BEUDAMED
    13 results · 20ms · Sources: EU EUDAMED, US FDA

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    EPIQ Series Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111152306·SKLIT LITT STITCH SCISS 5 1/2"

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197536004·HAUSMANN Intestinal Clamps,angled shanks 190mm,...

    MYPATCH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)

    FDA 510(k)
    FDA Class 2 ·Dental

    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

    CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code HWE·December 3, 2025

    PROXIMATE PPH PROCEDURE SET

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code GDW·November 10, 2008

    ACRYSOF RESTOR

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LTD. / HUNTINGTON·Product code MFK·August 26, 2011

    PFC*SIGMA/OV DOME PAT 3 PEG,32

    FDA Adverse Event
    Injury ·9616671 DEPUY (IRELAND)·Product code JWH·July 17, 2013

    various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System Vanguard Deep Dish Rotating Platform Biomet CP Bearings Product Usage: For use in total knee arthroplasty. Limb salvage joint reconstruction. Partial knee replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·April 26, 2017

    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