BEUDAMED
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    PRECISION SCREW DRIVER SET

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    MODIFICATION TO HYPERQ SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ePTFE-Coated Auricular Implant

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SPECTRANETICS GLIDELIGHT LASER SHEATH

    FDA Adverse Event
    Injury ·SPECTRANETICS CORPORATION·Product code MFA·June 13, 2014

    ARDIS PEEK IMPLANT 08X09X22

    FDA Adverse Event
    Malfunction ·ZIMMER SPINE·Product code MAX·October 11, 2010

    WANDA¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code LIT·December 13, 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