BEUDAMED
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    QUANTUM BI-POLAR ELECTROSURGICAL CABLE

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

    ATTAIN SELECT 6238TEL GUIDE CATHETER SET FOR LEFT-HEART DELIVERY

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CytoSure Urinary Access System

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

    COMBI SIX STRAP SLING

    FDA Adverse Event
    Malfunction ·TOLLOS, INC.·Product code FNG·January 30, 2013

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC·Product code GJS·December 21, 2010

    PULSE GEN MODEL 101

    FDA Adverse Event
    Death ·CYBERONICS INC·Product code LYJ·July 17, 2014

    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