BEUDAMED
    7 results · 27ms · Sources: EU EUDAMED, US FDA

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    BIOTROL HDL CHOLESTEROL PRECIPITATION REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    URETHRAL CATHETER TRAY (LATEX)

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

    LINGUAL SHEATH

    FDA 510(k)
    FDA Class 1 ·Dental

    PINNACLE MTL INS NEUT40IDX60OD

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code KWA·January 9, 2013

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·November 15, 2010

    ENDOTAK ENDURANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code LWS·July 1, 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