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

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    SPS 1550 SINGLE NEEDLE PATIENT SYSTEM

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

    ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SPIFE CK KIT, MODEL 3332, 3333

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·January 14, 2014

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·December 13, 2010

    POSEY KEEPSAFE DELUXE

    FDA Adverse Event
    Malfunction ·J. T. POSEY CO.·Product code KMI·December 28, 2012

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015