BEUDAMED
    24 results · 23ms · Sources: EU EUDAMED, US FDA

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    Catalyst OrthoScience CSR Shoulder System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    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

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M930719181100·O'Brien Curette 18" 11mm

    OneLIF™

    FDA UDI
    Novapproach Spine LLC·G07001111918110·Trial-OneLIF Interbody, Small, 19 Degree, 18mm ...

    OneLIF™

    FDA UDI
    Novapproach Spine LLC·G07001011918110·OneLIF Interbody, Small, 19 Degree, 18mm X 11mm

    BENDINI(TM) SPINAL ROD BENDING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    PROTEGRITY SMT LATEX SURGICALGLOVES

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·April 24, 2025

    STEM: M-VIZION PROXIMAL BODY 20MM L 80MM STD

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·May 17, 2021

    STEM: M-VIZION PROXIMAL BODY Ø20MM L 60MM STD WITH HOLES

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·August 19, 2022

    TENDRIL ST

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·January 13, 2014

    UNKNOWN SUTURE PRODUCT

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code GAS·July 28, 2011

    M2A-MAGNUM PF CUP 54ODX48ID

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·June 26, 2013

    M-VIZION FEMORAL REVISION SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·July 29, 2025

    M-VIZION FEMORAL REVISION SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·March 27, 2025

    M-VIZION PROXIMAL BODY HANDLE

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code LXH·March 28, 2024

    M-VIZION FEMORAL REVISION SYSTEM

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code LZO·May 28, 2026

    STEM: M-VIZION PROXIMAL BODY 20MM L 50MM LAT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·February 24, 2021

    M-VIZION INSERTER ROD

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code LXH·May 28, 2024

    M-VIZION FEMORAL REVISION SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·September 16, 2025