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

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    HYDROTOWER MANAGEMENT SYSTEM, MODEL 4-750-00

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SUNGLASSES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    CALCIUM TEST ITEM NUMBER: 65409

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AFX SYSTEM

    FDA Adverse Event
    Injury ·ENDOLOGIX, INC.·Product code MIH·March 7, 2013

    ENDOPATH** XCEL* TROCAR

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·February 16, 2011

    CAPSUREFIX MRI SURESCAN

    FDA Adverse Event
    Injury ·MPRI·Product code NVN·August 8, 2014

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021