FDA applicant

Miracell Co., Ltd.

Seoul, KR2 decisions2026–20260 recalls

FDA records 2 decisions for Miracell Co., Ltd. (Seoul, KR) in 2026: 2 510(k) clearances. All are in product code QBV (Centrifuge For Preparation Of Cell Concentrate…). 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, clinical chemistry panel, where it files most

How often FDA has decided Miracell Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2026

2026high 2 (2026)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2026.

FIG. 1 — Miracell Co., Ltd. by year, 2026–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Miracell Co., Ltd.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?