BEUDAMED
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    SAS SHIGELLA BOYDII GROUP C2 ANTISERUM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    KORLEX-GR GINGIVAL RETRACTION PASTE

    FDA 510(k)
    FDA Unclassified ·Unknown

    MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CAPSURE VDD

    FDA Adverse Event
    Injury ·MEDTRONIC, B.V.·Product code DXY·February 9, 2013

    CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·January 7, 2011

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 23, 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