BEUDAMED
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    OXYGEN CONNECTOR AND OXYGEN DELIVERY TUBING

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    ReLine

    FDA UDI
    Nuvasive, Inc.·00195377035097·RELINE-C Screwdriver, Stab and Grab

    Trimline

    FDA UDI
    ORMCO CORPORATION·00889989052473·LOWER LEFT SECOND MOLAR TRIMLINE BAND SIZE 11

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690196518·AK3 Tibial Cutting Block - Left

    N/A

    FDA UDI
    Ulrich GmbH & Co. KG·04052536083459·uCentum instrument tray 1 open and percutaneous...

    uCentum

    FDA UDI
    Ulrich GmbH & Co. KG·04052536220298·Layer 1.1 for uCentum instruments, open and per...

    uCentum

    FDA UDI
    Ulrich GmbH & Co. KG·04052536220304·Layer 1.2 for uCentum instruments, open and per...

    Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STIMULATOR, MENTOR 100 NERVE

    FDA 510(k)
    FDA Class 2 ·Neurology

    VerSys®

    FDA UDI
    Zimmer, Inc.·00889024140165·

    VerSys®

    FDA UDI
    Zimmer, Inc.·00889024140158·

    VerSys®

    FDA UDI
    Zimmer, Inc.·00889024453357·

    ACUITY

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code OJX·November 3, 2010

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 7, 2014

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·December 28, 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

    TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·May 20, 2015