BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    ENCORE IGE REAGENT

    FDA 510(k)
    FDA Class 2 ·Immunology

    TACTIX Vector Syndesmosis System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PIEZOSURGERY DEVICE

    FDA 510(k)
    FDA Class 2 ·Dental

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 2, 2014

    QUATTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·November 15, 2012

    MEDTRONIC CARELINK MONITOR

    FDA Adverse Event
    Death ·MEDTRONIC MILACA INC.·Product code DXH·September 24, 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