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

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    INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Archon

    FDA UDI
    Nuvasive, Inc.·00887517312013·Archon Screw, 4.5x17mm S.T. Variable

    CONDUCTIVE SHOE COVERS

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

    E-CUBE 8

    FDA 510(k)
    FDA Class 2 ·Radiology

    AED PLUS

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·June 2, 2014

    BLAKE DRAIN

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code KOG·October 20, 2010

    12/14 ARTICUL 40MM M SPEC+5

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·December 20, 2012

    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