BEUDAMED
    9 results · 17ms · Sources: EU EUDAMED, US FDA

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    COTTON FILLED GAUZE SPONGES 2 X 2

    FDA 510(k)
    FDA Class 1 ·Dental

    Eyenez Ophthalmic Camera

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    GORE PRECLUDE VESSEL GUARD

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACUMATCH GXL 15DEG LINER 28MM SZ G

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·November 23, 2022

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 13, 2014

    ADAPTA DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NVZ·October 8, 2010

    INFUSOMAT SPACE

    FDA Adverse Event
    Malfunction ·B. BRAUN MELSUNGEN AG·Product code FRN·December 4, 2012

    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

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012