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

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    FDA 510(k)
    FDA Unclassified ·Unknown

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180168015·Posterior Glenoid Elevator 3/4", Overall Length...

    DANEK PLATE AND SCREW

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK MFG·Product code HRS·March 15, 2000

    OXYGEN GENERATOR LIQUEFIER - (OGL)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ELECSYS PRECICONTROL TROPONIN T

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    21 G X 1.25 IN. BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code FMI·February 9, 2017

    OPTILITE® FREELITE® KAPPA FREE KIT

    FDA Adverse Event
    Injury ·THE BINDING SITE LIMITED·Product code DFH·March 30, 2026

    OPTILITE® FREELITE® KAPPA FREE KIT

    FDA Adverse Event
    Injury ·THE BINDING SITE LIMITED·Product code DFH·March 31, 2026

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 21, 2025

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code FMI·December 5, 2017

    7700

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 1, 2011

    RESTORE

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 6, 2014

    SERIES 20000 LEGACY

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·July 15, 2013

    AIR DERMATOME HANDPIECE

    FDA Adverse Event
    Injury ·ZIMMER SURGICAL·Product code GFD·April 15, 2014

    BIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile, Item 431185.

    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