BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    2D Hip Planning Software

    FDA 510(k)
    FDA Class 2 ·Radiology

    XiVE®

    FDA UDI
    Dentsply Implants Manufacturing GmbH·07392532223952·Depth Stop anterior D4.5+5.5/L11

    Integra® Miltex®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780425724·Integra® Miltex® Love Nerve Root Retractor, 7-1...

    LONG NAIL KIT R2.0, STST, RIGHT 11X360MM X 125

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·May 25, 2010

    3D Auto LAA

    FDA 510(k)
    FDA Class 2 ·Radiology

    PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM FOR THE UPPER EXTREMITY

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ATLAS PLUS VR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL INC., CRMD·Product code LWS·January 11, 2014

    ACCU-CHEK ® AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·September 23, 2011

    SIGN IM NAIL

    FDA Adverse Event
    Injury ·SIGN FRACTURE CARE INTERNATIONAL·Product code HSB·July 23, 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