BfArM - Federal Institute for Drugs and Medical Devices

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14,993 results

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Urgent Field Safety Notice for SCFE DRIVER KNOB SUBASSY by Pega Medical, Inc. PDF, 505KB, File does not meet accessibility standards Date: 10. October 2019 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 13574/19

Urgent Field Safety Notice for NUBIC by Signus Medizintechnik GmbH PDF, 2MB, File does not meet accessibility standards Date: 10. October 2019 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 13563/19

Urgent Field Safety Notice for Agilon Schraube M5 by implantcast GmbH PDF, 170KB, File does not meet accessibility standards Date: 10. October 2019 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 13533/19

Urgent Field Safety Notice for BardPort, X-Port and Groshong by Bard Access Systems Division (BASD) PDF, 210KB, File does not meet accessibility standards Date: 09. October 2019 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 13451/19

Critical vulnerabilities in operating systems of different manufacturers Date: 09. October 2019 Topics: Medical devices Type: Article

BfArM refers to a publication about potential cybersecurity vulnerabilities in operating systems of different manufacturers issued by FDA.

Urgent Field Safety Notice for S.-3t & S.-3t Transesophageal (TEE) Transducers by Philips Medical Systems - Ultrasound PDF, 85KB, File does not meet accessibility standards Date: 08. October 2019 Topics: Medical devices Type: Customer information

Product group Ultrasonics - ultrasonic diagnostic equipment
Reference 13348/19

Urgent Field Safety Notice for HandyVac, Guedel Airways, Universal Connector, Exchange bags for UnoMeter 500 by ConvaTec Limited Deeside PDF, 776KB, File does not meet accessibility standards Date: 08. October 2019 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - drainages and suction systems
Reference 13251/19

Urgent Field Safety Notice for Measuring impactor by Mathys AG Bettlach PDF, 135KB, File does not meet accessibility standards Date: 07. October 2019 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 13252/19

Urgent Field Safety Notice for ECHELON FLEX ENDOPATH 60mm Staplers by Ethicon Endo-Surgery, LLC. PDF, 301KB, File does not meet accessibility standards Date: 07. October 2019 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - general instruments
Reference 13289/19

Urgent Field Safety Notice for VNS Therapy SenTiva Generator by LivaNova, Inc PDF, 94KB, File does not meet accessibility standards Date: 07. October 2019 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - biostimulators
Reference 12829/19