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Corrective action for the Oxford Femoral Drill Guide Lateral IM Adapter, Biomet Orthopedics (“Biomet”) PDF, 318KB, File does not meet accessibility standards Date: 07. July 2015 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 03790/15

Corrective action for the D-Fend/D-Fend+ water traps, GE Healthcare PDF, 176KB, File does not meet accessibility standards Date: 07. July 2015 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 04030/15

Urgent Safety Notice for the FreeStyle Libre Flash Glucose Monitoring System, Abbott Diabetes Care PDF, 247KB, File does not meet accessibility standards Date: 07. July 2015 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electric blood glucose meters
Reference 04059/15

Corrective action for the MicroScan WalkAway plus Instrument, Beckman Coulter PDF, 87KB, File does not meet accessibility standards Date: 07. July 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 03234/14

IFU update for the Cook LapSac® Surgical Tissue Pouch, Cook Incorporated, Cook Ireland Ltd. PDF, 25KB, File does not meet accessibility standards Date: 07. July 2015 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - endoscopes
Reference 03789/15, 03908/15

Safety Information/Update for the Cranial Navigation System (all versions), Brainlab PDF, 542KB, File does not meet accessibility standards Date: 06. July 2015 Topics: Medical devices Type: Customer information

Product group Radiological technology - navigation systems
Reference 02443/13

Urgent Safety Notice for the Titration Medium Solidscreen II, Bio-Rad Medical Diagnostics GmbH PDF, 50KB, File does not meet accessibility standards Date: 06. July 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 03798/15

Recall for the product respons® Bilirubin Auto Total FS, DiaSys Diagnostic Systems GmbH PDF, 95KB, File does not meet accessibility standards Date: 06. July 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 03783/15

Urgent Safety Notice for the Flexor RTPS Guiding Sheath, COOK Medical Europe PDF, 105KB, File does not meet accessibility standards Date: 06. July 2015 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 04077/15

Urgent Safety Notice for the Tetanos Quick Stick TQS®, Gamma Diaxonhit Groupe PDF, 189KB, File does not meet accessibility standards Date: 30. June 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 02096/15

Corrective action for the Philips Ultrasound Q-Station software, Philips Healthcare — Ultrasound PDF, 554KB, File does not meet accessibility standards Date: 30. June 2015 Topics: Medical devices Type: Customer information

Product group Radiological technology - auxiliary equipment and supplies for radiology / nuclear medicine
Reference 03859/15

Urgent Safety Notice for the OPTIMEDICA Catalys® Precision Laser System, OptiMedica Corporation PDF, 113KB, File does not meet accessibility standards Date: 30. June 2015 Topics: Medical devices Type: Customer information

Product group ophthalmological technology - equipment for ophthalmological therapeutics
Reference 03068/15

Corrective action for the Acetaminophen assay, Sekisui Diagnostics P.E.I. Inc. PDF, 160KB, File does not meet accessibility standards Date: 30. June 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 02965/15

Urgent Safety Notice – Easypump II Recall, B. Braun Melsungen AG PDF, 68KB, File does not meet accessibility standards Date: 30. June 2015 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 04091/15

Urgent Safety Notice for the CADD®-Solis Ambulatory Infusion Pumps, Smiths Medical ASD PDF, 171KB, File does not meet accessibility standards Date: 30. June 2015 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 03334/15

Corrective action for the PROCISE EZ View™ with Integrated Cable and EVAC™ 70 XTRA with Integrated Cable Wands, Smith & Nephew PDF, 70KB, File does not meet accessibility standards Date: 30. June 2015 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 03711/15

Corrective action for the multiFiltratePRO devices, Fresenius Medical Care PDF, 40KB, File does not meet accessibility standards Date: 30. June 2015 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - dialysis technology
Reference 03915/15

Recall for the SofPort & SoFlex intraocular lenses, Bausch + Lomb PDF, 48KB, File does not meet accessibility standards Date: 30. June 2015 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 03560/15

Urgent Safety Notice for the product RayStation, RaySearch Laboratories PDF, 486KB, File does not meet accessibility standards Date: 29. June 2015 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 03159/15

Urgent Safety Notice for the ATTUNE® INTUITION™ Tibial Articulation Surface Instruments, DePuy Orthopaedics, Inc. PDF, 703KB, File does not meet accessibility standards Date: 29. June 2015 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 03897/15

Urgent Safety Notice for Birdie Lifters, Invacare PDF, 22KB, File does not meet accessibility standards Date: 29. June 2015 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - ward equipment and equipment for emergency medical services
Reference 02613/15

Corrective action for the BIRMINGHAM HIP™ RESURFACING (BHR) SYSTEM, Smith & Nephew PDF, 116KB, File does not meet accessibility standards Date: 29. June 2015 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 03544/15

Corrective action for the Pull Reduction Device for Percutaneous Drill Guide, Synthes GmbH PDF, 1MB, File does not meet accessibility standards Date: 29. June 2015 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 04012/15

Another Safety Notice for the products VIVA II, PRISMA II and MELODY II (Sleep apnea devices), Heinen + Löwenstein GmbH & Co. KG PDF, 296KB, File does not meet accessibility standards Date: 29. June 2015 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 03800/15

Urgent Safety Notice for the power cord of the respiration device VECTOR ET, VitalAire GmbH PDF, 154KB, File does not meet accessibility standards Date: 25. June 2015 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 04003/15

Urgent Safety Notice for the Light Wand Stylet and Light Wand Introduction pack, Vital Signs (belonging to CareFusion) PDF, 54KB, File does not meet accessibility standards Date: 25. June 2015 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 04004/15

Urgent Safety Notice for the Artis/Evosys Dialysis System, Gambro Dasco S.p.A PDF, 1MB, File does not meet accessibility standards Date: 25. June 2015 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - dialysis technology
Reference 03679/15

Corrective action for the Innova, Optima and Discovery Systems, GE Healthcare PDF, 58KB, File does not meet accessibility standards Date: 25. June 2015 Topics: Medical devices Type: Customer information

Product group Radiological technology - radiological equipment for vascular diagnostics
Reference 03677/15

Corrective action for the Dimension Vista® 500 Intelligent Lab System or Dimension Vista® 1500 Intelligent Lab System using 3.6.1 software versions, Siemens Healthcare Diagnostics PDF, 31KB, File does not meet accessibility standards Date: 25. June 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 03639/15

Urgent Safety Notice for the Adaptive Servo-Ventilation (ASV) Therapy (SleepOne ProSV and SleepOne ProPSV devices), Kare Medical PDF, 373KB, File does not meet accessibility standards Date: 25. June 2015 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 03145/15