BEUDAMED
    13 results · 19ms · Sources: EU EUDAMED, US FDA

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    Mariner RDX System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112793·BARRON VACUUM PUNCH 8.5MM

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707066422·LIGAT SLIDE LOW FRICTION ICE SMALL

    APEX PS Knee

    FDA UDI
    Omni Life Science, Inc.·00841690113423·PS-C Insert, Size 1 x 10mm

    NA

    FDA UDI
    STRYKER CORPORATION·04546540374134·Non-Sterile Small Battery

    N/A

    FDA UDI
    STRYKER CORPORATION·07613327482690·System 9 Non-Sterile Battery, Small

    ACON ON CALL VIVID PAL BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    KAWASUMI LABORATORIES ANTINEEDLE STICK PROTECTOR FOR USE WITH PORT ACCESS INFUSION SETS.

    FDA 510(k)
    FDA Class 2 ·General Hospital

    INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FTR·July 7, 2025

    ENDO CLIP 5MM CLIP APPLIER

    FDA Adverse Event
    Injury ·NORTH HAVEN - USS·Product code GDO·November 5, 2008

    MEDISENSE OPTIUM

    FDA Adverse Event
    Malfunction ·Product code NBW·August 24, 2011

    HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC.·Product code KNQ·July 2, 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