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

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    INSITUCAT VALVE STRIPPER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PiCCO catheter

    FDA UDI
    Maquet Critical Care AB·27325710017061·

    TDX IMMUNOGLOBULIN A DIAGNOSTIC KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    PUL,MONARY ARTERY VENT CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NOGA-STAR¿ CARDIOLOGY CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code DRF·June 19, 2014

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·October 20, 2010

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL NEUROMODULATION·Product code LGW·December 18, 2012

    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