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

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    VAC-G (GUILLOTINE VITRECTOR)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Archon

    FDA UDI
    Nuvasive, Inc.·00887517311290·Archon Screw, 4.5x19mm S.T. Fixed

    K-FLEX

    FDA 510(k)

    EMI SIMULATOR REMOTE CONTROL CONSOLE

    FDA 510(k)
    FDA Class 2 ·Radiology

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 18, 2014

    RADIAL JAW 4 BIOPSY FORCEPS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - COSTA RICA·Product code FCL·October 25, 2010

    MARATHON MICRO CATHETER

    FDA Adverse Event
    Malfunction ·EV3 NEUROVASCULAR·Product code DYG·December 20, 2012

    Radial Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.

    FDA Enforcement
    Class I ·Terminated·Cook Inc.·March 2, 2016

    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