BEUDAMED
    7 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.
    Filters Regulation: Us FDA ×

    MEDICATOR AEROSOL DRUG DELIVERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    RF LESION CANNULA, RF THERMOLESION CANNULA, THERMOLESION CANNULA, X-RAY CONTRAST CANNULA, CANNULA, FACET DENERATION NEED

    FDA 510(k)
    FDA Class 2 ·Neurology

    HEARTSTREAM FR2

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·January 25, 2013

    INOMAX DS (DELIVERY SYSTEM)

    FDA Adverse Event
    Malfunction ·INO THERAPEUTICS, LLC/IKARIA·Product code MRN·December 16, 2010

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·July 17, 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