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

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    OSTEO AUSTIN MOORE ENDOPROSTHESIS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    APEX HELIX - A

    FDA 510(k)
    FDA Class 2 ·Radiology

    EXTRAVAKIT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SOFTHEAT

    FDA Adverse Event
    Other ·KAZ, INC.·Product code IRT·February 13, 2013

    PRECISION TEST STRIPS

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 31, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·August 4, 2014

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

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