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

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    NOVA 5 NA/K/C1 ALALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    STAT(TM) GLOVE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SEAL-RITE SILICONE EAR PLUG

    FDA 510(k)
    FDA Unclassified ·Unknown

    HEARTSTART FR3 ECG, BASIC BUNDLE, JAPAN

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 16, 2014

    ASR UNI FEMORAL IMPL SIZE 53

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·January 15, 2013

    PROWLER SELECT MICROCATHETERS

    FDA Adverse Event
    Injury ·CORDIS NEUROVASCULAR, INC.·Product code KRA·December 6, 2010

    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