BEUDAMED
    18 results · 22ms · Sources: EU EUDAMED, US FDA

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    Rosa Knee System

    FDA 510(k)
    FDA Class 2 ·Neurology

    Andwin Scientific

    FDA UDI
    Andwin Scientific·00187207000122·PAPKIT, 5010X, 1 Slide, Scraper & Brush

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114087·SIMCOE CORTEX EXTRACTOR (PK/10)

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·04546540177117·BIPOLAR FORCEPS

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code QJR·July 17, 2020

    CRESCENT TINNITUS RETAINING SOUND GENERATOR

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    CLEANSER ROOT CANAL

    FDA 510(k)
    FDA Unclassified ·Unknown

    SURESTEP

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·July 31, 2002

    T:SLIM G5 SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OYC·June 21, 2018

    ACCU-CHEK COMFORT CURVE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS CORP.·Product code CFR·July 22, 2006

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 10, 2024

    ACCU-CHEK AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code NBW·September 7, 2006

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 18, 2015

    TALENT ABDOMINAL STENT GRAFT SYSTEM T-HYDRO

    FDA Adverse Event
    Death ·MEDTRONIC CARDIOVASCULAR·Product code MIH·November 13, 2008

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JGS·September 1, 2011

    MEDSTREAM PUMP 40 ML

    FDA Adverse Event
    Injury ·CODMAN & SHURTLEFF,INC.·Product code LKK·July 16, 2013

    CUSTOM DEFINED PRODUCT

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·November 7, 2012

    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