BEUDAMED
    7 results · 20ms · Sources: EU EUDAMED, US FDA

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    SECURE-SITE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    NeuroQuant

    FDA 510(k)
    FDA Class 2 ·Radiology

    COOL TEMP NATURAL

    FDA 510(k)
    FDA Class 2 ·Dental

    ACROBAT-I STABILIZER

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code MWS·January 31, 2013

    ENDOPATH ETS FLEX45

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code GDW·December 8, 2010

    PONTO IMPLANT WITH ABUTMENT

    FDA Adverse Event
    Other ·OTICON MEDICAL AB·Product code MAH·July 7, 2014

    PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF 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