BEUDAMED
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    RAPID IDENTI. TEST FOR MYCOBACTERIUM TB COMPLEX

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Infinix, INFX-8000V, V6.35

    FDA 510(k)
    FDA Class 2 ·Radiology

    VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    KAPPA 900 DR

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO, MED REL·Product code DXY·June 10, 2014

    FREESTYLE FREEDOM LITE

    FDA Adverse Event
    Injury ·Product code NBW·October 8, 2010

    UNKNOWN DEPUY SROM HEAD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWA·December 10, 2012

    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