BEUDAMED
    7 results · 20ms · Sources: EU EUDAMED, US FDA

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    IGA

    FDA 510(k)
    FDA Class 2 ·Immunology

    MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DIAGNOSTIC ULTRASOUND SYSTEM SSA-270A

    FDA 510(k)
    FDA Class 2 ·Radiology

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·February 28, 2013

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·February 4, 2011

    INFINITI VISION SYSTEM

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CTR·Product code HQC·July 7, 2014

    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