BEUDAMED
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    OPMI MD SURGICAL MICROSCOPE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    CALCIUM REAGENT FOR DEMAND ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ANA APPLELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    GEMSTAR 7 SP NEW

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·April 18, 2014

    BIOHORIZONS DRILL EXTENDER

    FDA Adverse Event
    Other ·BIOHORIZONS IMPLANT SYSTEMS, INC.·Product code DZA·October 8, 2010

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE SUZHOU·Product code CAW·December 14, 2012

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    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