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

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    ACCU-CHEK Performa Blood Glucose Monitoring System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ERCHONIA PL5000

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SURGISURE TISSUE REMOVAL SYSTEM

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 29, 2025

    AEQUALIS

    FDA Adverse Event
    Injury ·TORNIER SAS·Product code KWS·May 23, 2013

    JOURNEY BCS

    FDA Adverse Event
    Injury ·SMTIH & NEPHEW, INC. ORTHOPAEDIC DIVISION·Product code JWH·June 20, 2011

    FLEXIMA BILIARY STENT

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code FGE·August 20, 2008

    VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX

    FDA Enforcement
    Class II ·Terminated·Civco Medical Instruments Co. Inc.·December 29, 2021