510(k) Report

FDA applicant

Eagle Medical, Inc.

Bridgeton, MO3 decisions1989–19930 recalls

FDA records 3 decisions for Eagle Medical, Inc. (Bridgeton, MO) from 1989 to 1993: 3 510(k) clearances. Most are in product codes NAB (Gauze / Sponge,Nonresorbable For External Use) and LYY (Latex Patient Examination Glove). 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Eagle Medical, Inc.’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.