BEUDAMED
    7 results · 26ms · Sources: EU EUDAMED, US FDA

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    IAS ANESTHESIA MASK

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    ANTIMICROBIAL SUSCEPT. TEST PANEL NITROFURANTOIN

    FDA 510(k)
    FDA Class 2 ·Microbiology

    TERUMO(R) ARTERIAL AND VENOUS BLOOD LINE SET

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES·Product code LZG·June 4, 2014

    UNKNOWN LEFT HIP NECK

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS CORK·Product code MEH·January 10, 2013

    CVC SET: 3-LUMEN 7FR X 2 0CM

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC·Product code DQY·November 5, 2010

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