BEUDAMED
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    Nutra Face Lift Model PE8050

    FDA 510(k)
    FDA Class 2 ·Neurology

    HHM

    FDA UDI
    Oticon A/S·05707131281685·H150V2, BTE 13 WL 100 TC HHM

    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

    BIOMET KNEE SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304009653·

    Biomet® Knee System

    FDA UDI
    Biomet Orthopedics, LLC·00887868344329·

    PENUMBRA CATHERER 025

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FETAL ULTRASOUND AND TOCODYNAMOMETER TRANSDUCERS

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

    GMK-SPHERE 02.07.1204R TIBIAL TRAY FIXED CEMENTED SIZE 4 R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 2, 2023

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 29, 2019

    GMK SPHERE IMPLANTS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 4, 2025

    THE EMAX 2 PLUS SYSTEM

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 8, 2014

    ECHELON 60

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 6, 2011

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code NIQ·June 6, 2013

    GMK-SPHERE 02.07.1206L TIBIAL TRAY FIXED CEMENTED SIZE 6 L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 20, 2022

    VANGUARD DCM CR TIBIAL BEARING 12MM X 63/67MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·November 8, 2016

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 22, 2021

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 30, 2019

    BMET ARCOM AP PAT W/WIRE 31MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·March 7, 2018

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 30, 2022

    MAXIM DCM POP-TOP TIBIAL CR BEARING

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·December 7, 2017