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Product Classification / EMDN Category

FDA Product Code: FXN

Directory of devices assigned to product classification code FXN.

classification Tape, Camera, Surgical Manufacturer:

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gudid Dr.meter Manufacturer: Shenzhen Urion Technology Co., Ltd

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gudid The SnapshotGLO is a portable, non-invasive optical imaging device designed to capture wound images under visible and fluorescence lighting. It combines a multispectral light source (including LEDs and a low-power laser) with a specialized camera to help healthcare professionals visualize and document wound characteristics such as size, shape, and fluorescence indicating bacterial contamination. The system includes embedded software for image capture, display, and storage, with an intuitive interface for point-of-care use. Manufacturer: Kent Imaging Inc

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gudid Tissue Analytics Manufacturer: Net Health Systems, Inc.

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gudid The Minuteful for Wound device is a comprehensive wound management system designed to assist in the management of chronic wounds. It is intended to support healthcare professionals in the clinical assessment of wounds by measuring, documenting, monitoring, and managing information relevant to the progression and treatment of chronic wounds. The device comprises Calibration Stickers, a Web Portal for healthcare professionals to review and manage wound data, and two separate smartphone applications. These applications are utilized for the collection of wound data: one for healthcare professionals and one for lay users under the guidance and supervision of healthcare professionals. Manufacturer: HEALTHY.IO LTD

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gudid The Minuteful for Wound device is a comprehensive wound management system designed to assist in the management of chronic wounds. It is intended to support healthcare professionals in the clinical assessment of wounds by measuring, documenting, monitoring, and managing information relevant to the progression and treatment of chronic wounds. The device comprises Calibration Stickers, a Web Portal for healthcare professionals to review and manage wound data, and two separate smartphone applications. These applications are utilized for the collection of wound data: one for healthcare professionals and one for lay users under the guidance and supervision of healthcare professionals. Manufacturer: HEALTHY.IO LTD

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gudid The Minuteful for Wound device is intended to provide healthcare professionals with a tool to document, track, and monitor chronic wounds which will aid in wound care management. Manufacturer: HEALTHY.IO LTD

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gudid The SPOT device is intended to provide healthcare professionals with a tool to document, track, and monitor chronic wounds which will aid in wound care management. Manufacturer: HEALTHY.IO LTD

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gudid The SPOT device is intended to provide healthcare professionals with a tool to document, track, and monitor chronic wounds which will aid in wound care management. Manufacturer: HEALTHY.IO LTD

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gudid For use when the Thermal Imaging Module is attached. (Required with 2517 MolecuLightDX Eco DarkDrapes) Manufacturer: MolecuLight Inc

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gudid Adds thermal imaging capabilities to the MolecuLightDX+ device to quantify skin temperature changes at the point-of-care. Manufacturer: MolecuLight Inc

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gudid SilhouetteStar is a non-contact device used to collect images, measurements and other information from all external wound types at the point of care; it is connected to a computer via a USB cable. Manufacturer: ARANZ MEDICAL LIMITED

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gudid Automated Wound Measurements Manufacturer: EPIC SYSTEMS CORPORATION

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gudid System for wound measurement and management. Manufacturer: E-Kare Inc.

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gudid The PACS Scan Mobile client is an application for mobile devices that can used to easily capture images and videos and send them to patient studies on DICOM archives. The user queries and retrieves a patient study from a worklist, or creates a new patient record. The user may then take clinical photos and/or videos to send to the patient record. Photos may be manipulated (crop and rotate) and annotated prior to sending. Videos may not be altered prior to sending. Unwanted images may be deleted prior to sending. The user may also add a series description to the study. Typical users of the PACS Scan Mobile application are trained medical professionals, including but not limited to clinicians, technologists, assistants and lay persons. PSM is not intended for diagnostic use. Manufacturer: HYLAND LLC

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gudid Swift Vision Manufacturer: Swift Medical Inc

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gudid Medline NE1 WMS Manufacturer: Swift Medical Inc

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gudid Healogics Photo+ Manufacturer: Swift Medical Inc

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gudid PointClickCare Skin and Wound Manufacturer: Swift Medical Inc

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gudid Swift Skin and Wound Manufacturer: Swift Medical Inc

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