BEUDAMED
    10 results · 34ms · Sources: EU EUDAMED, US FDA

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    SHS CUSHION/WHEELCHAIR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    MYLAB15/20 NEW INDICATIONS ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    Integrity-SI TM Fusion System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    REVEAL XT

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code DSI·June 10, 2014

    ENRHYTHM DR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code DXY·October 8, 2010

    ALUMINUM HOHMANN RETRACTOR 8MM SHORT NARROW TIP

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code KWP·December 7, 2012

    PINNACLE MTL INS NEUT36IDX54OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·June 24, 2014

    ARTICULEZE M HEAD 36MM +12

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·June 24, 2014

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; 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