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

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    DETER. OF HEMOGLOBIN A2 USING THE DIAMAT

    FDA 510(k)
    FDA Class 2 ·Hematology

    LA Replaceable Cover (4 Hr) 5-Pk

    FDA UDI
    SYNERON MEDICAL LTD·17290109952212·LA Replaceable Cover (4 Hr) 5-Pk, Velashape III

    LA Replaceable Cover (4 Hr) 5-Pk

    FDA UDI
    Candela Corporation·00817495023878·LA Replaceable Cover (4 Hr) 5-Pk, Velashape III

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228751021·GC Initial™ Zr-FS Enamel Opal EOP2, 20g

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556708115·GC Initial™ Zr-FS Enamel Opal EOP2, 20g

    MONARK 869 ERGOMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IMMPULSE COATED TUBE PHENYTOIN ASSAY REAGENTS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    TRIDENT 0° POLY INSERT 28MM ID

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code LPH·June 16, 2014

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 19, 2010

    RESOLUTE INTEGRITY RX

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code NIQ·December 17, 2012

    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), product code 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 include pharmaceutical drugs, blood, blood products and mixture of required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluid space. Spectrum Infusion Pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by the user. The Spectrum and Spectrum with Master Drug Library is suitable for many user facility applications such as but not limited to hospitals, outpatient care areas, homecare and ambulatory care services. 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. Parameter programming requires trained healthcare professional confirmation of limits and drug therapy to the physician s directive.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·May 8, 2019