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

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    PEBA ANCHOR/SUTURE COMBINATION

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OSTAPEK VBR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PINN SECTOR HA ACET CUP 48MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910 ·Product code KWA·February 21, 2013

    530G INSULIN PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·July 31, 2014

    PFC SIGMARP STB TB IN 2.5 15.0

    FDA Adverse Event
    Injury ·DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS, INC.·Product code NJL·January 25, 2011

    BD TRUCOUNT TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·July 13, 2021

    BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·May 20, 2024

    BD TRUCOUNT TUBES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code GKZ·July 15, 2021

    BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·November 30, 2023

    BD TRUCOUNT TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 24, 2020

    BD TRUCOUNT¿ TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·May 2, 2025

    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