BEUDAMED
    17 results · 22ms · Sources: EU EUDAMED, US FDA

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    SLIT LAMPS WITH SL CAM 5.0 DIGITAL IMAGING SOLUTION

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    AGXO

    FDA UDI
    Oticon A/S·05707131261373·H110, BTE 13 WL 85 STG AGXO

    BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACTIV.A.C.¿ THERAPY SYSTEM

    FDA Adverse Event
    Injury ·KINETIC CONCEPTS, INC.·Product code OMP·February 12, 2018

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    KENSTONE METAL·Product code ITJ·May 29, 2013

    CRYSTALENS

    FDA Adverse Event
    Injury ·BAUSCH + LOMB·Product code NAA·June 15, 2011

    WALLFLEX BILIARY RX UNCOVERED STENT SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·August 22, 2008

    ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM

    FDA Adverse Event
    Injury ·KINETIC CONCEPTS, INC.·Product code OMP·June 8, 2021

    ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM

    FDA Adverse Event
    Injury ·KINETIC CONCEPTS, INC.·Product code OMP·July 14, 2021

    1.55MM X 10MM FLUTED TWIST DRL

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBE·October 17, 2016

    1.55MM X 10MM FLUTED TWIST DRL

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBE·October 17, 2016

    FUJIFILM

    FDA Adverse Event
    Death ·FUJIFILM TECHNO PRODUCTS CO., LTD. MITO SITE·Product code FDF·July 22, 2016

    FUJIFILM

    FDA Adverse Event
    Death ·FUJIFILM TECHNO PRODUCTS CO., LTD.·Product code FCX·July 22, 2016

    FUJIFILM

    FDA Adverse Event
    Death ·FUJIFILM TECHNO PRODUCTS CO., LTD. MITO SITE·Product code FDS·July 22, 2016

    Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; 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 Biplane; Catalog numbers: (1) 722008, (2) 722013.

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