BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    MODULAR FIBERSCOPE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    APEX-DL Spine System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Deka Bluebeam

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·February 12, 2014

    CAREASSIST BED

    FDA Adverse Event
    Malfunction ·HILL-ROM PLUVIGNER·Product code FNL·October 25, 2012

    5MM HEADLESS COMPRESSION SCREW

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HWC·September 21, 2010

    BD SAFE-CLIP¿ NEEDLE CLIPPING & STORAGE DEVICE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMI·September 25, 2019

    SHARPS DISPOSAL

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMI·August 16, 2019

    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), product code 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 include pharmaceutical drugs, blood, blood products and mixture of required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluid space. Spectrum Infusion Pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by the user. The Spectrum and Spectrum with Master Drug Library is suitable for many user facility applications such as but not limited to hospitals, outpatient care areas, homecare and ambulatory care services. 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. Parameter programming requires trained healthcare professional confirmation of limits and drug therapy to the physician s directive.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·May 8, 2019