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

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    AUTOSTAT II ANTI-TPO

    FDA 510(k)
    FDA Class 2 ·Immunology

    PeriCoach

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

    ALLIGATOR RETRIEVAL DEVICE (ARD)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PERFECT CUT BULLET-TIP ROTATING AORTIC PUNCH

    FDA Adverse Event
    Malfunction ·QUEST MEDICAL, INC.·Product code DWS·December 17, 2010

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·February 5, 2013

    PULSE GEN MODEL 103

    FDA Adverse Event
    Death ·CYBERONICS INC·Product code LYJ·July 18, 2014

    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