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

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    Tandry Locking Plate System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Philips

    FDA UDI
    Sbo Hearing A/S·05714464032686·HEARLINK 5030 MNR T TP

    Cooley Anastomosis Clamp 17cm

    FDA UDI
    Geister Medizintechnik GmbH·04057034062654·Cooley Anastomosis Clamp 17cm

    Z-800 INFUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CODONICS EP-1000 MEDICAL COLOR DRY IMAGERS

    FDA 510(k)
    FDA Class 2 ·Radiology

    7" (18 CM) APPX 0.45 ML, PRESSURE INFUSION (400PSIG) EXT SET W/ MICROCLAVE® CLEA

    FDA Adverse Event
    Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FPA·January 31, 2024

    PARADIGM INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LZG·November 6, 2014

    VIBRANT SOUNDBRIDGE

    FDA Adverse Event
    Injury ·VIBRANT MED-EL HEARING TECHNOLOGY GMBH·Product code MPV·August 17, 2011

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 16, 2013

    M2A-MAGNUM MOD HD SZ 46MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·October 9, 2018

    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