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

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    CLIRANS BLOOD LINES SET

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

    UNIPAK CHOLESTEROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    X-RAY DEVICE, MAMMOGRAPHIC DIAGNOSTIC

    FDA 510(k)
    FDA Class 2 ·Radiology

    U BY KOTEX SLEEK

    FDA Adverse Event
    Malfunction ·KIMBERLY-CLARK CORPORATION - CONWAY MILL·Product code HEB·April 24, 2014

    COROENT XL PEEK

    FDA Adverse Event
    Malfunction ·NUVASIVE·Product code KWQ·September 28, 2012

    ENDOSTAT ELECTROSURGICAL UNIT

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code KNS·July 27, 2010

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

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