510(k) Report

FDA applicant

Eagle Vision, Inc.

Bethesda, MD7 decisions1988–20060 recalls

FDA records 7 decisions for Eagle Vision, Inc. (Bethesda, MD) from 1988 to 2006: 7 510(k) clearances. Most are in product codes LZU (Plug, Punctum) and OKS (Lacrimal Stents And Intubation Sets). Its devices cite 12 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

How often FDA has decided Eagle Vision, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Eagle Vision, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Eagle Vision, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Eagle Vision, 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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Other applicant names beginning “Eagle”

FDA records each applicant name separately; these may or may not be the same firm.