FDA applicant

Rejoni, Inc.

Bedford, MA2 decisions2022–20260 recalls

FDA records 2 decisions for Rejoni, Inc. (Bedford, MA) from 2022 to 2026: 1 510(k) clearance and 1 original PMA approval. Most are in product codes LKF (Cannula, Manipulator/Injector, Uterine) and MCN (Barrier, Absorbable, Adhesion). Its devices cite 1 predicate, 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

1in 2022

2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Rejoni, Inc. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Rejoni, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?