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

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    LASERSHARE PRINT SPOOLER AND/OR SOFTWARE

    FDA 510(k)
    FDA Class 1 ·Radiology

    GS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    TANDEM-M IMMUNOENZYMETRIC ASSAY FOR HUM/CHOR/GONA

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PROFEMUR(R) MODULAR FEMORAL NECK

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LWJ·February 15, 2013

    BIPOL LEAD MODEL UNKNOWN

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·December 22, 2010

    SYSTEM CONSOLE

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·December 13, 2013

    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