BEUDAMED
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    TITANIUM INTRAMEDULLARY NAILS-VARIOUS STYLES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SYNCHRON CREATINE KINASE REAGENT

    FDA Adverse Event
    BECKMAN COULTER INC.·Product code CGS·June 17, 2011

    ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    HYDRAMED BY LECHLER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ACCURUS 400VS

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·February 26, 2013

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·February 9, 2011

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.,·Product code CBK·July 2, 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