BEUDAMED
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    3Dicom MD

    FDA 510(k)
    FDA Class 2 ·Radiology

    Caplugs/Evergreen

    FDA UDI
    CAPlugs·00810044201079·15 mL Sterile Centrifuge Tubes with Screw Caps

    PENTAX EPK-I5010 VIDEO PROCESSOR

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

    PORTA SOLDER 1080 W

    FDA 510(k)
    FDA Class 2 ·Dental

    HEARTMATE II LVAS

    FDA Adverse Event
    Death ·THORATEC CORP.·Product code DSQ·October 31, 2014

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·August 25, 2011

    PK DISSECTING FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·July 12, 2013

    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