FDA applicant

American Fluoroseal Corp.

Silver Spring, MD2 decisions1987–19940 recalls

FDA records 2 decisions for American Fluoroseal Corp. (Silver Spring, MD) from 1987 to 1994: 2 510(k) clearances. All are in product code KJA (Flask, Tissue Culture). 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, hematology panel, where it files most

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

FDA decisions per year

No FDA decision for American Fluoroseal Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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American Fluoroseal Corp.

Which product codes does it file in?

What has FDA decided for it lately?