BEUDAMED
    14 results · 22ms · Sources: EU EUDAMED, US FDA

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    CustMBite Dental Guard

    FDA 510(k)
    FDA Unclassified ·Unknown

    VANGUARD SSK PSC FEMORAL STEM SCREW

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HRY·December 4, 2019

    Vanguard® SSK Knee System

    FDA UDI
    Biomet Orthopedics, LLC·00880304440418·

    VANGUARD SSK 360 LEFT FEMORAL

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·January 15, 2020

    RUMBLE TUFF

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Internal Distraction - Sterile

    FDA 510(k)
    FDA Class 2 ·Neurology

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·June 21, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 28, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 17, 2014

    MIDAS REX MR8

    FDA Adverse Event
    Malfunction ·MDT POWERED SURGICAL SOLUTIONS·Product code HBC·May 9, 2025

    MOTOR MR8 ELECTRIC

    FDA Adverse Event
    Malfunction ·MDT POWERED SURGICAL SOLUTIONS·Product code HBB·February 24, 2022

    VANGUARD SSK FEMORAL

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code JWH·October 12, 2017

    BIOMET OFFSET ADAPTER

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code JWH·October 12, 2017

    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