BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    PULMANEX TM (NEO-NATAL SIZE)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TROCHANTER CABLE GRIP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CEB

    FDA 510(k)
    FDA Class 1 ·Microbiology

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·June 19, 2014

    ENGAGE INTRODUCER, TF 6 FR 12 CM 0.038 GW

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL·Product code DYB·October 20, 2010

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·December 21, 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