BEUDAMED
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    GOULD-STATHAM SP1405 PRESSURE MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INTEL HEALTH GUIDE, MODEL: PHS6000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Prime Acetabular Cup System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 30, 2014

    ASR ACETABULAR IMPLANT 64

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·October 10, 2012

    530G INSULIN PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·May 19, 2015

    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