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

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    LABSYSTEMS UNISKAN

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    AQUAPAK NEBULIZER ADAPTORS/RESERVOIRS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PASCO MIC AND MIC/ID PANELS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    EXTENSION SET 30IN

    FDA Adverse Event
    Malfunction ·HOSPIRA INC.·Product code FPA·June 3, 2009

    APM/AIM PUMP SET W/C

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·September 28, 2010

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 30, 2014

    CLICK X

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code NKB·November 21, 2012

    SPECIALTY XIA II SHAFT

    FDA Adverse Event
    Malfunction ·STRYKER SPINE BORDEAUX·Product code LXH·September 7, 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