BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    PRESSURE RELIEF SEAT CUSHION

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    ARIA II 125 I CORTISOL

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SILICONE BLOCK

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    PENUMA IMPLANT

    FDA Adverse Event
    Injury ·NATIONAL MEDICAL DEVICES INC.·Product code MIB·March 1, 2018

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·June 1, 2014

    TOTALCARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·November 9, 2012

    SINGLE 8 EXTENSION

    FDA Adverse Event
    Malfunction ·ADVANCED NEUROMODULATION SYSTEMS, INC.·Product code LGW·August 31, 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