BEUDAMED
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    ProMIS Extension Rod System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STAXX IBL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GM3 SERIES IF TENS, MODEL GM3X2IF (WHERE X IS A PARAMETER OF DIFFERENT HOUSING)

    FDA 510(k)
    FDA Class 2 ·Neurology

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·November 14, 2008

    DEPUY ASR XL FEM IMP SIZE 51

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 18, 2011

    METRX

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code LXH·July 18, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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