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Recall of specific lots of the EnVision™ FLEX/HRP visualization reagent, Dako PDF, 78KB, File does not meet accessibility standards Date: 09. October 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 05196/15

URGENT FIELD SAFETY NOTICE for Zimmer Natural Nail CM Long, Zimmer Biomet PDF, 106KB, File does not meet accessibility standards Date: 09. October 2015 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 06589/15

Voluntary Recall of Specific Serial Numbers of ConforMIS Knee Replacement Systems, ConforMIS PDF, 144KB, File does not meet accessibility standards Date: 08. October 2015 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 06345/15

Urgent Field Safety Notice for syngo® Lab Data Manager, Siemens Healthcare Diagnostics Inc. PDF, 39KB, File does not meet accessibility standards Date: 08. October 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 06411/15

Urgent Field Safety Notice for Liko® Viking® L, Viking® M, Viking® XL, and Viking® 300 Mobile Lifts, Hill-Rom PDF, 726KB, File does not meet accessibility standards Date: 08. October 2015 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - ward equipment and equipment for emergency medical services
Reference 04082/15

IMPORTANT FIELD SAFETY NOTICE, Dose and MU Incorrect, Product Monaco, Elekta PDF, 113KB, File does not meet accessibility standards Date: 08. October 2015 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 06444/15

URGENT FIELD SAFETY NOTICE for BD Vacutainer® Eclipse TM Signal™ Blood Collection Needle
with lntegrated Holder, Becton, Dickinson U.K.Limited
PDF, 2MB, File does not meet accessibility standards
Date: 08. October 2015 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - syringes and cannulas
Reference 06158/15

URGENT FIELD SAFETY NOTICE for BD Affirm VPIII Microbial Identification Tests, Becton Dickinson France S.A.S. Belgian Branch PDF, 71KB, File does not meet accessibility standards Date: 08. October 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 06252/15

lmportant customer safety notice for AXIOM Artis FA, FC, dFA, dFC, dFCM,
AXIOM Artis BA, BC, dBA, dBC, dBCM and AXIOM Artis MP, dMP Systems with SW version VB23N/P, Siemens Healthcare GmbH
PDF, 4MB, File does not meet accessibility standards
Date: 08. October 2015 Topics: Medical devices Type: Customer information

Product group Radiological technology - radiological equipment for vascular diagnostics
Reference 06393/15

Urgent Field Safety Notice for mylife OmniPod Insulin Management System PDF, 73KB, File does not meet accessibility standards Date: 08. October 2015 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 06105/15

Medical Device Recall for Sciatic Nerve Retractors PDF, 2MB, File does not meet accessibility standards Date: 08. October 2015 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 06423/15

Installing a second EO Sensor for Low Temperature Sterilizer, DMB Apparatebau GmbH PDF, 519KB, File does not meet accessibility standards Date: 07. October 2015 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - cleaning / disinfection / sterilisation
Reference 06220/15

Recall for the Target Coils, Stryker Neurovascular PDF, 99KB, File does not meet accessibility standards Date: 21. September 2015 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 05768/15

Urgent Safety Notice for MATResponder Tourniquet, Pyng Medical Corp. PDF, 43KB, File does not meet accessibility standards Date: 21. September 2015 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - medico-mechanical devices
Reference 06293/15

Safety Notice for the KIMVENT* Closed Suction Systems, Halyard Health PDF, 295KB, File does not meet accessibility standards Date: 21. September 2015 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 06136/15

Safety Notice for the Brilliance 64 and Ingenuity CT Scanners, Philips Healthcare PDF, 55KB, File does not meet accessibility standards Date: 21. September 2015 Topics: Medical devices Type: Customer information

Product group Radiological technology - CT scanners
Reference 06356/15

Safety Notice regarding MCS-Port Obturator / MCS5000, A. M. I. Agency for Medical Innovations GmbH PDF, 66KB, File does not meet accessibility standards Date: 21. September 2015 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 06611/15

Recall for the Aliquot Delivery Kits (Syringe and Plunger), Stryker® Orthobiologics PDF, 55KB, File does not meet accessibility standards Date: 21. September 2015 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - auxiliary equipment
Reference 06209/15

Safety Corrective Action/Recall for PORT-A-CATH® Plastic Hub Needles, Smiths Medical PDF, 242KB, File does not meet accessibility standards Date: 21. September 2015 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - injection kits
Reference 06681/15

Important Safety Notice for the XiO RTP System, IMPAC Medical Systems, Inc. PDF, 35KB, File does not meet accessibility standards Date: 21. September 2015 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 06197/15

Important Information for the Accu-Chek Insight system, Roche Diabetes Care PDF, 200KB, File does not meet accessibility standards Date: 21. September 2015 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 05446/15

Corrective action for the Valved Entry Systems sold as stand-alone, within CONSTELLATION® TOTALPLUS® Paks, and within Alcon CUSTOM-PAKS, Alcon Laboratories Inc. PDF, 130KB, File does not meet accessibility standards Date: 21. September 2015 Topics: Medical devices Type: Customer information

Product group ophthalmological technology - equipment for ophthalmological therapeutics
Reference 05402/15

Recall for the ThruPort™ Knot Pusher Model KP1 and Valve Placement Pack Model VPP, Edwards Lifesciences LLC PDF, 52KB, File does not meet accessibility standards Date: 16. September 2015 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - cardiac/thorax surgery
Reference 06311/15

Recall for the Actifuse ABX, Actifuse MIS System and Inductigraft products, Baxter Healthcare Corporation PDF, 175KB, File does not meet accessibility standards Date: 16. September 2015 Topics: Medical devices Type: Customer information

Product group Non-active implants - materials for implants
Reference 06062/15

Corrective action for the iChemVELOCITY Urine Chemistry Strips, Iris International PDF, 199KB, File does not meet accessibility standards Date: 16. September 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 05794/15

Urgent Safety Notice for the Neptune® 2 Docker (STRYKER NEPTUNE® 2 WASTE MANAGEMENT SYSTEM), Stryker Instruments PDF, 454KB, File does not meet accessibility standards Date: 16. September 2015 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 05963/15

Recall for the Idylla™ KRAS Mutation Test, Biocartis PDF, 3MB, File does not meet accessibility standards Date: 16. September 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 04931/15

Urgent Safety Notice for the Digital Radiography X-Ray Systems DR 400, Agfa Healthcare N.V. PDF, 35KB, File does not meet accessibility standards Date: 16. September 2015 Topics: Medical devices Type: Customer information

Product group Radiological technology - stationary radiological equipment
Reference 06049/15

Recall for the product Genu Arexa, Otto Bock HealthCare GmbH PDF, 241KB, File does not meet accessibility standards Date: 15. September 2015 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology - orthoses
Reference 06029/15

Urgent Safety Notice for the Medtronic CryoConsole, Medtronic PDF, 42KB, File does not meet accessibility standards Date: 15. September 2015 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 06259/15