FDA applicant

Orthomerica Products, Inc.

Orlando, FL21 decisions2000–20240 recalls

FDA records 21 decisions for Orthomerica Products, Inc. (Orlando, FL) from 2000 to 2024: 21 510(k) clearances. Most are in product codes OAN (Orthosis, Cranial, Laser Scan) and MVA (Orthosis, Cranial). Its devices cite 27 predicates, 22 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, neurology panel, where it files most

How often FDA has decided Orthomerica Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2007high 3 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Orthomerica Products, 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?