FDA applicant

Bio Nuclear Diagnostics, Inc.

Toronto, Ontario, CA1 decision2008–20080 recalls

FDA records 1 decision for Bio Nuclear Diagnostics, Inc. (Toronto, Ontario, CA) in 2008: 1 510(k) clearance. All are in product code HHT (Spatula, Cervical, Cytological). 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 Bio Nuclear Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Bio Nuclear Diagnostics, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Bio Nuclear Diagnostics, Inc.

Which product codes does it file in?

What has FDA decided for it lately?