BEUDAMED
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    IL 301 PORTABLE TRANSCUT. OXYGEN MONI

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    NA

    FDA UDI
    Richard Wolf GmbH·04055207043325·RECTOSCOPE-OBTURATOR Ø 14.5MM TL 377MM TL 377m...

    LACRYTEST

    FDA 510(k)
    FDA Class 2 ·Immunology

    NIRVANA

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

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·May 27, 2014

    TI 12-POINT NUT-11MM

    FDA Adverse Event
    Injury ·SYNTHES BRANDYWINE·Product code NKB·November 15, 2012

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code MDS·September 14, 2010

    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