BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    H20- TETHERED OPTION

    FDA 510(k)
    FDA Class 2 ·Neurology

    SKINTACT AND VARIOUS OTHER TRADENAMES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TidalPort-AP Implantable Apheresis Vascular Access Port

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·August 1, 2024

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·March 1, 2013

    RENAL - DISPOSABLE

    FDA Adverse Event
    Injury ·Product code KDJ·February 15, 2011

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MPRI·Product code DTB·August 8, 2014

    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