FDA applicant

Houston Biomedical, Inc.

Houston, TX3 decisions1986–19870 recalls

FDA records 3 decisions for Houston Biomedical, Inc. (Houston, TX) from 1986 to 1987: 3 510(k) clearances. Most are in product codes FGE (Stents, Drains And Dilators For The Biliary…) and KOD (Catheter, Urological). 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 Houston Biomedical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Houston Biomedical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Houston Biomedical, 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 “Houston”

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

Houston Medical Robotics 1

Houston Biomedical, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Houston”