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Urgent Safety Notice for the product: MOSAIQ (Version 2.41 and higher), IMPAC Medical Systems, Inc. PDF, 37KB, File does not meet accessibility standards Date: 14. July 2015 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 04086/15

Sulfasalazine/Sulfapyridine-Drug Interference, Roche Diagnostics PDF, 141KB, File does not meet accessibility standards Date: 14. July 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 03633/15

Safety Update for e.cam regarding unintended mechanical motion, Siemens Medical Solutions USA, Inc. PDF, 731KB, File does not meet accessibility standards Date: 14. July 2015 Topics: Medical devices Type: Customer information

Product group Radiological technology - equipment for nuclear medical functional and localisation diagnostics
Reference 04131/15

Corrective action for the Volcano S5 and Core Family with SW version 3.3/3.4, Volcano Corporation PDF, 201KB, File does not meet accessibility standards Date: 14. July 2015 Topics: Medical devices Type: Customer information

Product group Radiological technology - auxiliary equipment and supplies for radiology / nuclear medicine
Reference 04146/15

Recall for the Symed Laryngoscope Handles, preOx.RS GmbH PDF, 58KB, File does not meet accessibility standards Date: 14. July 2015 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - medical microscopes (does not incude laboratory microscopes)
Reference 03950/15

Corrective action for the Efficia DFM100 Defibrillator/Monitor, Philips Healthcare PDF, 146KB, File does not meet accessibility standards Date: 14. July 2015 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 04194/15

Recall for the LEXA® femoral components, C2F IMPLANTS PDF, 747KB, File does not meet accessibility standards Date: 14. July 2015 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 06371/14

Recall for the Thoracic Vent Procedure Tray, Uresil, LLC PDF, 2MB, File does not meet accessibility standards Date: 13. July 2015 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - drainages and suction systems
Reference 04009/15

Recall for the Gyrus ACMI Diego Elite Tubeset, GYRUS ACMI, Inc. (Olympus) PDF, 29KB, File does not meet accessibility standards Date: 13. July 2015 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 03001/15

Urgent Safety Notice for the Omnis system, Dako Denmark A/S PDF, 225KB, File does not meet accessibility standards Date: 13. July 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 02341/15

Urgent Safety Notice for the Heart Reference Sensor (Model Number EVHRS) / ClearSight System, Edwards Lifesciences PDF, 30KB, File does not meet accessibility standards Date: 13. July 2015 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 03571/15

Follow-Up / Safety Notice for the Puritan Bennett™ 980 Series Ventilator System, Covidien PDF, 110KB, File does not meet accessibility standards Date: 13. July 2015 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 00703/15

Corrective action for the products rHead, uHead, Sigmoid Notch, ReMotion, Radio Capitellum, Stryker Trauma AG - Division Trauma and Extremities PDF, 422KB, File does not meet accessibility standards Date: 09. July 2015 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 03689/15

Corrective action for the Hudson RCI® SHERIDAN SHER-I-BRONCH® Endobronchial Tube, Teleflex Medical PDF, 113KB, File does not meet accessibility standards Date: 09. July 2015 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 01074/15

Recall for the OptiSplint Endoprosthesis, optimed Medizinische Instrumente GmbH PDF, 209KB, File does not meet accessibility standards Date: 09. July 2015 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 04108/15

Information regarding Mitroflow Model 12, LXA and DL, Sorin Group Canada, Inc. PDF, 300KB, File does not meet accessibility standards Date: 09. July 2015 Topics: Medical devices Type: Customer information

Product group Non-active implants - cardiac surgery
Reference 03358/15

Urgent Safety Notice for the Sonialvision Safire 17 Radiographic System, SHIMADZU Corporation PDF, 73KB, File does not meet accessibility standards Date: 09. July 2015 Topics: Medical devices Type: Customer information

Product group Radiological technology - CT scanners
Reference 03309/15

Corrective action for the nMARQ® Circular Irrigated Catheter, Biosense Webster PDF, 1MB, File does not meet accessibility standards Date: 09. July 2015 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 03971/15

Corrective action for the Prelude® Sheath Introducer, Merit Medical Systems, Inc. PDF, 254KB, File does not meet accessibility standards Date: 09. July 2015 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 03893/15

Urgent Safety Notice for the M-Biopsy™ Coaxial lntroducer Needle, Mermaid Medical A/S PDF, 3MB, File does not meet accessibility standards Date: 08. July 2015 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - gynaecology
Reference 04048/15

Urgent Safety Notice for the product Assy, 2mm and 4mm Offset Femoral Alignment Locating Guide Revision Femur, OMNI PDF, 7MB, File does not meet accessibility standards Date: 08. July 2015 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 03839/15

Urgent Safety Notice for the Etest® CEFOTAXIME CT 256, BioMérieux SA PDF, 323KB, File does not meet accessibility standards Date: 08. July 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 03817/15

Corrective action for the Abbott Clinical Chemistry Alkaline Wash, Abbott Diagnostics PDF, 20KB, File does not meet accessibility standards Date: 08. July 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 03184/15

Corrective action for Precision 500D, Precision Rxi and Precision MPi X-ray imaging systems (Single and dual LCD monitor suspensions), GE Healthcare PDF, 330KB, File does not meet accessibility standards Date: 08. July 2015 Topics: Medical devices Type: Customer information

Product group Radiological technology - stationary radiological equipment
Reference 04065/15

Corrective action for Artis systems, Siemens Healthcare PDF, 5MB, File does not meet accessibility standards Date: 08. July 2015 Topics: Medical devices Type: Customer information

Product group Radiological technology
Reference 05300/13

Recall of Surgical Clipper Charger base, Medline Industries Inc. PDF, 226KB, File does not meet accessibility standards Date: 08. July 2015 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 04034/15

Urgent Safety Notice for the CyberKnife® Robotic Radiosurgery System, Accuray PDF, 37KB, File does not meet accessibility standards Date: 08. July 2015 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 07842/14

Corrective action for the product 3M™ ESPE™ Lava™ Ultimate CAD/CAM Restorative, 3M ESPE Dental PDF, 22KB, File does not meet accessibility standards Date: 07. July 2015 Topics: Medical devices Type: Customer information

Product group Dental products - dental material
Reference 03904/15

Corrective action for the MobileDiagnost wDR 1 und 2, Philips Medical Systems PDF, 241KB, File does not meet accessibility standards Date: 07. July 2015 Topics: Medical devices Type: Customer information

Product group Radiological technology - stationary radiological equipment
Reference 04021/15

Urgent Safety Notice/Update for the Expel™ APD and APDL Drainage Catheters, Boston Scientific PDF, 213KB, File does not meet accessibility standards Date: 07. July 2015 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - drainages and suction systems
Reference 01209/15