cartridge, Abbott PDF, 57KB, File does not meet accessibility standards Date: 12. December 2013 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 06512/13

Recall of several lots of COBE® Spectra Apheresis System Disposable tubing sets FSN BCT8, Terumo PDF, 100KB, File does not meet accessibility standards Date: 12. December 2013 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - equipment for collecting blood products and peripheral stem cells
Reference 05955/13

Corrective action for the BFT II Analyzer, Siemens PDF, 25KB, File does not meet accessibility standards Date: 12. December 2013 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 06653/13