BEUDAMED
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    UNSATURATED IRON BINDING CAPACITY

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    KENDRICK EXTRICATION DEVICE

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    Zimmer Biomet Select Ceramic Heads

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NANOKNIFE SYSTEM

    FDA Adverse Event
    Malfunction ·ANGIODYNAMICS·Product code OAB·May 27, 2014

    COOL PATH DUO 7F, 1304-CP2-7-1.5(5)-L1-TE4BE1AB

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, IRVINE·Product code OAD·October 11, 2010

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·November 6, 2012

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017