BEUDAMED
    9 results · 28ms · 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 ×

    ROVO Mechanical Thrombectomy Device

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VALULINE

    FDA UDI
    BENCO DENTAL SUPPLY CO.·00366975010292·

    TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP

    FDA 510(k)
    FDA Class 2 ·Neurology

    EDWARD PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LIGASURE ATLAS HANDSWITCHING 20CM

    FDA Adverse Event
    Malfunction ·COVIDIEN LP (US SURGICAL)·Product code GEI·October 31, 2008

    COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE BASEPLATE

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWS·August 23, 2011

    M2A-MAGNUM PF CUP 58ODX52ID

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·July 11, 2013

    BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    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