BEUDAMED
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    WIDEX HEARING AID MODEL ES1

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    Patterson

    FDA UDI
    PATTERSON DENTAL SUPPLY, INC.·D6620708723741·FILE, PULP CANAL, ENDODONTIC

    ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    COMPASS

    FDA 510(k)
    FDA Class 2 ·Radiology

    M2A-MAGNUM MOD HD SZ 48MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·June 13, 2014

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LGW·October 11, 2010

    ENCORE BALLOON CATHETER INFLATION DEVICE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - CORK·Product code MAV·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