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

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    ARTHREX INSTRUMENTS (WRIST)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    M-LINK

    FDA 510(k)
    FDA Class 2 ·Radiology

    SAPPHIRE PREMIERE

    FDA 510(k)
    FDA Class 2 ·Neurology

    MINIARC SINGLE-INCISION SLING

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code PAH·January 16, 2013

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·December 14, 2010

    ISOFLEX P

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·July 10, 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