BEUDAMED
    8 results · 36ms · Sources: EU EUDAMED, US FDA

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    KSEA THERMOCOAGULATOR (MODEL 265100 20)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    RAPITEX(R) RF NEW

    FDA 510(k)
    FDA Class 2 ·Immunology

    ACCESSA CHOLESTEROL PANEL

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GYNECARE X-TRACT MORCELLATOR

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code HET·June 16, 2006

    SPRINTER RX BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·MEDTRONIC CARDIOVASCULAR GALWAY·Product code LOX·December 22, 2010

    PROFEMUR(R) MODULAR FEMORAL NECK SHORT

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LWJ·February 15, 2013

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code ITJ·July 29, 2014

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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