BEUDAMED
    8 results · 22ms · Sources: EU EUDAMED, US FDA

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    SURGICAL SKIN MARKER

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    POTASSIUM AND SODIUM ELECTROLYTE ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DEXTROLYTE II CAPD TRANSFER SET - NO. 48-4009-6

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PEDIATRIC SOFTVENT

    FDA Adverse Event
    Injury ·UNOMEDICAL SDN BHD·Product code BTR·February 12, 2018

    HT70 VENTILATOR

    FDA Adverse Event
    Malfunction ·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·May 19, 2014

    MINICAP EXTEND LIFE PD TRANSFER SET - JAPAN

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·November 11, 2010

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCOR·Product code CBK·December 28, 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