BfArM - Federal Institute for Drugs and Medical Devices

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14,982 results

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Urgent Field Safety Notice for BEO NC by SIS Medical AG PDF, 809KB, File does not meet accessibility standards Date: 12. November 2020 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 19150/20

Urgent Field Safety Notice for Mölnlycke Procedure Trays by Mölnlycke Health Care AB PDF, 4MB, File does not meet accessibility standards Date: 12. November 2020 Topics: Medical devices Type: Customer information

Product group Dressings / Pads - others
Reference 17527/20

Damage of hip stem prostheses (neck area) caused by high-frequency cauterizing instruments (e. g. cautery knife) Date: 11. November 2020 Topics: Medical devices Type: Article

BfArM has received several incident reports about fractures in the neck area of the stem hip implant made of titan alloy.

Urgent Field Safety Notice for Scope Procedure Kit & RGX Taper Cap by Biomet Orthopedics, LLC PDF, 594KB, File does not meet accessibility standards Date: 11. November 2020 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 17167/20

Urgent Field Safety Notice for Scope Procedure Kit & RGX Taper Cap by Biomet Orthopedics, LLC PDF, 396KB, File does not meet accessibility standards Date: 11. November 2020 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 17167A/20

Urgent Field Safety Notice for V60 / V60 Plus by Respironics California, Inc. PDF, 82KB, File does not meet accessibility standards Date: 10. November 2020 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 17538/20

Urgent Field Safety Notice for 980 Ventilator, Compressor Configuration, Germany (PB 980) by Covidien llc PDF, 62KB, File does not meet accessibility standards Date: 10. November 2020 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 18099/20

Urgent Field Safety Notice for Alaris GP and GP Guardrails, Alaris NEXUS GP by BD Switzerland Sarl PDF, 59KB, File does not meet accessibility standards Date: 10. November 2020 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 19067/20

Urgent Field Safety Notice for Dura retractor & Nerve roots retractor by SpineVersion S.A.S. PDF, 286KB, File does not meet accessibility standards Date: 10. November 2020 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - neurosurgery
Reference 18880/20

Urgent Field Safety Notice for AMS 700 CX MS P Auffüllbares Schwellkörperimplantat by AMS - American Medical Systems, Inc. PDF, 723KB, File does not meet accessibility standards Date: 10. November 2020 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 15867/20