63 results
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62ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS100 Model/Catalog Number: VS100 Software Version: Software version 3.2.0.1 Product Description: Welch Allyn Spot Vision Screener VS100, FDA product code name: Refractometer, ophthalmic One unit per package
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·March 25, 2026
ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR
FDA Enforcement
Class II
·Terminated·Johnson & Johnson Vision Care, Inc.·April 4, 2018
FULL VISION INC. TRACKMASTER,TREADMILL TMX428 220V, Model #317-07927
FDA Enforcement
Class II
·Ongoing·Full Vision Inc·December 14, 2022
FULL VISION INC. TRACKMASTER, TREADMILL TMX428CP 110V, Model #317-07928
FDA Enforcement
Class II
·Ongoing·Full Vision Inc·December 14, 2022
FULL VISION INC. TRACKMASTER, TREADMILL TMX428 110V, Model #317-07926
FDA Enforcement
Class II
·Ongoing·Full Vision Inc·December 14, 2022
FULL VISION INC. TRACKMASTER, TREADMILL TMX428CP 220V, Model #317-07929
FDA Enforcement
Class II
·Ongoing·Full Vision Inc·December 14, 2022
FULL VISION INC. TRACKMASTER, TREADMILL GE T2100-ST1 110V, Model #317-07926GE
FDA Enforcement
Class II
·Ongoing·Full Vision Inc·December 14, 2022
FULL VISION INC. TRACKMASTER, TREADMILL GE T2100-ST2 220V, Model #317-07927GE
FDA Enforcement
Class II
·Ongoing·Full Vision Inc·December 14, 2022
FULL VISION INC. TRACKMASTER, TREADMILL GE T2100-ST2 220V, Model #317-07927GE CHINA
FDA Enforcement
Class II
·Ongoing·Full Vision Inc·December 14, 2022
Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, Inc.
FDA Enforcement
Class I
·Terminated·RVO 2.0, INC·March 13, 2019
1-DAY ACUVUE Moist for ASTIGMATISM Brand Contact Lenses
FDA Enforcement
Class II
·Terminated·Johnson & Johnson Vision Care, Inc.·April 4, 2018
Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Product #8065751079, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.
FDA Enforcement
Class II
·Terminated·Alcon Research LLC·April 29, 2020
TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System.
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·March 12, 2014
Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.9.2; Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities
FDA Enforcement
Class II
·Terminated·Sensus Healthcare, Inc.·March 15, 2023
Ziehm Vision system, x-ray, tomography, computed.
FDA Enforcement
Class II
·Ongoing·Orthoscan, Inc.·December 11, 2024
Ziehm Vision R. Iterventional fluoroscopic x-ray system
FDA Enforcement
Class II
·Ongoing·Orthoscan, Inc.·December 11, 2024
Ziehm Vision FD. Interventional fluoroscopic x-ray system
FDA Enforcement
Class II
·Ongoing·Orthoscan, Inc.·December 11, 2024
Ziehm Vision RFD. Interventional fluoroscopic x-ray system
FDA Enforcement
Class II
·Ongoing·Orthoscan, Inc.·December 11, 2024
Ziehm Vision RFD 3D. Interventinoal fluoroscopic x-ray system
FDA Enforcement
Class II
·Ongoing·Orthoscan, Inc.·December 11, 2024
Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Combined Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Surgical procedure pack to interface with Alcon Constellation Surgical console. Component: N/A
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·July 16, 2025