BEUDAMED
    8 results · 25ms · Sources: EU EUDAMED, US FDA

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    AVL MODEL 986 ELECTROLYTE ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Archon

    FDA UDI
    Nuvasive, Inc.·00887517073303·Archon ACP Plate, 40mm, 2-Level

    Empower RF Catheter

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

    OPUS MAGNUM2 AND OPUS MAGNUM X KNOTLESS FIXATION DEVICES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ELECSYS 2010 RACK

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code MMI·October 26, 2010

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·February 7, 2014

    ENDOTRACHEAL TUBE 8229307 NIM EMG 7MM RE

    FDA Adverse Event
    Injury ·MEDTRONIC INC.·Product code ETN·December 21, 2012

    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