FDA applicant

Optomed Oyj

Oulu, FI1 decision2020–20200 recalls

FDA records 1 decision for Optomed Oyj (Oulu, FI) in 2020: 1 510(k) clearance. All are in product code HKI (Camera, Ophthalmic, Ac-Powered). Its devices cite 2 predicates, 0 of them its own earlier devices. 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 Optomed Oyj’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Optomed Oyj by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Optomed Oyj’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Optomed”

FDA records each applicant name separately; these may or may not be the same firm.

Optomed OY 7

Optomed Oyj

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Optomed”