FDA applicant

Bova Intl.

Fort Worth, TX2 decisions1994–19950 recalls

FDA records 2 decisions for Bova Intl. (Fort Worth, TX) from 1994 to 1995: 2 510(k) clearances. Most are in product codes KYB (Lens, Guide, Intraocular) and HIW (Anomaloscope). 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, ophthalmic panel, where it files most

How often FDA has decided Bova Intl.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bova Intl. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Bova Intl.’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

Bova Intl.

Which product codes does it file in?

What has FDA decided for it lately?