BEUDAMED
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    SPECTACLE FRAMES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    DUAL SWITCH

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

    CONTACT HEAT-EVOKED POTENTIAL STIMULATOR (CHEPS)

    FDA 510(k)
    FDA Class 2 ·Neurology

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·May 30, 2014

    ANTIMICROBIAL PICC KIT 1 -LUMEN: 4.5 FR X

    FDA Adverse Event
    Injury ·ARROW INTL., INC.·Product code LJS·November 14, 2012

    CAPSURE EPI

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code DTB·September 23, 2010

    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