BEUDAMED
    7 results · 24ms · Sources: EU EUDAMED, US FDA

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    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MODIFICATION TO EEG MONITOR WITH BIS, MODEL A-2000

    FDA 510(k)
    FDA Class 2 ·Neurology

    NMI PORT II CATHETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·COCHLEAR LTD.·Product code MCM·May 27, 2014

    3.0MM TI STERNAL LCKNG SCREW SELF-DRILLING/14MM

    FDA Adverse Event
    Injury ·Product code HWC·November 14, 2012

    LIGAMAX-5MM ENDO CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code FZP·September 12, 2007

    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