BEUDAMED
    8 results · 27ms · 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 ×

    THERMOPLASTIC ELASTOMER EXAMINATION (TPE) GLOVE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111354434·SPENCER WELLS FCP CVD 8"

    ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE, AG-608 SINGLE & AG-608 MULTI BLOOD GLUCOSE MONITORING SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    LAGUNA SIZE 8 PEDICLE SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 22, 2011

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 17, 2013

    PINNACLE3 RADIATION THERAPY PLANNING SYSTEM

    FDA Adverse Event
    Other ·PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.·Product code MUJ·September 13, 2008

    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