BEUDAMED
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    FIBER DISK AND BLOCK PERMANENT, TRINIA

    FDA 510(k)
    FDA Class 2 ·Dental

    NOVO Health Services, LLC

    FDA UDI
    NOVO HEALTH SERVICES, LLC·00812564039309·MAYO STAND COVER, 5 N/S

    Z Liquid ST B2-S 100ml

    FDA UDI
    ARGEN CORPORATION, THE·D818121735·Dental porcelain/ceramic restoration kit

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694045490·PrimaLIF LLIF PEEK Implant, 17mm X 18mm X 35mm,...

    Specials

    FDA UDI
    Seaspine Orthopedics Corporation·10889981325657·Medial Blade, Thin, 35-55mm

    PINNACLE

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295010388·PINNACLE CANCELLOUS BONE SCREW 6.5mm x 35mm

    GRIPTION

    FDA UDI
    DEPUY (IRELAND)·10603295381389·GRIPTION TF SCREW 5.5mm x 35mm

    BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2155-XXYY

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEPUY ACETABULAR

    FDA Adverse Event
    DEPUY·Product code LPH·January 25, 2013

    COYOTE? ES

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LIT·May 21, 2013

    RENASYS GO NPWT DEVICE

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW, INC.·Product code OMP·September 26, 2014

    SPRINT FIDELIS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 13, 2011

    SCEPTER XC

    FDA Adverse Event
    Malfunction ·MICROVENTION, INC.·Product code DQY·December 6, 2023

    NOVATION HIP COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·July 23, 2025

    NOVATION HIP COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·July 23, 2025

    iVue with Normative Database, Device Listing Number D185549. Product Usage: The iVue (K121739) is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional, and three dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue with Normative Database is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue with Normative Database is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population.

    FDA Enforcement
    Class II ·Terminated·Optovue, Inc.·September 6, 2017

    iVue with Normative Database, Device Listing Number D185549. Product Usage: The iVue (K121739) is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional, and three dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue with Normative Database is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue with Normative Database is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population.

    FDA Recall
    Terminated ·Optovue, Inc.·Product code HLI·July 27, 2017

    iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina and external areas of the eye to be evaluated under non-mydriatic conditions. The iCam takes digital images of the posterior and external structures of the eye without the use of a mydriatic agent and is intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health. iCam provides images only and does not provide any diagnostic, pathological analysis or classification of ocular health or disease. AND iVue with Normative Database (K121739) - The iVue is a noncontact, high resolution optical coherence tomography system intended for in vivo imaging, axial cross-sectional, three-dimensional imaging and measurement of anterior and posterior. ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue with Normative Database is a quantitative tool for comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects.

    FDA Enforcement
    Class II ·Terminated·Optovue, Inc.·September 6, 2017

    iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina and external areas of the eye to be evaluated under non-mydriatic conditions. The iCam takes digital images of the posterior and external structures of the eye without the use of a mydriatic agent and is intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health. iCam provides images only and does not provide any diagnostic, pathological analysis or classification of ocular health or disease. AND iVue with Normative Database (K121739) - The iVue is a noncontact, high resolution optical coherence tomography system intended for in vivo imaging, axial cross-sectional, three-dimensional imaging and measurement of anterior and posterior. ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue with Normative Database is a quantitative tool for comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects.

    FDA Recall
    Terminated ·Optovue, Inc.·Product code HKI·July 27, 2017