BfArM - Federal Institute for Drugs and Medical Devices

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14,965 results

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Urgent Field Safety Notice for Minstrel by ArjoHuntleigh AB PDF, 355KB, File does not meet accessibility standards Date: 07. January 2019 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - ward equipment and equipment for emergency medical services
Reference 14708/18

Urgent Field Safety Notice for Celsite Safety by B.BRAUN MEDICAL Saint Cloud PDF, 30KB, File does not meet accessibility standards Date: 07. January 2019 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 15372/18

Urgent Field Safety Notice for Eye Station by Merge Healthcare PDF, 55KB, File does not meet accessibility standards Date: 07. January 2019 Topics: Medical devices Type: Customer information

Product group Radiological technology - auxiliary equipment and supplies for radiology / nuclear medicine
Reference 15972/18

Urgent Field Safety Notice for Mayfield Skull Clamp by IntegraLifeSciences Mayfield PDF, 2MB, File does not meet accessibility standards Date: 07. January 2019 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 15706/18

Urgent Field Safety Notice for Baha 5 Sound Processor Tamper-proof battery door 3 by Cochlear Bone Anchored Salutions AB PDF, 412KB, File does not meet accessibility standards Date: 07. January 2019 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - ENT equipment
Reference 15985/18

Urgent Field Safety Notice for Flexima Duodenal Bend Biliary Stent with Delivery by Boston Scientific Corporation Marlborough PDF, 171KB, File does not meet accessibility standards Date: 07. January 2019 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - drainages and suction systems
Reference 16344/18

Increased occurrence of corneal haze after implantation of the Raindrop Near Vision Inlay (FDA Safety Communication) Date: 07. January 2019 Topics: Medical devices Type: Article

According to new clinical study results, the Raindrop implant (Brand name: Raindrop Near Vision Inlay; manufacturer: ReVision Optics) may lead to an increased occurrence of corneal haze.
The BfArM would like to refer to a recent FDA Safety …

Urgent Field Safety Notice for Brustimplantat / verschiedene Modelle, Allergan Limited PDF, 507KB, File does not meet accessibility standards Date: 21. December 2018 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 15914/18

Urgent Field Safety Notice by OHST Medizintechnik AG: Handling of fractured ceramic inserts and ceramic head fractures PDF, 469KB, File does not meet accessibility standards Date: 20. December 2018 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 00733/18

Urgent Field Safety Notice for StealthAir Percutaneous Pin Adapter by Medtronic Navigation Inc. PDF, 109KB, File does not meet accessibility standards Date: 20. December 2018 Topics: Medical devices Type: Customer information

Product group Radiological technology - navigation systems
Reference 15812/18

Urgent Field Safety Notice for Push Valve / Mag Valve by Ottobock S. & Co. KGaA PDF, 145KB, File does not meet accessibility standards Date: 20. December 2018 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology - orthoses
Reference 15846/18

Urgent Field Safety Notice for IVUS Katheter by Philips Volcano PDF, 1MB, File does not meet accessibility standards Date: 20. December 2018 Topics: Medical devices Type: Customer information

Product group Ultrasonics - ultrasonic diagnostic equipment
Reference 14205/18

Urgent Field Safety Notice for MAVIG Portegra/Portegra2 Overhead Counterpoise System by Bayer Medical Care Inc. PDF, 328KB, File does not meet accessibility standards Date: 20. December 2018 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 15801/18

Urgent Field Safety Notice for SurdialTM X by Nipro Corporation PDF, 1MB, File does not meet accessibility standards Date: 20. December 2018 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - dialysis technology
Reference 15489/18

Urgent Field Safety Notice for SiroLaser Blue by Sirona Dental Systems GmbH PDF, 169KB, File does not meet accessibility standards Date: 19. December 2018 Topics: Medical devices Type: Customer information

Product group Dental products - equipment
Reference 15382/18

Urgent Field Safety Notice for Stryker model Nära Hospital Bassinet by Stryker Medical-Kalamazoo PDF, 238KB, File does not meet accessibility standards Date: 19. December 2018 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - furnishings
Reference 13250/18

Urgent Field Safety Notice for BIOLOX delta Pfanneneinsatz Größe Ø 36/44 mm by implantcast GmbH PDF, 396KB, File does not meet accessibility standards Date: 19. December 2018 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 15639/18

Urgent Field Safety Notice for Tritanium PL Spinal Cage by Stryker Spine-US PDF, 183KB, File does not meet accessibility standards Date: 19. December 2018 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 15734/18

Urgent Field Safety Notice for Visum LED by Stryker Communications PDF, 442KB, File does not meet accessibility standards Date: 19. December 2018 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 14781/18

Urgent Field Safety Notice for Xsense DR by General Medical Merate S.p.A. PDF, 659KB, File does not meet accessibility standards Date: 18. December 2018 Topics: Medical devices Type: Customer information

Product group Radiological technology - stationary radiological equipment
Reference 14720/18

Urgent Field Safety Notice for MOSAIQ and Sequencer by Elekta Inc., Sunnyvale PDF, 70KB, File does not meet accessibility standards Date: 18. December 2018 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 15495/18

Urgent Field Safety Notice for PLATINIUM by MicroPort CRM S.r.l. PDF, 1,021KB, File does not meet accessibility standards Date: 18. December 2018 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - defibrillators
Reference 08598/18

Urgent Field Safety Notice for CARDIOVIT MS-2010 by Schiller AG PDF, 6MB, File does not meet accessibility standards Date: 18. December 2018 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 15197/18

Urgent Field Safety Notice for CELLEX Photopheresis System by Therakos Inc. (Bedminster) PDF, 112KB, File does not meet accessibility standards Date: 18. December 2018 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - therapeutic apheresis procedures
Reference 11292/18

Urgent Field Safety Notice for I-View Contrast Enhanced Digital Mammography by Hologic, Inc. (Danbury) PDF, 724KB, File does not meet accessibility standards Date: 17. December 2018 Topics: Medical devices Type: Customer information

Product group Radiological technology - radiological equipment for mammographic diagnostics
Reference 15431/18

Urgent Field Safety Notice for Discovery NM 530c, Ventri by GE Medical Systems Israel, Functional Imaging PDF, 605KB, File does not meet accessibility standards Date: 13. December 2018 Topics: Medical devices Type: Customer information

Product group Radiological technology - equipment for nuclear medical functional and localisation diagnostics
Reference 15490/18

Urgent Field Safety Notice for CombiDiagnost by Philips Medical Systems DMC GmbH PDF, 2MB, File does not meet accessibility standards Date: 11. December 2018 Topics: Medical devices Type: Customer information

Product group Radiological technology - stationary radiological equipment
Reference 15209/18

Urgent Field Safety Notice for VisuMax by Carl Zeiss Meditec AG PDF, 114KB, File does not meet accessibility standards Date: 11. December 2018 Topics: Medical devices Type: Customer information

Product group ophthalmological technology - equipment for ophthalmological therapeutics
Reference 14954/18

Urgent Field Safety Notice for Diverse Endoscope by Olympus Medical Systems Corp. PDF, 351KB, File does not meet accessibility standards Date: 11. December 2018 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - endoscopes
Reference 14247/18