FDA applicant

Moerae Matrix, Inc.

North Brunswick, NJ2 decisions2014–20140 recalls

FDA records 2 decisions for Moerae Matrix, Inc. (North Brunswick, NJ) in 2014: 1 510(k) clearance and 1 De Novo grant. Most are in product codes PDW (Internal Tissue Marker) and GBX (Catheter, Irrigation). 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

2in 2014

2014high 2 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

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

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Moerae Matrix, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?