FDA applicant

Revmedx, Inc.

Wilsonville,, OR7 decisions2014–20250 recalls

FDA records 7 decisions for Revmedx, Inc. (Wilsonville,, OR) from 2014 to 2025: 6 510(k) clearances and 1 De Novo grant. All are in product code PGZ (Non-Absorbable, Expandable, Hemostatic Sponge…). Its devices cite 7 predicates, 7 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2025

2014high 1 (2014) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Revmedx, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Revmedx, Inc.

Which product codes does it file in?

Which of its devices are cited most?

What has FDA decided for it lately?