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    Laser Thermal Therapy Kit

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    NXSTAGE DOSING CALCULATOR

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 10, 2024

    PULSE GEN MODEL 101

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·November 7, 2008

    5 FR D/L POWERPICC SOLO FULL TRAY

    FDA Adverse Event
    Injury ·C. R. BARD INC. (BASD)·Product code LJS·August 15, 2011

    LYNX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 16, 2013

    CT SCREW DOUBLE LEAD LOCK, Ø3.5MM X 26MM

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code KTW·March 3, 2025

    CODMAN Disposable Perforator, 14mm. Cranial perforator.

    FDA Enforcement
    Class I ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025

    Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external programming system used to change stimulation settings. The generator is an implantable, multi-programmable pulse generator that delivers electrical signals to the vagus nerve through the lead. The generator is housed in a hermetically sealed titanium case and is powered by a single battery. Electrical signals are transmitted from the generator to the vagus nerve by the lead. The lead and the generator make up the implantable portion of the VNS Therapy System. The VNS Therapy Programming System includes a computer pre-installed with VNS Therapy programming software and a programming wand. The physician uses the programming system to read and change generator settings. The Model 1000 Generator was commercially approved for distribution in the U.S. on October 3, 2017 via PMA P970003/S210. Component: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS).

    FDA Enforcement
    Class II ·Ongoing·LivaNova USA, Inc.·February 5, 2025