BEUDAMED
    7 results · 27ms · Sources: EU EUDAMED, US FDA

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    AD-TECH'S DEPTH ELECTRODE

    FDA 510(k)
    FDA Class 2 ·Neurology

    EUROSUN MODELS - ES-2400, ES-VHO AND ES-16

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

    PHOENIX-C ANESTHESIA MACHINE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCOR·Product code CBK·May 30, 2014

    CARELINK

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA INC.·Product code NVZ·February 15, 2013

    PRECISION TEST STRIPS

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 20, 2011

    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