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

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    ARGENCO 46 TYPE III DENTAL GOLD ALLOY

    FDA 510(k)
    FDA Class 2 ·Dental

    EXAPACS

    FDA 510(k)
    FDA Class 2 ·Radiology

    Vagisan MoistCream Cremolum

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 22, 2024

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 25, 2014

    UNKNOWN

    FDA Adverse Event
    Death ·RESMED LTD.·Product code BZD·November 4, 2010

    V40 COCR LFIT HEAD 36MM/+5

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code JDI·December 21, 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