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

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    LONG HANDLED SPONGE

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    DVTCARE CA5

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OptiCross X, 40 MHz Coronary Imaging Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COAGUCHEK S SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JPA·July 13, 2007

    IVT DISPOSABLE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code KPE·September 26, 2012

    HEARTSTART MRX-EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·December 31, 2013

    DuraLife Autoclavable Silicone Extension Tube, REF 60-1502 (UltraSet Product Code 66-2509); Non-Ported Double Swivel Elbow for use with breathing circuits

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·May 24, 2023