BEUDAMED
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    ELECTROLYTES (NA+, K+, CL-), PRODUCT NO'S 114-01, 114-02, 114-03

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MaXcess

    FDA UDI
    Nuvasive, Inc.·00887517201294·MaXcess-C Blade, 70mm Lateral Smooth

    VV330 Continuous ECG Platform, VivaLNK Adhesive Patch

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TORNIER, PITON FIXATION IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TITANIUM SCREW LOW PROFILE 5X40MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWT·November 18, 2016

    TITANIUM SCREW LOW PROFILE 5X40MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWT·November 18, 2016

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·March 6, 2013

    CAPSURE EPI

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code DTB·February 15, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 8, 2014

    1.5 LACTOSORB SYSTEM 1.5 X 5 MM LACTOSORB SCREW

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·August 22, 2018

    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