FDA applicant
Vision-Sciences, Inc.
FDA records 33 decisions for Vision-Sciences, Inc. (Natick, MA) from 1986 to 2011: 33 510(k) clearances. Most are in product codes EOB (Nasopharyngoscope (Flexible Or Rigid)) and FAM (Sigmoidoscope And Accessories, Flexible/Rigid). Its devices cite 68 predicates, 59 of them its own earlier devices. 2 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Vision-Sciences, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2011
2026 so far, outlined.
Recalls per year
2in 2011
Class I Class II/III not classified
Planning a device like Vision-Sciences, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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