BEUDAMED
    7 results · 16ms · Sources: EU EUDAMED, US FDA

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    SORIN MONOLYRH INTEGRATED MEMBRANE LUNG

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EVENFLO COMFORT SELECT AUTO-CYCLE BREAST PUMP KIT

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

    MYAH

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·January 18, 2013

    SIGMA 300 DR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code DXY·December 13, 2010

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 9, 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