BEUDAMED
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    5.0MM SPLINE ENDOSSEOUS DENTAL IMPLANT SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Dental

    CREATININE (RATE) REAGENT SET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    IONOFIL/LONOFIL MOLAR

    FDA 510(k)
    FDA Class 2 ·Dental

    ENDEAVOR SPRINT RX

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code NIQ·February 11, 2013

    TENDRIL SDX

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

    ACCU-CHEK ® AVIVA COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code NBW·July 24, 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