BEUDAMED
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    LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Bosworth

    FDA UDI
    Keystone Industries·H66809214211·WONDER WEDGES Assorted, Natural (100)

    PADTAC ELECTROPHYSIOLOGY RECORDING CATHETERS, JUNCTION CABLE CONNECTOR & CABLE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT)

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

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·January 18, 2013

    ASKU

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code DTB·December 13, 2010

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·February 6, 2014

    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