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

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    EUROIMMUN Anti-West Nile Virus ELISA (IgM)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517566539·CoRoent Ant TLIF PEEK, 15x13x30mm 8°

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690129004·Revision Tibia Augment Peg Bolt Size 8mm

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111049156·SKLHN SKLT METZ SCISS STR 8"

    AGC KNEE SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304221932·

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100301·INFANT WIRE SPECULUM 3MM/5MM BLADES

    AIDA HD CONNECT WITH SMARTSCREEN / BLU-RAY DRIVE / SMARTSCREEN WITH BLU-RAY DRIVE

    FDA 510(k)
    FDA Class 2 ·Radiology

    ABX MICROS CRP 200, OPTION IM

    FDA 510(k)
    FDA Class 2 ·Hematology

    GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 3 RIGHT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 27, 2017

    BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code FPA·April 26, 2024

    BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code FPA·April 15, 2024

    FUSION NAVIGATION SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·June 8, 2013

    MEMBRAGEL

    FDA Adverse Event
    Injury ·INSTITUT STRAUMANN AG·Product code NPK·June 30, 2011

    WALLSTENT RX BILIARY ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC·Product code FGE·September 5, 2008

    BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·March 18, 2019

    ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    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