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    RTVUE MODEL RTVUE 100

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.

    FDA Enforcement
    Class II ·Terminated·Optovue Inc.·October 31, 2012

    Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.

    FDA Recall
    Terminated ·Optovue Inc.·Product code OBO·September 7, 2012

    18M - Loggers - 18 Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588015057·18M - Loggers - 18 Metal

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383501309·Gutta Percha Points is used to root canal filin...

    Tasso+

    FDA UDI
    Tasso Inc.·00860006434595·

    FO NX Nail System

    FDA UDI
    FIELD ORTHOPAEDICS PTY LTD·09353903012573·1.0 Double-ended Trocar K-wire 150 mm 5/pkg

    Instrument

    FDA UDI
    BICON, LLC·00813110029539·Thin Crestal Abutment Removal Tool

    ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT

    FDA 510(k)
    FDA Class 2 ·Dental

    IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS), IMMULITE 2000 INTACT PTH, MODEL L2KPP (200 TESTS), L2K6

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    15" LONG HANDLE REVERSE ANGLED CURETTE

    FDA Adverse Event
    Injury ·LIFE INSTRUMENTS·Product code HTF·January 29, 2025

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M93071015052C0·Custom Curette #5 Reverse Angle

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M93071015050ST0·Toothed Curette #5 Str 7" handle

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M93071015051TC0·Custom 15" Curette #5 w/teeth, Angled

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M93071015054S0·15" Long Curette #5 Left 7" handle

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M93071015054T0·Toothed Long Handle Curette #5 Ang Lft

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M93071015051SC0·Curette 15" 5" Handle 10" WL # 5 Angled

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M93071015050SC0·Curette 15" Length 5" Handle 10 Wl

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M93071015052TC0·Custom 15" Curette #5 w/teeth, Rev. Angle

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M93071015050T0·Toothed Long Handle Curette #5 Str