BEUDAMED
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    Saxxony™ Posterior Cervical Thoracic System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PROPELLER HEAD SCREW SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304270169·

    3DP Lumbar Interbody System

    FDA UDI
    Genesys Orthopedics Systems LLC·M719GL3DS1825080·Small 8-Degree LLIF - 18mm x 25mm

    3DP Lumbar Interbody System

    FDA UDI
    Genesys Orthopedics Systems LLC·M719GL3DM1825080·Medium 8-Degree 3DP LLIF - 18mm x 25mm

    FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCREEN DIPCARD

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    YU LONG SHENG DISPOSABLE THERMOMETER SHEATHS, MODELS YLS-01 AND YLS-02

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ENDURANT II

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code MIH·October 17, 2014

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·June 11, 2013

    HUDSON INCENTIVE SPIROMETER LUNG VOLUME EXERC.

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code BWF·July 8, 2011

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014