BEUDAMED
    11 results · 23ms · Sources: EU EUDAMED, US FDA

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    M.U.S.T. MINI Posterior Cervical Screws System Extension

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SIMPLICITY

    FDA 510(k)
    FDA Class 2 ·Dental

    CHOICE SPINE VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACRYSOF

    FDA Adverse Event
    Other ·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·October 31, 2008

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MALTA·Product code FPA·August 23, 2011

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 11, 2013

    M2A-MAGNUM PF CUP 58ODX52ID

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·July 29, 2020

    TAPERLOC POR FMRL 17.5X155

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·July 29, 2020

    M2A-MAGNUM 52-60MM TPR INS STD

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·July 29, 2020

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    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