BEUDAMED
    9 results · 24ms · Sources: EU EUDAMED, US FDA

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    LASERSAFE EYE SHIELDS

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    Gauthier Biomedical

    FDA UDI
    GAUTHIER BIOMEDICAL, INC.·00858325005770·MINI INLINE HANDLE, RATCHETING

    DENALI DEFORMITY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Hi-Torque Command 18 Guide Wire

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 5, 2014

    RADIOFREQUENCY PROBE KIT

    FDA Adverse Event
    Malfunction ·BAYLIS MEDICAL CO., INC.·Product code GXI·November 13, 2012

    ACRYSOF IQ TORIC

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LTD / HUNTINGTON·Product code HQL·September 28, 2010

    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

    Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025