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

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    CURITY I.V. START KIT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    StarGuide

    FDA UDI
    G E MEDICAL SYSTEMS ISRAEL LTD.·00195278755544·StarGuide NM GANTRY MDR FINAL

    ABL800 FLEX with AQURE connectivity

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PANTHERA N POWDER FREE BLACK NITRILE GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    NEURON DELIVERY CATHETER 053

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code DQY·November 21, 2012

    RESTORELLE Y SHAPE

    FDA Adverse Event
    Injury ·COLOPLAST A/S·Product code OTO·August 21, 2013

    PALMAZ GENESIS AMIIA

    FDA Adverse Event
    Malfunction ·CORDIS EUROPA, N.V.·Product code FGE·September 23, 2010

    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