BEUDAMED
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    HBL Blade Assembly

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Blade Scalpel

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113561·IMPLANT BLADE 6.2MM (BX/5)

    KULAVAC

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

    KSEA MEDI PACK

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

    ENDURON 10D 58 OR 70ODX32ID

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code HRY·November 5, 2008

    3002 SECURE II

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·July 13, 2011

    EZ-PRO R4 AMBUL COT OBS(5/08)

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·July 12, 2013

    COREVALVE TRANSCATHETER AORTIC VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·April 27, 2022

    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