BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

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    H.T.U. (HYPERBARIC THERAPY UNIT)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ANGIOPLASTY INFLATION DEVICE & CARTR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PHARMACIA STREP A DIRECT SWAB TEST

    FDA 510(k)
    FDA Class 1 ·Microbiology

    ACTIVA

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·June 16, 2014

    INTELLIVUE MULTI MEASUREMENT SERVER X2

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·October 15, 2010

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·December 14, 2012

    PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI 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

    PM 1260 ASSURITY + 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