FDA applicant

Solmedix Co., Ltd.

Seoul, KR1 decision2024–20240 recalls

FDA records 1 decision for Solmedix Co., Ltd. (Seoul, KR) in 2024: 1 510(k) clearance. All are in product code SBS (Laryngeal Injection Set With Led Light). 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, ear, nose and throat panel, where it files most

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

FDA decisions per year

1in 2024

2024high 1 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Solmedix Co., Ltd. by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Solmedix Co., Ltd.

Which product codes does it file in?

What has FDA decided for it lately?