BEUDAMED
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    Erchonia Zerona Z6 OTC

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

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169631823·DISTRACTOR 2143007 4MM COBB DISTRACTOR

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756614580·Knee Immobilizer

    V. Mueller

    FDA UDI
    STERIS CORPORATION·10885403279249·V. Mueller DISPOSABLE BIPOLAR FORCEPS

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707011651·CALIBRA 1ST MOL BANDS W/G8025-03 n.UL 7

    BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105

    FDA 510(k)
    FDA Class 2 ·Hematology

    AFFINITI TOTAL AND HEMI-SHOULDER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ZEPHYR XL DR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·January 13, 2014

    GORE EXCLUDER AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MIH·May 23, 2013

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·June 23, 2011

    PATIENT INFORMATION CENTER IX

    FDA Adverse Event
    Injury ·PHILIPS MEDICAL SYSTEMS·Product code MHX·December 4, 2023

    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