FDA applicant

Quality Synthetics Intl, Inc.

Garden Grove, CA4 decisions1988–19900 recalls

FDA records 4 decisions for Quality Synthetics Intl, Inc. (Garden Grove, CA) from 1988 to 1990: 4 510(k) clearances. All are in product code HIS (Condom). 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 Quality Synthetics Intl, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Quality Synthetics Intl, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Quality Synthetics Intl, Inc.

Which product codes does it file in?

What has FDA decided for it lately?