FDA applicant

Hardcover Products, Inc.

Concord, Ontario, CA2 decisions1999–19990 recalls

FDA records 2 decisions for Hardcover Products, Inc. (Concord, Ontario, CA) in 1999: 2 510(k) clearances. Most are in product codes HIS (Condom) and LTZ (Condom With Nonoxynol-9). 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Hardcover Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hardcover Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Hardcover Products, Inc.

Which product codes does it file in?

What has FDA decided for it lately?