BEUDAMED
    7 results · 27ms · Sources: EU EUDAMED, US FDA

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    ANTINUCLEAR ANTIBODY (ANA) SCREENING TEST KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    MODEL STT-100

    FDA 510(k)
    FDA Class 2 ·Radiology

    GRADUATED CYLINDER OF EXTERNAL DRAINAGE SET

    FDA 510(k)
    FDA Class 2 ·Neurology

    CYSTO/BLADDER IRRIGATION SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code LJH·December 4, 2010

    BRIGHTVIEW XCT IMAGING SYSTEM

    FDA Adverse Event
    PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.·Product code KPS·January 10, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 4, 2014

    Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Alcon Research LLC·August 28, 2024