BEUDAMED
    13 results · 24ms · Sources: EU EUDAMED, US FDA

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    1 Series Phototherapy Equipment

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Vu aPod™ - L

    FDA UDI
    Seaspine Orthopedics Corporation·10889981046378·LATERAL TRIAL, WIDE, STANDARD, 8mm X 23mm X 40mm

    VITAL SCIENTIFIC PT WITH CALCIUM

    FDA 510(k)
    FDA Class 2 ·Hematology

    LEXUS CERVICAL INTERVERTEBRAL BODY FUSION CAGE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BI-METRIC/X POR NC 11X135

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·February 15, 2018

    M2A-MAGNUM MOD HD SZ 52MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·November 9, 2017

    M2A-MAGNUM PF CUP 58ODX52ID

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·November 9, 2017

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·October 30, 2008

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·August 23, 2011

    EMERSON HEATING LAMP

    FDA Adverse Event
    PHILIPS RESPIRONICS (FORMERLY J.H. EMERSON CO.)·Product code ILY·July 1, 2013

    OXYGENATOR WITH INTEGRATED HEAT EXCHANGER

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·February 25, 2019

    NV GXL LNR, NEUTRAL, 28MM ID, GROUP 2 CUPS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·November 23, 2022

    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