FDA applicant

Brooke Intl.

Pasadena, CA1 decision1990–19900 recalls

FDA records 1 decision for Brooke Intl. (Pasadena, CA) in 1990: 1 510(k) clearance. All are in product code HHI (System, Abortion, Vacuum). 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 Brooke Intl.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Brooke Intl. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Brooke Intl.

Which product codes does it file in?

What has FDA decided for it lately?