BEUDAMED
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    BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SUN-RAIN ULTRASONIC THERAPY MODELS, SU-300, SU-400, SU-500, SU-600, SU-700, SU-800, SU-900

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Soliton Acoustic Wave Device

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

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·March 5, 2013

    ADAPTA SR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NVZ·February 15, 2011

    INSYNC III PROTECT

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code NIK·August 8, 2014

    Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXR Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by user. The Spectrum and Spectrum with MAster Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·May 16, 2018