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

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    RadiForce MX243W

    FDA 510(k)
    FDA Class 2 ·Radiology

    BD BBL™ Sabouraud Dextrose Agar Mycoflask™

    FDA UDI
    BECTON, DICKINSON AND COMPANY·30382902211366·Mycoflask Sabouraud Dextrose Ag 10 Ea

    RENOIR POSTERIOR CERVIAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TEKNIQUE-HOVEROUND POWER WHEEL CHAIR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Widex

    FDA UDI
    Widex A/S·05706069810035·Widex EVOKE E-FS (Deep Blue ) 220, Telecoil, RC...

    CATALYFT¿ PL EXPANDABLE INTERBODY SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code MAX·January 29, 2025

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·November 3, 2014

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·August 23, 2011

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·July 11, 2013

    CATALYFT¿ PL EXPANDABLE INTERBODY SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code MAX·September 30, 2024

    LAPIPLASTY SYSTEM S4A

    FDA Adverse Event
    Injury ·TREACE MEDICAL CONCEPTS, INC.·Product code HRS·March 14, 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