BEUDAMED
    7 results · 22ms · Sources: EU EUDAMED, US FDA

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    DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ALBUMIN TEST (ALB) ITEM NUMBER: 65401

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    WRP FOLEYCATH

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

    AFX SYSTEM

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

    RESTORE ADVANCED RECHARGEABLE

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·January 13, 2011

    XENFORM

    FDA Adverse Event
    Other ·TEI BIOSCIENCES INC.·Product code FTM·July 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