BEUDAMED
    12 results · 28ms · Sources: EU EUDAMED, US FDA

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    T2 XVBR SPINAL SYSTEM, T2 ALTITUDE EXPANDABLE CORPECTOMY DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Oticon

    FDA UDI
    Oticon A/S·05707131259356·NERA, KIT 312 OMNI R BE

    SCENARIA WHOLE-BODY X-RAY CT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION TO CD HORIZON SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TEXIUM

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS S.A DE C.V.·Product code FMF·March 19, 2026

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·Product code KWP·November 2, 2021

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·Product code KWP·November 2, 2021

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·Product code KWP·November 2, 2021

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code JJE·May 29, 2013

    SPRINT

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code LWS·June 16, 2011

    DUROM US ACETABAR COMPONENT 50/44 J

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·August 18, 2008

    Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No

    FDA Enforcement
    Class I ·Ongoing·Edwards Lifesciences, LLC·July 16, 2025