510(k) Report

FDA applicant

Eagle Medical Intl.

Trophy Club, TX1 decision1994–19940 recalls

FDA records 1 decision for Eagle Medical Intl. (Trophy Club, TX) in 1994: 1 510(k) clearance. All are in product code OCT (Anti Fog Solution And Accessories, Endoscopy). No recall is linked to its devices.

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

FIG. A — Illustration, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Eagle Medical Intl. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Eagle Medical Intl.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Eagle”

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