84 results
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35ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR
FDA Enforcement
Class II
·Terminated·Johnson & Johnson Vision Care, Inc.·April 4, 2018
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
Product is a lithium ion battery sold as both a stand-alone accessory, and as part of endoscopy system sets. Stand alone labeling: Vision Sciences Rechargeable Lithium Ion Batteries, Replacement (2) [REF] 07-3052; [MFG Symbol] Vision-Sciences, Inc., 40 Ramland Road South, Orangeburg, NY 10962 USA. Accessory to endoscopy kits used to charge/recharge lithium ion batteries.
FDA Recall
Terminated
·Vision-Sciences, Inc.·Product code EOB·December 27, 2011
Product is a lithium ion battery charger sold as both a stand-alone accessory, and as part of endoscopy system sets. --- Stand alone labeling: Vision Sciences Battery Charger, Lithium Ion [REF] 07-3051; [MFG Symbol] Vision-Sciences, Inc., 40 Ramland Road South, Orangeburg, NY 10962 USA. Accessory to endoscopy kits used to charge/recharge lithium ion batteries.
FDA Recall
Terminated
·Vision-Sciences, Inc.·Product code EOB·December 27, 2011
Varian Medical Systems, Inc. Eclipse/VARiS Vision, an Eclipse radiotherapy Treatment Planning System (Eclipse TPS); Eclipse Version 7.3.10 (multiple workstations) VARiS Vision System 7. x; Model Numbers: H48/H83.
FDA Recall
Terminated
·Varian Medical Systems Oncology Systems·Product code MUJ·May 13, 2010
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
Intuitive brand da Vinci S Surgical System, Endoscopic Instrument Control System, Model IS1200 with Isolation Transformer (P/N: 952012) and Vision Cart (Model VS1000), Distributed and Manufactured by: Intuitive Surgical, Inc. 950 Kifer Road Sunnyvale, CA
FDA Recall
Terminated
·Intuitive Surgical, Inc.·Product code NAY·October 4, 2007
Intuitive brand da Vinci S Surgical System, Endoscopic Instrument Control System, Model IS2000 with Isolation Transformer (P/N: 952012) and Vision Cart (Model: VS2000), Distributed and Manufactured by: Intuitive Surgical, Inc. 950 Kifer Road Sunnyvale, CA
FDA Recall
Terminated
·Intuitive Surgical, Inc.·Product code NAY·October 4, 2007
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
Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, Inc.
FDA Recall
Terminated
·RVO 2.0, INC·Product code LQE·November 13, 2018
Continuous ventilator accessories under the following brand names: a) RP-Seal, Spring-5 pk model number F35465; b) RP-Seal, Greece, Ballscrew model number F35036; c) RP-Tub PVC 1/8 in x 50 ft model number 1008841; d) RP-Vision Filter Cover model number 1003444; e) RP-Vision RS-232 HRN ABV 106K model number 1004699; and f) RP-Wrap, Cord model number F35195. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
FDA Recall
Terminated
·Respironics, Inc.·Product code CBK·October 15, 2007
The Enfant Evoked Response Photic Stimulator. The Enfant A Pediatric Vision Testing Device, Manufactured by Diopsys, Inc., 355 Main St., Metuchen, NJ 08840. Each medical device unit is assembled and contains an 18 inch flat panel vision stimulator panel, a 17 inch flat panel operator monitor, a 2.25 inch thermal printer, a mobile point of care cart, medical grade battery back-up, speaker, a CPU with floppy and CD drives, a camera and an isolation transformer.
FDA Recall
Terminated
·Diopsys Inc·Product code GWE·September 15, 2004
Diopsys Inc., Enfant Pediatric VEP Vision Testing System, Input: 120 Vac, 60Hz/2.5A IEC 60601-1 Class I, Type BF.
FDA Recall
Terminated
·Diopsys, Inc.·Product code GWE·April 2, 2007
Site Rite Vision Ultrasound System, REF 9770032, Bard Access Systems, Inc. Intended for diagnostic ultrasound imaging or fluid flow analysis of the human body.
FDA Recall
Terminated
·Bard Access Systems·Product code IYN·June 21, 2011
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 Recall
Terminated
·Sensus Healthcare, Inc.·Product code JAD·February 10, 2023
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 Recall
Terminated
·Alcon Research LLC·Product code HQC·July 25, 2018
ACUVUE OASYS for ASTIGMATISM Brand Contact Lenses. Lot no. B00NKM0G. Base Curve 8.6, Refractive Power -3.00D-1.25/90.
FDA Recall
Terminated
·Johnson & Johnson Vision Care, Inc.·Product code MVN·December 18, 2017
TECNIS Symfony Extended Range of Vision IOL, Model No. ZXR00 The product is indicated primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction, and aphakia following refractive lensectomy in presbyopic adults, who desire useful vision over a continuous range of distances including far, intermediate and near, and increased spectacle independence. The lens is intended to be placed in the capsular bag.
FDA Recall
Terminated
·Abbott Medical Optics Inc. (AMO)·Product code HQL·August 26, 2016