BfArM - Federal Institute for Drugs and Medical Devices

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14,998 results

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Urgent Field Safety Notice for IONTRIS by Siemens Healthcare GmbH, Advanced Therapies, Particle Therapy PDF, 87KB, File does not meet accessibility standards Date: 07. January 2019 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - nuclear medical therapeutic equipment
Reference 15903/18

Urgent Field Safety Notice for Mobi-C by LDR MEDICAL PDF, 445KB, File does not meet accessibility standards Date: 07. January 2019 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 16356/18

Urgent Field Safety Notice for CW002, 5x42CM EPIX ES PRB SMK EVAC LHOOK by Applied Medical Resources Corporation PDF, 519KB, File does not meet accessibility standards Date: 07. January 2019 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - endoscopes
Reference 16235/18

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 …