510(k) Report

FDA applicant

Brown Medical Industries

Spirit Lake, IA1 decision1997–19970 recalls

FDA records 1 decision for Brown Medical Industries (Spirit Lake, IA) in 1997: 1 510(k) clearance. All are in product code EFQ (Gauze/Sponge, Internal). 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 Brown Medical Industries’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Brown Medical Industries since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Brown Medical Industries’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 “Brown”

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