BEUDAMED
    13 results · 22ms · Sources: EU EUDAMED, US FDA

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    Cryon-X Cold Compression

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690197096·Revision Knee Spiral Reamer- Hudson Short Flute...

    PINN CUP IMPACTOR TIP 32MM

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code HWA·January 30, 2026

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668101261·SWISS MODEL BLADE BREAKER

    ARTICUL/EZE

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295129172·ARTICUL/EZE TRIAL HEAD 36mm -2

    Truliant

    FDA UDI
    Exactech, Inc.·10885862556332·TRIAL, TIBIAL INSERT, CR, NEUTRAL, SIZE 5

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·October 8, 2003

    AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000

    FDA 510(k)
    FDA Class 2 ·Immunology

    Cool-tip RF Ablation System E Series

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

    SPROTTE

    FDA Adverse Event
    Other ·PAJUNK GMBH MEDIZINTECHNOLOGIE·Product code BSP·August 23, 2011

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·December 5, 2008

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·July 29, 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