BEUDAMED
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    CLEARinse CTS Specimen Collection and Transport System

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Symmetry Surgical®

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482059272·Symmetry® Retractor, Roux "S", Double-Ended, Sm...

    FIREBIRD SI Fusion System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    T4/T5 HYTREL TOGAS

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

    CODMAN EXTERNAL DRAINAGE SYSTEM III

    FDA Adverse Event
    CODMAN & SHURTLEFF, INC/ MEDOS S.A.·Product code JXG·November 5, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 24, 2011

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 1, 2013

    Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025

    Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003 2. Allura Xper FD10/10, Model Number 722005 3. Allura Xper FD20, Model Number 722006 4. Allura Xper FD20 Biplane, Model Number 722008 5. Allura Xper FD10, Model Number 722010 6. Allura Xper FD10/10, Model Number 722011 7. Allura Xper FD20, Model Number 722012 8. Allura Xper FD20 Biplane, Model Number 722013 9. Allura Xper FD20 OR Table, Model Number 722023 10. Allura Xper FD10, Model Number 722026 11. Allura Xper FD10/10, Model Number 722027 12. Allura Xper FD20, Model Number 722028 13. Allura Xper FD20/10, Model Number 722029 14. Allura Xper FD20 OR Table, Model Number 722035 15. Allura Xper FD20/20, Model Number 722038 16. Allura Xper FD20/15, Model Number 722058 17. Allura Xper FD20/15 OR Table, Model Number 722059.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·September 10, 2025

    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