BEUDAMED
    7 results · 17ms · Sources: EU EUDAMED, US FDA

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    GAMMA STERIL. CAPILLARY FLOW DIALY-G15

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

    QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CRP HIGH SENSITIVITY CONTROLS VE CONTROLS 1/2

    FDA 510(k)
    FDA Class 2 ·Immunology

    I-QARE DS-W BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    OPTIBOND XTR

    FDA Adverse Event
    Injury ·KERR CORPORATION·Product code KLE·May 27, 2014

    ANEURX STENT GRAFT SYSTEM

    FDA Adverse Event
    Death ·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·November 14, 2012

    SOFTCLIX® PLUS LANCET DEVICE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·September 13, 2010

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

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