BEUDAMED
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    BISFIL-M(LIGHT CURABLE ANTERIOR COMPOSITE)

    FDA 510(k)
    FDA Class 2 ·Dental

    APEX CR Knee

    FDA UDI
    Omni Life Science, Inc.·00841690111726·Retaining Bolt Congruent or Ultra, Modular Tibi...

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707030812·WEB 1ST MOL BANDS W/G8325-03 UL 1

    Legacy™ Cover Screw

    FDA UDI
    IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307111009·

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209107223·

    Integrated Spine System

    FDA UDI
    Ortho Development Corporation·00822409030972·Diameter 8.5 x 30 mm Pedicle Screw

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523121151·8.5mm Tap Cannulated

    LEECO TESTO-QUANT DIAGNOSTIC KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    APEX KNEE SYSTEM

    FDA Adverse Event
    Injury ·OMNILIFE SCIENCE INC.·Product code JWH·March 3, 2023

    ACCU-CHEK ® TENDER INFUSION SET

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FPA·June 6, 2014

    ACCU-CHEK ® AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·October 5, 2010

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·November 30, 2012

    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