BEUDAMED
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    THE GRONINGEN VOICE PROSTHESIS

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

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209124763·

    M.U.S.T. Pedicle Screw System - Extension

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TORQUE PLUS CATALOG 30120

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

    TRILOGY 202

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·April 16, 2014

    VENTAK PRIZM

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 5, 2010

    OT VERIO IQ METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 3, 2012

    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