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Corrective action on certain Puritan Bennett 840 ventilators containing a particular power supply unit, Covidien PDF, 37KB, File does not meet accessibility standards Date: 02. July 2014 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 03319/14

Corrective action concerning the STERRAD® 100S sterilization process of Anspach products, Synthes GmbH PDF, 10MB, File does not meet accessibility standards Date: 02. July 2014 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 03334/14

Urgent Safety Notice for the Digital Radiography X-Ray System DX-D 100, Agfa HealthCare PDF, 26KB, File does not meet accessibility standards Date: 02. July 2014 Topics: Medical devices Type: Customer information

Product group Radiological technology - stationary radiological equipment
Reference 03233/14

Corrective action for the CARESCAPE Monitor B650, GE Healthcare PDF, 70KB, File does not meet accessibility standards Date: 02. July 2014 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 03603/14

Corrective action for the Kodak DirectView DR 9000 System, Carestream Health, Inc. PDF, 29KB, File does not meet accessibility standards Date: 01. July 2014 Topics: Medical devices Type: Customer information

Product group Radiological technology - stationary radiological equipment
Reference 03337/14

Corrective action for the MatrixRIB™ Fixation System (T-Plate 2.0 mm), Synthes GmbH PDF, 2MB, File does not meet accessibility standards Date: 01. July 2014 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 03524/14

Corrective action for the Intuitive Surgical Large Clip Applier for use with the da Vinci® S™ and da Vinci® Si™, Intuitive Surgical, Inc. PDF, 230KB, File does not meet accessibility standards Date: 01. July 2014 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 03599/14

Corrective action for the ADVIA Centaur® TNI-Ultra ReadyPacks®, Siemens Healthcare Diagnostics PDF, 38KB, File does not meet accessibility standards Date: 01. July 2014 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 03226/14

Recall for the products Cardioxyl®, Cardioflon® Evolution und Surgikit®, Péters Surgical PDF, 179KB, File does not meet accessibility standards Date: 01. July 2014 Topics: Medical devices Type: Customer information

Product group Dressings / Pads - surgical sutures, vascular loops etc.
Reference 03529/14

Zimmer: Recall for specific lots of the NexGen Complete Knee Solution MIS Total Knee Procedure Stemmed Tibial Component, Precoat, various sizes PDF, 339KB, File does not meet accessibility standards Date: 30. June 2014 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 03533/14

Corrective action for the Waterlase iPlus Dental Laser System (Software version 1.7), Biolase Inc./Biolase Europe GmbH PDF, 102KB, File does not meet accessibility standards Date: 30. June 2014 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - laser technology
Reference 03383/14

Corrective action for the DuraDiagnost X-ray system, Philips Healthcare PDF, 57KB, File does not meet accessibility standards Date: 30. June 2014 Topics: Medical devices Type: Customer information

Product group Radiological technology - stationary radiological equipment
Reference 03544/14

Urgent Safety Notice for the Digital Radiography X-Ray System DX-D 100, Agfa HealthCare NV PDF, 69KB, File does not meet accessibility standards Date: 30. June 2014 Topics: Medical devices Type: Customer information

Product group Radiological technology - stationary radiological equipment
Reference 03451/14

Corrective action for the Tytin Regular Set, Kerr Corporation PDF, 164KB, File does not meet accessibility standards Date: 30. June 2014 Topics: Medical devices Type: Customer information

Product group Dental products - dental material
Reference 03166/14

Synthes GmbH: Corrective action/Recall for the Cortex Screw, self-tapping, length 8 mm Ø 1.3 and 1.5 mm, sterile and non-sterile PDF, 285KB, File does not meet accessibility standards Date: 27. June 2014 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 03346/14

Additional Information for the Altrus® Thermal Tissue Fusion Handpieces, ConMed PDF, 99KB, File does not meet accessibility standards Date: 27. June 2014 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 00953/14

Stop of use for the products i-Visc ® 1.0, 1.4, 1.6 Sodium Hyaluronate and i-Visc ® 2.0 Hydroxypropyl Methylcellulose, i-Medical Ophthalmic International Heidelberg GmbH PDF, 109KB, File does not meet accessibility standards Date: 27. June 2014 Topics: Medical devices Type: Customer information

Product group ophthalmological technology - liquid media for ophthalmological purposes
Reference 00710/14

Recall for the HydroFinity™ Guidewires, Covidien PDF, 37KB, File does not meet accessibility standards Date: 26. June 2014 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 03266/14

Corrective action for PRISMA and PRISMAFLEX sets, Gambro Industries PDF, 1MB, File does not meet accessibility standards Date: 26. June 2014 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - dialysis technology
Reference 03416/14

Updated Information/Corrective action for the Architect Intact PTH Assay, Abbott PDF, 182KB, File does not meet accessibility standards Date: 26. June 2014 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 00753/14

Corrective action for Gel-E Donut and Squishon 2 gel-filled products, Philips/Children’s Medical Ventures PDF, 92KB, File does not meet accessibility standards Date: 26. June 2014 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology - daily living aids
Reference 03210/14

Corrective action concerning Cover 15+25mm for acetabular cup, Stemcup Medical Products AG PDF, 1MB, File does not meet accessibility standards Date: 26. June 2014 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 03089/14

Corrective action for the Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX, GE Healthcare PDF, 73KB, File does not meet accessibility standards Date: 25. June 2014 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 03364/14

Corrective action for the Philips MobileDiagnost wDR X-ray systems, Philips Medical Systems PDF, 36KB, File does not meet accessibility standards Date: 25. June 2014 Topics: Medical devices Type: Customer information

Product group Radiological technology - stationary radiological equipment
Reference 02684/14

Corrective action for the EmbryoScope time-lapse incubator, Unisense FertiliTech A/S PDF, 573KB, File does not meet accessibility standards Date: 25. June 2014 Topics: Medical devices Type: Customer information

Product group In vitro fertilization - others
Reference 03193/14

Corrective action for the CMF Drill Bit with Stop, Synthes GmbH PDF, 118KB, File does not meet accessibility standards Date: 25. June 2014 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 03345/14

Corrective action for the IntelliVue MX40 patient monitor with software revisions B.00 and B.01, Philips Healthcare PDF, 195KB, File does not meet accessibility standards Date: 24. June 2014 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 03450/14

Recall for the Langston V2 Dual Lumen Catheter, Vascular Solutions, Inc. PDF, 190KB, File does not meet accessibility standards Date: 24. June 2014 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 03191/14

Corrective action for the CT Exprès™ contrast media injection system, Bracco Injeneering S.A. PDF, 1MB, File does not meet accessibility standards Date: 24. June 2014 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 03194/14

Safety Notice / Validated sterilization instructions for the product Reusable Temperature Probe, Measurement Specialties, Inc. PDF, 2MB, File does not meet accessibility standards Date: 24. June 2014 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 01805/14