FDA applicant

Secured Ortho Manufacturing of America, LLC

Deer Park, NY1 decision2021–20210 recalls

FDA records 1 decision for Secured Ortho Manufacturing of America, LLC (Deer Park, NY) in 2021: 1 510(k) clearance. All are in product code FXX (Mask, Surgical). 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, general and plastic surgery panel, where it files most

How often FDA has decided Secured Ortho Manufacturing of America, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Secured Ortho Manufacturing of America, LLC by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Secured Ortho Manufacturing of America, LLC

Which product codes does it file in?

What has FDA decided for it lately?