BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TEST

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST

    FDA 510(k)
    FDA Class 2 ·Hematology

    IntraClude Intra-Aortic Occlusion Device

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ENDO STITCH 10MM SUTURING DEVICE

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code KOG·May 2, 2014

    ASR ACETABULAR CUPS 52

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·February 15, 2013

    HEARTMATE II SYSTEM CONTROLLER

    FDA Adverse Event
    Malfunction ·THORATEC CORPORATION·Product code DSQ·December 21, 2010

    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

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