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

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    SCALP HYDROBATH/TREATMENT DELIVERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    URIC ACID REAGENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code KNK·April 15, 2011

    ARGYLE UNIVERSAL POOLE SUCTION TUBE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    nextaro Transfer System, nextaro va

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SYMBIQ DCHANNEL 3.01

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·May 23, 2014

    INOMAX DS (DELIVERY SYSTEM)

    FDA Adverse Event
    Malfunction ·INO THERAPEUTICS LLC/IKARIA·Product code MRN·October 20, 2010

    CAPSURE EPI

    FDA Adverse Event
    Malfunction ·RICE CREEK MFG·Product code DTB·December 21, 2012

    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