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

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    aPROMISE X

    FDA 510(k)
    FDA Class 2 ·Radiology

    Sonic

    FDA UDI
    Sbo Hearing A/S·05714464011278·SOUNDLINK 2 2.3.0 ANDROID

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180111981·5 MM DIA., 33 CM, INSULATED KNIFE ELECTRODE, R...

    VEO® Lateral Interbody Fusion System

    FDA UDI
    Choice Spine, LP·00840996134637·LATERAL,STRAIGHT CUP CURETTE

    DILATOR TUBE SET

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

    MODEL 733HC GRAVITY/VACUUM STEAM STERILIZER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 13, 2025

    TAPERLOC POR FMRL 16X152

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·November 13, 2018

    M2A-MAGNUM 52-60MM TPR INSRT-3

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·November 13, 2018

    M2A-MAGNUM PF CUP 60ODX54ID

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·November 13, 2018

    TARGETING SLEEVE GAMMA3 200

    FDA Adverse Event
    Malfunction ·STRYKER TRAUMA KIEL·Product code HSB·November 3, 2014

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 23, 2011

    RESOLUTE INTEGRITY RX

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIQ·July 11, 2013

    M2A-MAGNUM RECAP CUP 62ODX56ID

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LZO·June 30, 2022

    M2A-MAGNUM MOD HD SZ 56MM 56MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·June 30, 2022

    TIMESH STRAIGHT PLATE 1H X 1H 8 MM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROSURGERY·Product code JEY·September 9, 2020

    M2A-MAGNUM 52-60MM TPR INSRT-3 0/-3MMT1

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·June 30, 2022

    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