BEUDAMED
    12 results · 21ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Zirconia Block

    FDA 510(k)
    FDA Class 2 ·Dental

    APEX PS Knee

    FDA UDI
    Omni Life Science, Inc.·00841690113768·PS-C Insert, Size 5 x 20mm

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111157295·GOLDMAN-FOX SCISS 5" CVD SERR

    FlexiNylon cartridges Light Red

    FDA UDI
    PERFLEX LTD·07290110506629·5 identical cartridges sealed in a vacuum bag ;...

    Gold Anchor

    FDA UDI
    Naslund Medical AB·07340145700988·22G (0.7mm) 25 cm needle with 0.40x20 mm marker

    DIGITAL THERMOMTER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    U2 ACETABULAR CUP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Ambassador Cervical Plate System

    FDA UDI
    Choice Spine, LP·00840996161053·AMBASSADOR,DRILL,2.5x20

    SAFETY FLEX CUFFED

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY TYCO HEATLHCARE·Product code BTR·November 6, 2008

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·August 25, 2011

    LEAD MODEL 302

    FDA Adverse Event
    Injury ·CYBERONICS INC·Product code LYJ·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