BEUDAMED
    9 results · 21ms · 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.

    OP-CON SURG. INSTRUMENT #7

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    ULTRA PULSATOR

    FDA 510(k)

    ULTRAKIT

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL UM-D·Product code FPA·January 3, 2025

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 27, 2014

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·November 15, 2012

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·June 10, 2015

    INSET

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·June 7, 2024

    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