BEUDAMED
    8 results · 27ms · Sources: EU EUDAMED, US FDA

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    eCARTv5 Clinical Deterioration Suite (“eCART”)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    S21 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR

    FDA 510(k)
    FDA Class 2 ·Neurology

    NuVasive ACP System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 22, 2025

    EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code KRH·November 12, 2008

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·September 2, 2011

    TOSOH AIA-2000

    FDA Adverse Event
    Injury ·TOSOH HI-TEC, INC.·Product code MRG·July 12, 2013

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·February 24, 2020