BEUDAMED
    7 results · 25ms · Sources: EU EUDAMED, US FDA

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    THERMOWRAP, A/K/A/, THERMAL WRAP

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    JET VENTILATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LIQUID-STAT REAGENT FOR ASSAY OF CHOLES.

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PRECISION SPECTRA®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 13, 2014

    SOLN SET,100IN,10DPM,LLPUMP COMPATIBLE, 48EA/CA

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SHERBROOKE·Product code FPA·October 18, 2010

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 13, 2012

    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