BEUDAMED
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    COROMETRICS MODEL 173 FETAL MONITOR

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

    CL-DC20, CL-DC21

    FDA 510(k)
    FDA Class 2 ·Dental

    AMYLASE TEST (AML) ITEM NUMBER: 65404

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AFX SYSTEM

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

    RESTORE RECHARGABLE NEUROSTIMULATOR

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

    SPRINT QUATTRO

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·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