BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    PROM NAID

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    DUAL LUMEN CATHETER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Arrow Epidural Catheter Kit

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BIVONA CUSTOM FLEXTEND TTS TRACH TUBE

    FDA Adverse Event
    Injury ·SMITHS MEDICAL MD, INC.·Product code JOH·May 21, 2014

    TOTALCARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·October 24, 2012

    INFUSION PUMP

    FDA Adverse Event
    Death ·MEDTRONIC MINIMED·Product code LZG·September 20, 2010

    Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24.

    FDA Enforcement
    Class II ·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025

    SIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·August 14, 2024

    1.5T SIGNA HDxt Family, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·August 14, 2024