BEUDAMED
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    Insulin Syringe

    FDA 510(k)
    FDA Class 2 ·General Hospital

    4.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 STRANDS OF #2 PERMACORD SUTURE, 5.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ULTICARE DISPOSABLE SYRINGE 3 ML/CC

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·September 3, 2011

    PULSE GEN MODEL 102

    FDA Adverse Event
    Death ·CYBERONICS INC·Product code LYJ·July 18, 2013

    MX40 1.4 GHZ SMART HOPPING

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code DSI·November 18, 2015

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025