BEUDAMED
    12 results · 26ms · Sources: EU EUDAMED, US FDA

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    MICRO ELECTRODES

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Brigade

    FDA UDI
    Nuvasive, Inc.·00887517402912·Brigade Implant, 18x38x32mm 12°

    TiLock2 Spinal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NEOSS VARIOUS TITANIUM ABUTMENTS

    FDA 510(k)
    FDA Class 2 ·Dental

    B1005, ACUCISE ENDOPYELOTOMY SYSTEM

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL RESOURCES·Product code EYB·April 17, 2017

    SMOOTH MOD HIGH BOOST, 775 CC

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·December 18, 2024

    XENIUM XPM

    FDA Adverse Event
    Malfunction ·NIPRO CORPORATION *USD*·Product code KDI·February 21, 2013

    COAGUCHEK® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·January 27, 2011

    TAN 130 NAILS

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JDS·July 31, 2014

    Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film sterilizable outer pouch.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 8, 2017

    Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025

    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