510(k) Report

FDA applicant

Tri-Med Specialties, Inc.

Overland Park, KS14 decisions1985–19970 recalls

FDA records 14 decisions for Tri-Med Specialties, Inc. (Overland Park, KS) from 1985 to 1997: 14 510(k) clearances. Most are in product codes LRO (General Surgery Tray) and KDH (Catheter (Gastric, Colonic, Etc.), Irrigation…). 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 Tri-Med Specialties, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Tri-Med Specialties, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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