BEUDAMED
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    AJAX DENTAL UNIT

    FDA 510(k)
    FDA Class 1 ·Dental

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B16741322450·

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1674132245060·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970577·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970478·

    CARE ZY5BA OXYGEN CONCENTRATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ARTHREX FIBERTAPE (TM), 2MM, ARTHREX FIBERTAPE (TM), 3MM, ARTHREX FIBERTAPE (TM), 4MM, MODELS AR-7237, AR-7238, AR-7239

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SET, ADMINISTRATION, INTRAVASCULAR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·June 6, 2016

    AEQUALIS REVERSED BASE PLATE TA6V LONG PEG WITH HA

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code KWS·April 19, 2023

    STOPCOCK MANIFOLD GANGS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FMG·June 17, 2020

    LONG NAIL KIT R2.0, TI, LEFT GAMMA3 Ø11X380MM X 125°

    FDA Adverse Event
    Injury ·STRYKER TRAUMA KIEL·Product code HSB·May 29, 2013

    3E DIRECT ACCESS MEDICAL

    FDA Adverse Event
    Malfunction ·CREAGH MEDICAL LTD·Product code DQY·June 1, 2011

    EASYTRAK 2

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NIK·October 1, 2014

    DRIVING CAP/THREADED

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code LXH·November 15, 2016

    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

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015