BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    SIL-SLIP FLAT SUCTION DRAIN

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

    LIGHT CURE DENTIN AND LINER BASE PRODUCT LINE

    FDA 510(k)
    FDA Class 2 ·Dental

    DESERET GUIDEWIRE INTRODUCER III

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AC POWER MODULE

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·November 11, 2010

    SCREW

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·January 23, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 10, 2014

    Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAXL 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