BEUDAMED
    7 results · 17ms · Sources: EU EUDAMED, US FDA

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    IVAC(R) SITE-SAVER(R) VOLUMETRIC CONTROLLER - 280+

    FDA 510(k)
    FDA Class 2 ·General Hospital

    UVA SUNTANNING LAMPS

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

    MEDIPART FILTER & TUBING MP-02X

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FPA·June 16, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code NBW·October 19, 2010

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 29, 2015

    Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAX 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