Insight Instruments, Inc.
Insight Instruments, Inc. holds FDA 510(k) medical device clearance, cleared in 2005, with 2 FDA device recalls on record.
Top product codes for Insight Instruments, Inc.
FDA recalls by Insight Instruments, Inc.
- Z-0144-2014 — MLS Torpedo Mini-Light Ophthalmic single-port illumination. Sutureless 25- gauge illuminator for vitreo-retinal surgery when full field illumination of bimanual surgery if desired.
- Z-1281-2013 — Insight Instruments MIS ( Multi-Port Illumination System) Illuminated pilot tubes work like a ceiling light while simultaneously protecting the entry sites. Illumination automatically follows the movement of the two surgical instruments inserted into the M.I.S. cannulas. The large distance of more than 16mm between cannula ends and posterior pole guarantees sufficient light in the working area and a large observation field especially when used in conjunction with modern wide field panoramic observation systems.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Insight Instruments, Inc.
Data sourced from openFDA. This site is unofficial and independent of the FDA.