BEUDAMED
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    MEDICOMP FLEXI-SMOOTH WOUND DRAINAGE CATHETER

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ReLine

    FDA UDI
    Nuvasive, Inc.·00195377096692·RELINE C Screw, 4.0x26mm Reduction FA

    LIBERTY GLUCOSE NORMAL CONTROL SOLUTIONS, MODEL 2120041

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    syngo.via MI Workflows

    FDA 510(k)
    FDA Class 2 ·Radiology

    OUTLOOK ES

    FDA Adverse Event
    Malfunction ·B. BRAUN MEDICAL, INC.·Product code FRN·December 16, 2010

    BREEZE2

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·February 14, 2013

    LAMITRODE 44

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·July 17, 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