BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    VENTRESCREEN II POLLENS ENZYME IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    HEMOCATH II

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

    Penumbra 3D Revascularization Device

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ATTAIN ABILITY

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·October 9, 2010

    7700

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·February 20, 2014

    ASR ACETABULAR IMPLANT 50

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·December 10, 2012

    TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125°

    FDA Adverse Event
    Death ·STRYKER TRAUMA KIEL·Product code HSB·September 29, 2015

    Pipeline Flex Embolization Device

    FDA Enforcement
    Class I ·Ongoing·Micro Therapeutics Inc,·September 15, 2021

    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