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    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

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

    The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table, X-ray generator, and cleared wireless digital detectors. The list of detectors verified and validated for use with the Discovery XR656 HD system, including their specifications, are provided in the user documentation. The System generates diagnostic The components may be combined in different configurations to meet specific customer needs. In addition, upgrade configurations are available for predicate devices. The optional image pasting function enables the operator to stitch sequentially acquired radiographs into a single image. This 510(k) is to incorporate the VolumeRad advanced application that was currently available on the Discovery XR656 product onto the Discovery XR656 HD, as well as introduce a new Metal Artifact Reduction Algorithm, and an optional standalone console to take any HelixTM acquired images via DICOM (such as from a Discovery XR656 HD, Optima XR646 HD, or Optima XR240amx) and process the images independently of the system it was acquired on.

    FDA Recall
    Open, Classified ·GE Hangwei Medical Systems, Co. LTD West Area Bldg. 3, No.1 Yongchang North Road 1 Yongchangbeilu; Beijing Economic and Technological Development Area Beijing China·Product code KPR·November 7, 2023

    The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table, X-ray generator, and cleared wireless digital detectors. The list of detectors verified and validated for use with the Discovery XR656 HD system, including their specifications, are provided in the user documentation. The System generates diagnostic The components may be combined in different configurations to meet specific customer needs. In addition, upgrade configurations are available for predicate devices. The optional image pasting function enables the operator to stitch sequentially acquired radiographs into a single image. This 510(k) is to incorporate the VolumeRad advanced application that was currently available on the Discovery XR656 product onto the Discovery XR656 HD, as well as introduce a new Metal Artifact Reduction Algorithm, and an optional standalone console to take any HelixTM acquired images via DICOM (such as from a Discovery XR656 HD, Optima XR646 HD, or Optima XR240amx) and process the images independently of the system it was acquired on.

    FDA Recall
    Open, Classified ·GE Hangwei Medical Systems, Co. LTD West Area Bldg. 3, No.1 Yongchang North Road 1 Yongchangbeilu; Beijing Economic and Technological Development Area Beijing China·Product code KPR·November 7, 2023

    Various types of Fetal Bovine Serum Bovine sourced Animal Sera for in-vitro diagnostic device and as a growth promoting nutrient in cell culture systems.

    FDA Recall
    Terminated ·Paa Laboratories Inc 145 Bethridge Road Etobicoke Canada Ontario·Product code KIS·April 12, 2013

    Fancy i Color cosmetic lens, Contents: A pair of sterile soft color contact lens immersed in buffered isotonic saline solution, Size: B.C. 8.6mm DIA. 14.5mm. Dreamcon Co. LTD. Korea.

    FDA Recall
    Terminated ·Kim's Trading Inc·Product code LPM·May 17, 2010

    Product is a ChoICE 182 cm Guide Wire, intended to facilitate placement of balloon dilatation catheters and other therapeutic devices during Percutaneous Transluminal Coronary Angioplasty (PTCA) procedures. The ChoICE guide wire contains a one-piece stainless steel core, which extends throughout the length of the wire and provides steerability and torqueability. The wire is tapered and formed at the distal tip. A radiopaque platinum spring coil surrounds the distal tip of the core wire. The ChoICE Guide Wire is a single use, sterile (EO), device packaged in a carrier tube, which is held in a coil by plastic clips. The carrier tube assembly of the guide wire is sealed into a pouch. One side of the pouch is clear polyethylene/polyester laminate and the reverse side is Tyvek. The pouch assemblies are packaged in a five-pack product box. A flushing tool is included in the package to facilitate hydration of the coating with heparanized saline before use. 1, page 1, is a copy of the pouch label. Exhibit 1, page 2 is a copy of the five-pack product box label. Exhibit 2 is a copy of the Directions for Use.

    FDA Recall
    Terminated ·Symbiosis Corp.·Product code DQX·November 19, 2002

    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 Recall
    Terminated ·Quidel Corporation·Product code PSZ·December 15, 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 Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JIT·January 5, 2017

    SYNCHRON Systems Modular Creatinine (CREm) Reagent Kit, Part Number: 472525 Systems AQUA CAL 1 and 2, is intended for the quantitative determination of creatinine concentration in human serum, plasma or urine. CREm reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 800 System and SYNCHRON Systems AQUA CAL 1 and 2, is intended for the quantitative determination of creatinine concentration in human serum, plasma or urine.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CGX·August 2, 2010

    Coulter PrepPlus 2 (part # 378600) is a microprocessor-controlled pipetting and diluting system. PrepPlus 2 is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples. The PrepPlus 2 is a compact, fully automated sample work station which can be programmed to perform a wide variety of liquid handling operations where volumes required range from 5 uL to 1000 uL.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code JQW·January 18, 2011

    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 Recall
    Terminated ·Churchill Medical Systems, Inc.·Product code FPA·August 12, 2013

    Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter Product Code: CD-10802 GTN: 00801902015396

    FDA Recall
    Terminated ·Arrow International Inc·Product code DQY·January 10, 2019

    GE Healthcare Voluson E8 ultrasound scanner with Software version 6.2.0 and 6.2.1 and DICOM stations with these software versions; GE Healthcare 9900 West Innovation Drive, Wauwatosa, WI 53226, USA.

    FDA Recall
    Terminated ·Ge Healthcare·Product code IYO·July 6, 2007

    Arrow Two-Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter Product Code: AH-11802 (OUS) GTN: 00801902026132

    FDA Recall
    Terminated ·Arrow International Inc·Product code DQY·January 10, 2019

    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 Recall
    Terminated ·Roche Diagnostics Corporation·Product code CZP·June 3, 2019

    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 Recall
    Terminated ·bioMerieux, Inc.·Product code LON·March 15, 2019

    FDP Plasma kit provides reagents for the detection and semi-quantitation of fibrin/fibrinogen degradation products (FDP) in plasma through the use of latex particles coated with monoclonal antibodies to FDP. The kit contains: 1 x1.3 mL vial of Reagent 1 (Latex), 1 x 20mL bottle of Reagent 2 (Buffer), 1 x 0.5mL vial of Reagent 3 (Negative Control), 1 x 0.5mL vial of Reagent 4 (Positive Control) and 10 test cards with mixing rods packaged in a predominantly white cardboard unit container. Distributed in the USA by Diagnostica Stago, Five Century Drive, Parsippany, NJ 07054.

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code DAP·December 4, 2002

    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 Recall
    Terminated ·Sekisui Diagnostics Llc·Product code GGP·October 24, 2012