BEUDAMED
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    LED Light Therapy Machine (G1, G3, G4, G6)

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

    NA

    FDA UDI
    Medos International Sàrl·10886705030248·Laparoscope, High Definition Eye Piece style 5....

    RADIANCE PORCELAIN

    FDA 510(k)
    FDA Class 2 ·Dental

    ProFlex Laser Fibers (ProFlex 200) and ProFlex Laser Fibers (PRoFlex 273)

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

    ARTICUL/EZE ZIR BALL 28+8.5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LZO·November 20, 2008

    UNICEL® DXC 600I SYNCHRON® ACCESS CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·September 10, 2011

    GRANUFLOW

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 19, 2013

    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