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

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    RADID DRUG SCREEN 5-PANEL TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    artegral life

    FDA UDI
    Merz Dental GmbH·D7091993151·anteriors; shade A4; mould UCL

    CARDIAC TRIAD NEW DETECTOR OPTION

    FDA 510(k)
    FDA Class 2 ·Radiology

    INTERVERTEBRAL DISC RONGEUR

    FDA 510(k)
    FDA Class 2 ·Neurology

    MCGHAN BREAST IMPLANT SALINE

    FDA Adverse Event
    Death ·(MCGHAN) MENTOR·Product code FWM·March 5, 2013

    PUMP,COLLEAGUE SINGLE CHANNELCOLOUR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·February 16, 2011

    CAPSUREFIX MRI SURESCAN

    FDA Adverse Event
    Injury ·MPRI·Product code NVN·August 8, 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