FDA applicant

Onli

Gahanna, OH1 decision1995–19950 recalls

FDA records 1 decision for Onli (Gahanna, OH) in 1995: 1 510(k) clearance. All are in product code HGE (Amniotome). 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 Onli’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Onli since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Onli

Which product codes does it file in?

What has FDA decided for it lately?