BEUDAMED
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    RFA-7 RADIATION FIELD ANALYZER

    FDA 510(k)
    FDA Class 1 ·Radiology

    DD cubeY® HL

    FDA UDI
    Dental Direkt GmbH·EDDIG8450071·The DD cubeY® HL zirconium dioxide milling blan...

    n/a

    FDA UDI
    Hager & Meisinger Gesellschaft mit beschränkter Haftung·E0HM51008453140071·Rotary diamond instrument for dental application

    LINK Instruments - Fixation instruments

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575182572·Femoral stem prosthesis trial - Endo-Model Knee...

    SURGICAL SUCTION INSTRUMENT-REUSABLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NEISSERIA MENINGITIDIS GR. Y

    FDA 510(k)
    FDA Class 1 ·Microbiology

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 20, 2014

    TRANSMOTION MEDICAL, INC.

    FDA Adverse Event
    Other ·TRANSMOTION MEDICAL INC.·Product code GBB·November 13, 2012

    TISSUE RETRIEVAL SYSTEM ANCHOR

    FDA Adverse Event
    Injury ·Product code GCJ·September 24, 2010

    VITROS Chemistry Products LIPA Slides GEN 48, Coating 3235, REF/Catalog No. 166 8409 (60 slides per cartridge and 5 cartridges per box - 300 slides per box) and REF/Catalog No. 829 7749 (18 slides per cartridge and 5 cartridges per box - 90 slides per box). LIPA Slides are processed by higher volume (or mainframe) VITROS Chemistry Systems typically used in hospital laboratories. Ortho-Clinical Diagnostics, a Johnson & Johnson company. Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626. 510(k) #: K845027 (18 January 1985). Shelf life: Cat. # 166 8409: 12/01/07, Cat. # 829 7749: 12/01/07-1/01/08

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code CHI·October 9, 2006

    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