BEUDAMED
    7 results · 21ms · Sources: EU EUDAMED, US FDA

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    TRI*STAR

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

    INFINITY CENTRALSTATION WITH INFINITY M300

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Pain Therapy Device(Model: P.T.S-X)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·January 28, 2013

    STRATA NSC VALVE, REGULAR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROSURGERY·Product code JXG·December 14, 2010

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·July 12, 2014

    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