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

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    BIOMET CONCENTRIC HEX SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·April 30, 2014

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·October 10, 2012

    INRATIO2

    FDA Adverse Event
    Malfunction ·BIOSITE INCORPORATED·Product code GJS·July 30, 2010

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022

    ACCOLADE SR SL MRI (Model L310)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025