BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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    ShapeIT (SI014135)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Acetabular reamer ø68mm

    FDA UDI
    Incipio Devices SA·07630055301703·Acetabular reamer for hip arthroplasty

    TALOS®-A

    FDA UDI
    SpineArt SA·07640375238146·TALOS®-A (HA) PEEK PLANAR, ASYMMETRIC IBFD D26 ...

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B167312416110·

    TALOS® HA PEEK IBF

    FDA UDI
    MEDITECH SPINE, LLC·B167322416110·

    LYTHOS DIGITAL IMPRESSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP

    FDA 510(k)
    FDA Class 2 ·Neurology

    COVER, BURR HOLE

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code GXR·July 1, 2016

    NOVOFINE 6MM (31G)

    FDA Adverse Event
    Injury ·NOVO NORDISK A/S, MEDICAL SYSTEMS·Product code FMI·November 20, 2008

    ADJ PIN COLLET 2.0 - 3.2 MM

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·September 2, 2011

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·July 22, 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