BEUDAMED
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    BRODA NURSING CARE CHAIR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    ULTRASOUND SCANNER MODEL #1150

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFIED PGL ABSORBABLE STAPLE*

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    VASOVIEW HEMOPRO 2

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC.·Product code GEI·January 3, 2013

    SERIES 50 XM FETAL/MATERNAL MONITOR

    FDA Adverse Event
    Death ·PHILIPS MEDICAL SYSTEMS·Product code HGM·November 16, 2010

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 1, 2014

    TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z

    FDA Enforcement
    Class II ·Ongoing·Acclarent, Inc.·December 29, 2021

    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