BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

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    MAXICAMERA 400 AC

    FDA 510(k)
    FDA Class 1 ·Radiology

    BioBrace® Reinforced Implant

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    EXACTECH 12/14 TOTAL HIP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·May 30, 2014

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·November 21, 2012

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code KWQ·September 17, 2010

    Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophthalmic surgeons in a variety of ophthalmic surgeries.

    FDA Enforcement
    Class II ·Terminated·Alcon Research, LLC·October 21, 2020

    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