BEUDAMED
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    MEDI-DYNE APNEA MONITOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    HARBOR Occlusion Device

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CONSENSUS ACETABULAR SHELL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UNKNOWN EXTERNAL NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LGW·September 26, 2012

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 8, 2015

    PULSE GEN MODEL 102

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·July 14, 2010

    Model Number U228, VISIONIST CRT-P EL MRI

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