BEUDAMED
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    BOND FAST NO MIX ADHESIVE

    FDA 510(k)
    FDA Class 2 ·Dental

    PDS POLYDIOXANONE MESH

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    LITHOTRIPTOR ELECTRODE 4.5F

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

    DUNLAP

    FDA Adverse Event
    Other ·KAZ, INC.·Product code IRT·October 12, 2010

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·December 14, 2012

    DEXTRUS 4136

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code NVN·June 16, 2014

    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