BEUDAMED
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    RELSIA SS-A/RO & SS/B LA ANTIBODY TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    CD 3700 SL

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKZ·May 23, 2007

    PHILIPS GYROVIEW-HR IMAGING WORKSTATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    VIROTHERM HUMIDIFIER

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLYNELLCOR PURITAN BENNETT IRELAND·Product code CBK·June 11, 2014

    ADAPTA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·February 11, 2013

    TENDRIL SDX

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·January 10, 2011

    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