FDA applicant

Optima Health Solutions International, Inc.

Vancouver, CA3 decisions2006–20190 recalls

FDA records 3 decisions for Optima Health Solutions International, Inc. (Vancouver, CA) from 2006 to 2019: 3 510(k) clearances. All are in product code LXM (Manipulator, Plunger-Like Joint). Its devices cite 3 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Optima Health Solutions International Corp.”, “Optima Health Solutions International Corporation”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

How often FDA has decided Optima Health Solutions International, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2007high 1 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Optima Health Solutions International…’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 “Optima”

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

Optima Neuroscience, Inc. 2

Optima Health Solutions International, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Optima”