BEUDAMED
    15 results · 21ms · Sources: EU EUDAMED, US FDA

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    Easi-Vue® embolic microspheres System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Advantage ALIF Trial Cage

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215068097·

    Brisbane ALIF Cage

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215018559·

    Apollo Knotless Suture Anchor

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    T-FIX® 3DSI Joint Fusion System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523145560·R UHMWPE PS PLUS Tibial Insert Sz A 23mm

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523144259·R CIMA HXL PS PLUS Tibial Insert Sz A 23mm

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523147700·PS Plus Tibia Insert Trial Size A, 23mm - Right

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523143481·R E-CIMA Vitamin E PS PLUS Tibial Insert Sz A 23mm

    MECTALIF ANT - LAG

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code OVD·April 12, 2024

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 22, 2025

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 19, 2008

    APEX MONORAIL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code LOX·September 6, 2011

    XENFORM

    FDA Adverse Event
    Other ·TEI BIOSCIENCES INC.·Product code FTM·July 16, 2013

    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