BEUDAMED
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    Raycell Mk2

    FDA 510(k)
    FDA Unclassified ·Unknown

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517577856·CoRoent Ant TLIF PEEK, 16x11x32mm 4°

    Ceramco® II Silver™

    FDA UDI
    Dentsply International Inc.·D0011613240·

    Symmetry Rochester Ochsner

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482056219·Symmetry® Forceps, Rochester Ochsner, Curved, 1...

    CUSA EXCEL 23KHZ TUBING SET

    FDA Adverse Event
    Malfunction ·INTEGRA LIFESCIENCES(IRELAND)·Product code LFL·December 20, 2016

    GE ECHOPAC MODEL BT10

    FDA 510(k)
    FDA Class 2 ·Radiology

    EMT QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH, SERIES 1-7

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

    VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 46

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·June 21, 2018

    SPRINT QUATTRO SECURE MRI SURESCAN

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·October 10, 2014

    SCRDRIVERSHAFT T25 F/URS

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HXX·June 11, 2013

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    FDA Adverse Event
    Malfunction ·HAMILTON BONADUZ AG·Product code MMH·July 13, 2011

    Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024

    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