BEUDAMED
    7 results · 20ms · Sources: EU EUDAMED, US FDA

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    OLYMPUS PK-TP SYSTEM REACTIVE CONTROL

    FDA 510(k)
    FDA Class 2 ·Microbiology

    EXCEL TECH MST-7 ISOELECTRONIC THERAPY DEVICE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    THOMPSON HIP PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HIRES 90K IMPLANT

    FDA Adverse Event
    Malfunction ·ADVANCED BIONICS LLC·Product code MCM·May 21, 2014

    SKYTRON

    FDA Adverse Event
    Malfunction ·MIZUHO MEDICAL CO LTD·Product code GDC·December 10, 2008

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER CORP, MEDICAL DIV·Product code FNL·November 5, 2010

    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