BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    BrainPort V100

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    VOYAGER LINUX WITH TACTILE GUIDANCE SYSTEM (TGS)

    FDA 510(k)
    FDA Class 2 ·Neurology

    NOFACT VIII

    FDA 510(k)
    FDA Class 2 ·Hematology

    WALLSTENT RP ENDOPROSTHESIS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MAF·April 19, 2023

    NONE - SEE PHYSICIAN COMMENTS IN H10.

    FDA Adverse Event
    Injury ·Product code JWH·October 16, 2013

    ATTAIN ABILITY

    FDA Adverse Event
    Injury ·RICE CREEK MFG·Product code OJX·June 8, 2013

    X8000 LIGHTSOURCE

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY SAN JOSE·Product code FCW·June 28, 2011

    PRECISION XTRA/OPTIUM

    FDA Adverse Event
    Injury ·ABBOTT DIABETES CARE INC.·Product code NBW·September 5, 2008

    WALLSTENT? RP ENDOPROSTHESIS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·July 21, 2025

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

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

    Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025