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

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    RIONET HEARING AID HB-69HT

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    Endo-Model SL Knee Prosthesis System

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575383658·Modular Stem

    TRACTION SYSTEM, DIGIT-TRAC 930

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    LENSAR Laser System - fs 3D (LLS-fs 3D)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·January 25, 2021

    M2A-TAPER LINER SZ 41/32

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code LZO·June 5, 2014

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·November 13, 2012

    SYNVISC ONE (HYLAN G-F 20) INJECTION

    FDA Adverse Event
    Injury ·GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·September 30, 2010

    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