BfArM - Federal Institute for Drugs and Medical Devices

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14,972 results

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Recall of Silo Bags for the treatment of gastroschisis, Medicina PDF, 258KB, File does not meet accessibility standards Date: 20. May 2016 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - endoscopes
Reference 04085/16

Urgent field safety notice for Osseofix sterile package implant 5.5 mm, Alphatec Spine Inc. PDF, 536KB, File does not meet accessibility standards Date: 20. May 2016 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 02191/16

Lot recall for Flexible Shaft Ø 8.0 mm / L 360 mm for extraction system for solid medullary nails, Synthes GmbH / DePuy Synthes PDF, 258KB, File does not meet accessibility standards Date: 20. May 2016 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 04263/16

Urgent field safety notice for bellavista ventilator, imtmedical ag. PDF, 37KB, File does not meet accessibility standards Date: 20. May 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 03098/16

Urgent field safety notice for LightSheer DESIRE, Lumenis Ltd. PDF, 204KB, File does not meet accessibility standards Date: 20. May 2016 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - laser technology
Reference 01933/16

Urgent field safety notice for Dialog+ Dialysis Machines with Software version 9.15 and 9.16, B. Braun PDF, 40KB, File does not meet accessibility standards Date: 19. May 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - dialysis technology
Reference 03903/16

Urgent field safety notice for Teosyal Ultimate and Teosyal PureSense Ultimate, TEOXANE S.A. PDF, 20KB, File does not meet accessibility standards Date: 19. May 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - materials for implants
Reference 04197/16

Lot recall of insertion instrument Primaro Cup and Primaro Cup MIS, OHST Medizintechnik AG PDF, 307KB, File does not meet accessibility standards Date: 19. May 2016 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 04160/16

Lot recall of VELOX 3 cc, InnoTERE GmbH PDF, 86KB, File does not meet accessibility standards Date: 19. May 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - materials for implants
Reference 03859/16

Urgent field safety notice for Monaco RTP System, IMPAC Medical Systems Inc. / Elekta AB PDF, 123KB, File does not meet accessibility standards Date: 19. May 2016 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 04142/16

Urgent field safety notice for iGUIDE 2.1 / iGUIDE 2.2, Elekta AB / Medical Intelligence Medizintechnik GmbH PDF, 39KB, File does not meet accessibility standards Date: 17. May 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 03989/16

Recall of rope lock Axis, Redcord AS PDF, 130KB, File does not meet accessibility standards Date: 17. May 2016 Topics: Medical devices Type: Customer information

Product group Physical therapy - others
Reference 03868/16

Lot recall of gauze compresses MK sterile 10x10 cm 12-fold / 10 x 10 pieces / Box (Art. No. 25112), MaiMed GmbH PDF, 204KB, File does not meet accessibility standards Date: 17. May 2016 Topics: Medical devices Type: Customer information

Product group Dressings / Pads - dressings
Reference 03916/16

Urgent field safety notice for TIGR Matrix Surgical Mesh, Novus Scientific AB PDF, 196KB, File does not meet accessibility standards Date: 17. May 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 04082/16

Urgent field safety notice for ARGENE products, bioMérieux SA PDF, 410KB, File does not meet accessibility standards Date: 17. May 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 04055/16

Urgent Field Safety Notice for TnI-Ultra - Biotin Interference, Siemens Healthcare Diagnostics Inc. PDF, 64KB, File does not meet accessibility standards Date: 17. May 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 04036/16

Urgent field safety notice for Eva Mobile Lifts, Handicare AB PDF, 595KB, File does not meet accessibility standards Date: 13. May 2016 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - ward equipment and equipment for emergency medical services
Reference 03777/16

Urogynecological use of surgical meshes Date: 13. May 2016 Topics: Medical devices Type: Article

The BfArM would like to draw attention to the recent SCENIHR publication regarding the use of surgical meshes in urogynecological surgery.

Recall of Clinpro Glycine Prophy Powder with TCP, 3M Deutschland GmbH PDF, 103KB, File does not meet accessibility standards Date: 13. May 2016 Topics: Medical devices Type: Customer information

Product group Dental products - instruments
Reference 04034/16

Lot recall of Hygro-c Inserter, privelop-spine AG PDF, 99KB, File does not meet accessibility standards Date: 12. May 2016 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 03472/16

Urgent field safety notice for ADVIA Centaur XPT System (SMN 10711433), Siemens Healthcare Diagnostics Inc. PDF, 25KB, File does not meet accessibility standards Date: 12. May 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 03991/16

Lot recall of TRUEresult Blood Glucose Test Strips (GDH-FAD), Nipro Diagnostics / Nipro Europe PDF, 238KB, File does not meet accessibility standards Date: 12. May 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 03864/16

Urgent Field Safety Notice for AssayTip / AssayCup, Roche PDF, 164KB, File does not meet accessibility standards Date: 12. May 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 03683/16

Urgent field safety notice for rechargeable implantable neurostimulators RestoreSensor / RestoreSensor SureScan MRI (models 37714 and 97714), Medtronic PDF, 84KB, File does not meet accessibility standards Date: 12. May 2016 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - biostimulators
Reference 03832/16

Urgent field safety notice for Sternal Retractor, Genesee BioMedical Inc. / Landmark Surgical PDF, 178KB, File does not meet accessibility standards Date: 12. May 2016 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - general instruments
Reference 02665/16

Urgent field safety notice for Commander Delivery System (Models 9610TF23 / 9610TF26 / 9610TF29), Edwards Lifesciences PDF, 67KB, File does not meet accessibility standards Date: 12. May 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 03982/16

Lot recall for GEM Microvascular Anastomotic Coupler, Synovis Micro Companies Alliance Inc. / Baxter International Inc. PDF, 388KB, File does not meet accessibility standards Date: 12. May 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 03688/16

Urgent field safety notice for ProcedurePak kits and trays with umbilical clamps IFKR21, Mölnlycke Health Care PDF, 87KB, File does not meet accessibility standards Date: 11. May 2016 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - gynaecology
Reference 01850/16

Urgent field safety notice for ProcedurePak with umbilical clamps IFKR08, Mölnlycke Health Care PDF, 136KB, File does not meet accessibility standards Date: 11. May 2016 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - gynaecology
Reference 01011/16

Urgent Field Safety Notice for MobileDiagnost wDR 2, Philips Medical Systems PDF, 27KB, File does not meet accessibility standards Date: 11. May 2016 Topics: Medical devices Type: Customer information

Product group Radiological technology - stationary radiological equipment
Reference 03751/16