BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    HPROLACTIN KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges

    FDA 510(k)
    FDA Unclassified ·Unknown

    DIGITAL STEREOLOC II

    FDA 510(k)
    FDA Class 2 ·Radiology

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 13, 2014

    EASYTRAK 2

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code OJX·October 15, 2010

    ACRYSOF RESTOR

    FDA Adverse Event
    Injury ·ALCON RESEARCH. LTD./ HUNTINGTON·Product code HQL·December 6, 2012

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021