BEUDAMED
    7 results · 27ms · Sources: EU EUDAMED, US FDA

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    ORION SUCTION CATHETER KIT WITH STERILE WATER

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    MODIFICATION TO HEALTH BUDDY WITH DEVICE CONNECTIVITY

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EmboGuide

    FDA 510(k)
    FDA Class 2 ·Radiology

    R/R MICRODRILL STRAIGHT ATT

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code ERL·December 22, 2010

    TOTALCARE BARIATRIC PLUS BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·January 4, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 17, 2014

    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