BEUDAMED
    22 results · 24ms · Sources: EU EUDAMED, US FDA

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    CONE-TROL LIQUID CHEMISTRY CONTROLS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ArgenZ ST 98x16 ML C1

    FDA UDI
    ARGEN CORPORATION, THE·D818121759·Dental porcelain/ceramic restoration kit

    UNKNOWN

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code DTK·August 14, 2015

    BELIFU

    FDA Adverse Event
    Injury ·HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED·Product code GZJ·February 10, 2020

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970379·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970423·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970393·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172974032·UniTip High Resolution Catheter 12F

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970416·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970409·

    QUANTUM RING FIXATION SYSTEM MODEL ISF

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    14F X 55CM ULTRA-FLOW CATHETER, MODELS UFS55, UFT55

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 27, 2018

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 21, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 26, 2014

    GEM MICROVASCULAR ANASTOMOTIC COUPLER

    FDA Adverse Event
    Malfunction ·SYNOVIS SURGICAL INNOVATIONS·Product code MVR·May 20, 2011

    Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

    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