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

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    Zimmer NexGen Complete Knee Solution Tibial and Femoral Augments

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·14026704920904·

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704284423·WEITLANER RETRACTOR 4" BLUNT

    THE BUZZ FACIAL TONING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    NOVABONE-BIOACTIVE SYNTHETIC GRAFT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACRYSOF RESTOR

    FDA Adverse Event
    Malfunction ·ALCON -IRVINE TECH CTR·Product code HQL·October 6, 2014

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA INC·Product code LWP·June 7, 2013

    LSLF EXT SET W CLV

    FDA Adverse Event
    Malfunction ·HOSPIRA LTD.·Product code FPK·June 27, 2011

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012