FDA applicant

Brandwynne Corp.

Los Angeles, CA1 decision1997–19970 recalls

FDA records 1 decision for Brandwynne Corp. (Los Angeles, CA) in 1997: 1 510(k) clearance. 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 Brandwynne Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Brandwynne Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Brandwynne Corp.’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

Brandwynne Corp.

Which product codes does it file in?

What has FDA decided for it lately?