BEUDAMED
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    SYNGO.VIA MI WORKFLOWS

    FDA 510(k)
    FDA Class 2 ·Radiology

    LINEAR ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 7, 2024

    PILOT TUBE REPAIR KIT

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ENDOBOY

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LJS·August 24, 2016

    ISOLINE

    FDA Adverse Event
    Injury ·SORIN GROUP ITALIA SRL·Product code MRM·May 24, 2013

    LIBERTE' MONORIAL CORONARY STENT DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MAF·August 20, 2008

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    FDA Adverse Event
    Injury ·UNITED STATES SURGICAL·Product code GDW·June 8, 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

    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