BEUDAMED
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    COBE CENTRYSYSTEM 3 BICART OPTION KIT

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

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111084836·

    MODIFIED STERILIZATION OF DRILLS, BURRS, TREPHINES

    FDA 510(k)
    FDA Class 2 ·Neurology

    SEARS MODEL LM9091 IN-THE-EAR HEARING INSTRUMENT

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    QUICKFLEX MICRO LV LEAD

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·January 9, 2013

    UNKNOWN DEPUY ASR HIP

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDI·November 19, 2010

    ENDOTAK RELIANCE

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code LWS·July 1, 2014

    Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167

    FDA Enforcement
    Class II ·Terminated·Mako Surgical Corporation·August 12, 2020

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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