FDA applicant

Sofregen Medical, Inc.

Medford, MA3 decisions2017–20240 recalls

FDA records 3 decisions for Sofregen Medical, Inc. (Medford, MA) from 2017 to 2024: 3 510(k) clearances. Most are in product codes MIX (System, Vocal Cord Medialization) and OXF (Mesh, Surgical, Absorbable, Plastic And…). Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Sofregen Medical”.

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

FIG. A — Illustration, ear, nose and throat panel, where it files most

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

FDA decisions per year

1in 2024

2017high 1 (2017) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Sofregen Medical, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Sofregen Medical, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?