BEUDAMED
    17 results · 21ms · Sources: EU EUDAMED, US FDA

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    Intimate Rose Vaginal Dilators

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776184469·LABORDE TRACHEAL DILATOR BLADE

    Integra® Miltex®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780498803·Integra® Miltex® LaBorde Tracheal Dilator, 5-1/...

    CLEARFIL DC ACTIVATOR; CLEARFIL DC ACTIVATOR TRIAL

    FDA 510(k)
    FDA Class 2 ·Dental

    CEMEX SYSTEM FAST

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BI-METRIC/X POR COLLAR

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·November 22, 2019

    BI-METRIC/X POR COLLAR 13X145

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·November 22, 2019

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·November 17, 2008

    ACCU-CHEK ® AVIVA TEST STRIPS

    FDA Adverse Event
    Injury ·ROCHE DIAGNOSTICS·Product code LFR·September 1, 2011

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 17, 2013

    DEXCOM G5

    FDA Adverse Event
    Injury ·DEXCOM·Product code MDS·March 29, 2018

    PSX INTERBODY SYSTEM

    FDA Adverse Event
    Injury ·ALPHATEC SPINE, INC.·Product code MAX·April 29, 2025

    M2A-MAGNUM PF CUP 56ODX50ID

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·November 22, 2019

    TT AUGMENTED 360 BASEPLATE #S-R 15°

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code PHX·January 3, 2024

    MENTOR SMOOTH ROUND MODERATE PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·September 12, 2018

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Enforcement
    Class II ·Ongoing·Meridian Bioscience Inc·August 3, 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