BEUDAMED
    9 results · 18ms · 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.

    CALL-RAD PC TELERADIOLOGY

    FDA 510(k)
    FDA Class 2 ·Radiology

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704289794·

    B1018 POROUS HA BII-PORE

    FDA 510(k)
    FDA Class 2 ·Dental

    MENS-O-MATIC 1XS AND MENS-O-MATIC 2XS

    FDA 510(k)
    FDA Class 2 ·Neurology

    STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F/4.0MM INTRODUCER SYSTEM

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - CORK·Product code DTK·May 14, 2013

    IN TOUCH ZX

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·February 15, 2013

    LINE SET FOR AQUARIUS

    FDA Adverse Event
    Malfunction ·HAEMOTRONICS SPA·Product code FJK·January 19, 2011

    OPTI-FIX

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JDH·July 29, 2014

    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