BEUDAMED
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    Pre-Formed Penile Silicone Block

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    K-Systems

    FDA UDI
    Coopersurgical, Inc.·00888937025033·G95 Mini Incubator

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613085346·Gerald Bayonet Bipolar Forcep 7" (178mm) Insula...

    STARFLOW HV

    FDA 510(k)
    FDA Class 2 ·Dental

    LDR SPINE SPINETUNE TL SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ONE TOUCH PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code NBW·October 30, 2008

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·August 23, 2011

    IMPAX CV REPORTING

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORPORATION·Product code LLZ·July 8, 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

    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025