BEUDAMED
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    Langston dual lumen catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FRANKLIN SPORTS, INC.

    FDA registration
    FRANKLIN SPORTS, INC.·2 products·🇺🇸 United States

    FULLY AUTOMATIC WIRELESS BLOOD PRESSURE WRIST MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SEER LIGHT COMPACT DIGITAL HOLTER RECORDER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    M2A-MAGNUM MOD HD SZ 44MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·March 20, 2019

    STRYKEFLOW2 WITH DISPOSABLE TIP (6BX)

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY-SAN JOSE·Product code LJH·November 3, 2014

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·August 17, 2011

    JUVEDERM ULTRA PLUS XC TSK US

    FDA Adverse Event
    Injury ·ALLERGAN·Product code LMH·July 9, 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