FDA applicant

Sterilab, Inc.

Carlsbad, CA1 decision1996–19960 recalls

FDA records 1 decision for Sterilab, Inc. (Carlsbad, CA) in 1996: 1 510(k) clearance. All are in product code HNY (Cystotome). 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 Sterilab, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sterilab, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Sterilab, Inc.

Which product codes does it file in?

What has FDA decided for it lately?