BEUDAMED
    8 results · 22ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    PEMACO 2000 INTRAORAL DENTAL WAX

    FDA 510(k)
    FDA Class 1 ·Dental

    InterChange Blade

    FDA UDI
    KOROS U.S.A., INC.·10840199538567·InterChange Blade 62mm

    PATIENT EXAMINATION GLOVES (LATEX)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SPQ(TM) ANTIBODY REAGENT SET II FOR HPT

    FDA 510(k)
    FDA Class 2 ·Immunology

    LOCK-CAP F/URS

    FDA Adverse Event
    Injury ·SYNTHES MEZZOVICO·Product code NKB·June 25, 2014

    LIPOSONIX

    FDA Adverse Event
    Injury ·SOLTA MEDICAL, INC.·Product code OHV·January 3, 2013

    RIATA PASSIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·November 10, 2010

    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