BEUDAMED
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    LANCER L-INA ANTI-C3

    FDA 510(k)
    FDA Class 2 ·Immunology

    Novo Surgical Inc.

    FDA UDI
    NOVO SURGICAL, INC.·00842331145391·seldin periosteal elevator no. 23, flat handle,...

    IVUE, MODEL 100

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    NUVA-FIL COMPOSITE RESTORATIVE (MODI.)

    FDA 510(k)
    FDA Class 2 ·Dental

    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

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·May 5, 2014

    CARELINK

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code KRG·October 15, 2012

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 22, 2015

    PROPONENT DR SL (Model L201)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025