BEUDAMED
    68 results · 20ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Enforcement × Status: Terminated × Clear all

    iVue 500 with iScan, D216606. Product 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 500 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 500 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 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 Enforcement
    Class II ·Terminated·Optovue, Inc.·September 6, 2017

    VITROS Chemistry Products FS Calibrator 1, REF 680 1873 12 x 3 mL, Rx ONLY, IVD; used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate VITROS 5,1 FS/4600 Chemistry and integrated Systems. --- Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626 --- Ortho-Clinical Diagnostics Pencoed, CF35 5PZ, UK ---- Background: VITROS assays must be calibrated prior to use in order to be used to produce assay results. The Assay Data Disk (ADD) contains calibrator assigned values/ calculation data for multiple VITROS Calibrators and Lots. The Data Release Version (DRV) number identifies the version of the ADD. Each time the ADD is updated with new ata, the DRV number increments higher. The DRV with the highest number contains the most current data. The VITROS 4600 and 5,1 FS Chemistry Systems and the VITROS 5600 Integrated System are the only VITROS Systems that run the assays that are associated with VITROS Chemistry Products FS Calibrator 1. VITROS FS Calibrator 1 is required to calibrate VITROS RF, dLDL, hsCRP, AMPH, BARB, BENZ, COCM, CP, ASO, THC, d%A1c assays. VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate the VITROS 5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. VITROS FS Calibrator 1 is used on VITROS Systems to calibrate the following assays: VITROS AMPH, ASO, BARB, BENZ, COCM, d%A1c, dLDL, hsCRP, PCP, RF and THC Reagents

    FDA Enforcement
    Class III ·Terminated·Ortho-Clinical Diagnostics·February 15, 2017

    Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer intended to be used with Cassette-based immunofluorescent in vitro diagnostic assays . Sofia 2 is intended for professional and laboratory use.

    FDA Enforcement
    Class II ·Terminated·Quidel Corporation·April 4, 2018

    Vygon 14 Microbore Extension Set with Bionector, CMS-814-1. The CMS-814-1 is a 14 inch extension set used to administer IV fluids.

    FDA Enforcement
    Class II ·Terminated·Churchill Medical Systems, Inc.·September 25, 2013

    The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies react with antigen in the sample to form an antigen/antibody complex which is measured turbidimetrically.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·July 24, 2019

    BIOTRONIK INTICA NEO 7 HF-T DF-1 IS-1 ProMRI, REF 429553, UDI: 04035479156831 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.

    FDA Enforcement
    Class II ·Terminated·BIOTRONIK Inc·April 28, 2021

    Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quantitative determination of Plasminogen Activator Inhibitor Type 1 in human plasma. Catalog # 101201. Spectrolyse PAI-1 is intended for the quantitative determination of Plasminogen Activator Inhibitor Type-1 (PAI-1) activity in human plasma. The test is for in vitro diagnostic use.

    FDA Enforcement
    Class II ·Terminated·Sekisui Diagnostics Llc·December 12, 2012

    Biomerieux Vitek 2 Test kit VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.

    FDA Enforcement
    Class II ·Terminated·bioMerieux, Inc.·April 24, 2019

    VITROS Chemistry Products Calibrator Kit 2, manufactured by Ortho Clinical Diagnostics 1000 Lee Road Rochester, NY 14606 VITROS Chemistry Products Calibrator Kit 2 is used to calibrate VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of CHOL, Cl-, ECO2, K+, Na+, and TRIG.

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·March 5, 2014

    ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 The device is intended for use in conjunction with certain materials to measure a variety of analytes.

    FDA Enforcement
    Class II ·Terminated·Horiba Instruments, Inc dba Horiba Medical·July 4, 2018

    Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic for the determination of direct bilirubin SMN: 11097532 - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma on the ADVIA¿ Chemistry systems. Such measurements are useful in the screening of liver function disorders or in the diagnosis of jaundice.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·April 1, 2020

    VITEK 2 card AST-N371 - Product Usage: The VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth-based biochemical patterns to determine identification. The VITEK 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria.

    FDA Enforcement
    Class II ·Terminated·bioMerieux, Inc.·April 1, 2020

    Concerto User Interface Software provided with the following systems: (1) Xstrahl 100 Electronic Brachytherapy - 100kV Superficial X-Ray Therapy System; (2) Xstrahl 150 Electronic Brachytherapy - 150kV Superficial X-Ray Therapy System; (3) Xstrahl 200 - 225kV Superficial / Orthovoltage X-Ray Therapy System; (4) Xstrahl 300 - 300kV Orthovoltage X-Ray Therapy System; (5) Xstrahl X 80 Photoelectric Therapy System.

    FDA Enforcement
    Class II ·Terminated·Xstrahl Limited·November 3, 2021

    VITEK 2 60 computer system when equipped with the following Hewlett-Packard PC models: (1) rp5700, Cat. #W0452; (2) rp5700 (refurbished), Cat. #W0452R; (3) rp5800 XPE, Cat. 413642; (4) rp5800 WES7, Cat. #413862; (5) dc7100 8-port, Cat. #W0441; (6) dc7100 8-port (refurbished), Cat. #W0441R; (7) dc7700 8-port, Cat. #W0447; (8) dc7700 8-port (refurbished), Cat. #W0447R; (9) dc7800, Cat. #W0449; and (10) dc7800 (refurbished), Cat. #W0449R. VITEK 2 is an automated system designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.

    FDA Enforcement
    Class II ·Terminated·Biomerieux Inc·April 3, 2013

    VITEK 2 XL computer system when equipped with the following Hewlett-Packard PC models: (1) rp5700, Cat. #W0452; (2) rp5700 (refurbished), Cat. #W0452R; (3) rp5800 XPE, Cat. 413642; (4) rp5800 WES7, Cat. #413862; (5) dc7100 8-port, Cat. #W0441; (6) dc7100 8-port (refurbished), Cat. #W0441R; (7) dc7700 8-port, Cat. #W0447; (8) dc7700 8-port (refurbished), Cat. #W0447R; (9) dc7800, Cat. #W0449; and (10) dc7800 (refurbished), Cat. #W0449R. VITEK 2 is an automated system designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.

    FDA Enforcement
    Class II ·Terminated·Biomerieux Inc·April 3, 2013

    VITROS (R) Chemistry Products FS Calibrator 1, Product Code/ Catalog Number 6801873 -- For in vitro diagnostic use only --- VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate the VITROS 5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·June 25, 2014

    100/120V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·June 3, 2015

    Base for Terumo Advanced Perfusion System 1, 220/240V The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·June 3, 2015