BEUDAMED
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    BIO-INTERFERENCE SCREW, 7 MM, 8 MM, 9 MM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ENDOPATH DILATING TIP TROCAR

    FDA Adverse Event
    Malfunction ·EES-JUAREZ·Product code GCJ·February 25, 1997

    Emprint SX Ablation Platform and Accessories

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

    REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LOGIC TIBIA PS MOD INSRT SZ 2.5 11MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·May 28, 2024

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 21, 2013

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Death ·CORDIS LLC (PR)·Product code NIQ·January 27, 2011

    TELIGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 31, 2014

    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