BEUDAMED
    7 results · 25ms · Sources: EU EUDAMED, US FDA

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    CARBON DIOXIDE CALIBRATOR II

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LIFEPAK 12

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    OSIGRAFT

    FDA Adverse Event
    Other ·OLLYMPUS BIOTECH·Product code MPY·May 12, 2014

    UNKNOWN DEPUY ASR ACETABULAR CUP

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·November 20, 2012

    SPRINT FIDELIS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·September 22, 2010

    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