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

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    DYNAMIC CONDYLAR SCREW OR D.C.S.

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FOX PLUS PTA CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LUOFUCON SILVER PU ANTIBACTERIAL FOAM DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code EZW·May 30, 2014

    NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code OAD·November 20, 2012

    PATIENT ROOM WALL SAVER RECLINER

    FDA Adverse Event
    Malfunction ·STRYKER CORP., MEDICAL DIVISION·Product code FRK·September 10, 2010

    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