FDA applicant

American Biomaterials Corp.

The Woodlands, TX6 decisions1985–19940 recalls

FDA records 6 decisions for American Biomaterials Corp. (The Woodlands, TX) from 1985 to 1994: 6 510(k) clearances. Most are in product codes DQO (Catheter, Intravascular, Diagnostic) and LRS (I.V. Start Kit). 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 hospital panel, where it files most

How often FDA has decided American Biomaterials Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for American Biomaterials Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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American Biomaterials Corp.

Which product codes does it file in?

What has FDA decided for it lately?