BEUDAMED
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    LessRay System

    FDA 510(k)
    FDA Class 2 ·Radiology

    CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL

    FDA 510(k)
    FDA Class 2 ·Hematology

    HEANY INDUSTRIES INC DENTAL XIRCONIA

    FDA 510(k)
    FDA Class 2 ·Dental

    BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·July 22, 2022

    NEXIVA DIFFUSICS

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·March 30, 2026

    ENDURANT

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·October 15, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 17, 2013

    FINELINE II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·July 23, 2011

    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