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

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    Cerafix Dura Substitute

    FDA 510(k)
    FDA Class 2 ·Neurology

    INERTIA PEDICLE SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OPTYSE OPHTHALMOSCOPE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    UNKNOWN

    FDA Adverse Event
    Injury ·COOK INC·Product code DTK·February 19, 2019

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013

    FINELINE II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·July 13, 2011

    HAKIM INLINE PROGRAMMABLE VALVE SG

    FDA Adverse Event
    Injury ·CODMAN & SHURTLEFF, INC./MEDOS S.A.·Product code JXG·September 15, 2008

    DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

    FDA Adverse Event
    Injury ·COOK INC·Product code DTK·February 19, 2019

    UNKNOWN

    FDA Adverse Event
    Injury ·COOK INC·Product code DTK·February 19, 2019

    UNKNOWN

    FDA Adverse Event
    Injury ·COOK INC·Product code DTK·February 19, 2019

    UNKNOWN

    FDA Adverse Event
    Injury ·COOK INC·Product code DTK·March 23, 2018

    ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    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