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

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    COLOSCREEN SELF-TEST

    FDA 510(k)
    FDA Class 2 ·Hematology

    IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3 Calibration Verification Material

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    GOCANNING GLS-700 E-PULSE ANALYSIS MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ECHELON*FLEX45 ARTICULATING ENDOSCOPIC LINEAR CUTTER, 45 MM

    FDA Adverse Event
    Death ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 2, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 23, 2012

    ACRYSOF TORIC

    FDA Adverse Event
    Malfunction ·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·September 22, 2010

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024