BEUDAMED
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    ETI-EA-G ASSAY

    FDA 510(k)
    FDA Class 1 ·Microbiology

    SeraQuest

    FDA UDI
    QUEST INTERNATIONAL, INC.·00850487007524·Epstein-Barr virus (EBV) early antigen (EA) imm...

    IJS

    FDA UDI
    SKELETAL DYNAMICS L.L.C.·00841506105154·IJS-E K-Wire Guide, 1.5mm

    IJS

    FDA UDI
    SKELETAL DYNAMICS L.L.C.·00841506132907·IJS Axis Trajectory Guide, Rotated, Small, Left

    IJS

    FDA UDI
    SKELETAL DYNAMICS L.L.C.·00841506132891·IJS Axis Trajectory Guide, Rotated, Small, Right

    IJS

    FDA UDI
    SKELETAL DYNAMICS L.L.C.·00841506105161·IJS-E Axis Guide, Lateral Approach, Lg

    IJS

    FDA UDI
    SKELETAL DYNAMICS L.L.C.·00841506105185·IJS-E Axis Guide, Lateral Approach, Sm

    IJS

    FDA UDI
    SKELETAL DYNAMICS L.L.C.·00841506132921·IJS Axis Trajectory Guide, Rotated, Medium, Left

    IJS

    FDA UDI
    SKELETAL DYNAMICS L.L.C.·00841506132914·IJS Axis Trajectory Guide, Rotated, Medium, Right

    IJS

    FDA UDI
    SKELETAL DYNAMICS L.L.C.·00841506132938·IJS Axis Trajectory Guide, Rotated, Large, Right

    IJS

    FDA UDI
    SKELETAL DYNAMICS L.L.C.·00841506132945·IJS Axis Trajectory Guide, Rotated, Large, Left

    IJS

    FDA UDI
    SKELETAL DYNAMICS L.L.C.·00841506105178·IJS-E Axis Guide, Lateral Approach, Md

    SENSAR IOL

    FDA Adverse Event
    Malfunction ·AMO PUERTO RICO MFG. INC.·Product code HQL·July 15, 2021

    TECNIS IOL

    FDA Adverse Event
    Malfunction ·AMO PUERTO RICO MFG. INC.·Product code HQL·August 11, 2022

    TECNIS SIMPLICITY

    FDA Adverse Event
    Malfunction ·AMO PUERTO RICO MFG. INC.·Product code HQL·September 27, 2021

    SMARTLOAD

    FDA Adverse Event
    Malfunction ·AMO PUERTO RICO MFG. INC.·Product code HQL·July 12, 2022

    TECNIS IOL

    FDA Adverse Event
    Malfunction ·AMO MANUFACTURING NETHERLANDS·Product code POE·July 23, 2021

    TECNIS SIMPLICITY

    FDA Adverse Event
    Malfunction ·AMO PUERTO RICO MFG. INC.·Product code HQL·September 27, 2021

    TECNIS IOL

    FDA Adverse Event
    Malfunction ·AMO PUERTO RICO MFG. INC.·Product code HQL·January 9, 2024

    VITAN

    FDA Adverse Event
    Malfunction ·DUCKWORTH & KENT·Product code MSS·March 23, 2024