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    Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300, Arvis Surgical Planning Software Software Version: V2025.1.2 Product Description: Intended Use: The ARVIS" system is a computer-controlled navigation system intended to provide intra-operative measurements to the surgeon to aid in selection and positioning of orthopedic implant components. Description: ARVIS Shoulder is a computer-controlled surgical navigation system for shoulder arthroplasty. It aids the surgeon in making intra-operative measurements and locating anatomical structures of the shoulder joint based on the patient s preoperative imaging to assist with selection and positioning of orthopedic implant components. The system consists of software, electronic hardware and surgical instruments. The device s workflow involves CT based preoperative planning followed by intraoperative navigation and execution. The preoperative planning software enables 3D virtual implant positioning based on the patient s CT reconstructed digital bone model and bony landmarks. The shoulder navigation application software then matches the patient s digital bone model and landmarks to the intraoperative landmarks registered by the surgeon, allowing an image-based navigation to follow. The surgeon uses the plan data as guidance to navigate and help position shoulder instruments and implants.

    FDA Recall
    Open, Classified ·Kico Knee Innovation Company·Product code SBF·September 19, 2025

    Color contact lenses labeled under the following brands: Diamond, Fierce, Ambition, Circle Collection, Lunatic, Fright, Desire and See Clear.

    FDA Recall
    Open, Classified ·The See Clear Company·Product code LPL·January 6, 2017

    Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)

    FDA Recall
    Open, Classified ·Visgeneer, Inc. No. 335 Zhong Hua Rd., Sec. 6 Xiangshan Dist. Hsinchu City Taiwan·Product code PTC·October 4, 2023

    Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)

    FDA Recall
    Open, Classified ·Visgeneer, Inc. No. 335 Zhong Hua Rd., Sec. 6 Xiangshan Dist. Hsinchu City Taiwan·Product code PTC·October 4, 2023