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

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    LARYNGASCOPES, FORCEPS, MICRO SUCTION TUBE & REFLE

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    Legacy™3 Implant

    FDA UDI
    IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307102045·Ø3.7 x 8 Platform 3.5mmD

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209122639·

    Stainless Steel Wire

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746047749·WIRE SS UPPER 018 X 022 BONWILL HAWLEY 10/PK

    Halyard Black-Orange Powder-Free Nitrile Exam Glove

    FDA 510(k)
    FDA Class 1 ·General Hospital

    COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTE

    FDA 510(k)
    FDA Class 2 ·Hematology

    PANORAMA CENTRAL STATION WITH TELEPACK

    FDA Adverse Event
    Malfunction ·MINDRAY DS USA, INC.·Product code MHX·April 16, 2014

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·October 1, 2010

    CAPSURE

    FDA Adverse Event
    Injury ·RICE CREEK MFG·Product code DTB·December 3, 2012

    LEGACY3 IMPLANT 3.7MMD X 8MML SBMPRODUCT CODE 853708

    FDA Adverse Event
    Injury ·IMPLANT DIRECT SYBRON MANUFACTURING LLC·Product code DZE·February 19, 2018

    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