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

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    PYMAH COLD STERILOG GLUTARALDEHYDE MONITOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MAXI-FLOW SUCTION SET 12 FT.

    FDA 510(k)
    FDA Class 2 ·General Hospital

    THERAPEUTIC DRUG MONIT CONTROL, SET II, LEVEL II

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SERVO-I

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·May 13, 2014

    PULSE GEN MODEL UNK

    FDA Adverse Event
    Death ·CYBERONICS·Product code LYJ·January 15, 2013

    LIGAMAX-5MM ENDO CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·December 6, 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