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

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    MONTGOMERY RADIOPAQUE LARYNGEAL KEEL

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    VertebraLINK Fusion Platform

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GLADIATOR BIPOLAR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INRATIO PT/INR TEST STRIPS

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·June 19, 2014

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·February 14, 2013

    TRIDENT ALUMINA INSERT

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS CORK·Product code MEH·January 10, 2011

    Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration

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