BEUDAMED
    8 results · 17ms · 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.

    SPIRIT

    FDA 510(k)
    FDA Class 2 ·Dental

    SDU 800 DIAGNOSTIC ULTRASOUND INSTRUMENT

    FDA 510(k)
    FDA Class 2 ·Radiology

    TECHNICON RA SYSTEMS TOBRAMYCIN TEST METHOD

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    OPTUNE GIO

    FDA Adverse Event
    Injury ·NOVOCURE GMBH·Product code NZK·August 14, 2025

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES·Product code LZG·May 22, 2014

    PRODISC-L REVISIONS

    FDA Adverse Event
    Injury ·SYNTHES·Product code MJO·January 4, 2013

    ECHELON 45

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·November 11, 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