BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    TITAN GEL REP CPK-6 HV

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556704315·GC Initial™ Ti Inside IN-44 Sand, 20g

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228741441·GC Initial™ Ti Inside IN-44 Sand, 20g

    UNSCENTED MENSTRUAL PAD

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    SCD STERILE CONNECTION DEVICE

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

    AMBU BAG

    FDA Adverse Event
    Malfunction ·VENTILAB·Product code BTM·June 10, 2014

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·October 15, 2010

    UNKNOWN MEDTRONIC HARDWARE

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWQ·December 14, 2012

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

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