BEUDAMED
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    ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT

    FDA 510(k)
    FDA Class 2 ·Immunology

    Modulus

    FDA UDI
    Nuvasive, Inc.·00195377049315·Modulus ALIF Trial, 6x34x28mm 10°SmDeep

    Polystar Selection EDITION

    FDA UDI
    Merz Dental GmbH·D7091982121·posteriors; shade D4; size XL; lower jaw

    Sklar

    FDA UDI
    SKLAR CORPORATION·10649111003066·YASARGIL RASP FWD CUT 7.25 INCHES

    EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL # EPS08005

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition

    FDA 510(k)
    FDA Class 2 ·Neurology

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 8, 2013

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·August 5, 2014

    RENAL - DISPOSABLE

    FDA Adverse Event
    Injury ·Product code KDJ·February 9, 2011

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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