BEUDAMED
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    NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATION CATHETER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SPRINT FIDELIS

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·February 9, 2013

    VITALITY AVT

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 10, 2011

    5F STIFF MICRO-STICK

    FDA Adverse Event
    Malfunction ·MEDCOMP·Product code DYB·July 3, 2014

    Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI Model Numbers: PM1224, PM2218, PM2224 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