BEUDAMED
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    MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT

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

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00613994486011·TRAY 9871218 PYRAMID +4 IMPLANT

    PROXENON 350, MODEL 902XX

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

    INTRA-ARTICULAR SHAVER

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    BIVONA TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE

    FDA Adverse Event
    Injury ·SMITHS MEDICAL ASD, INC.·Product code JOH·October 11, 2010

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 12, 2012

    TRILOGY 202

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·April 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