510(k) Report

FDA applicant

Osmunda Medical Device Consulting Co., Ltd.

Guangzhou, Guangdong, CN1 decision2014–20140 recalls

FDA records 1 decision for Osmunda Medical Device Consulting Co., Ltd. (Guangzhou, Guangdong, CN) in 2014: 1 510(k) clearance. All are in product code LNS (Lithotriptor, Extracorporeal Shock-Wave…). 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, gastroenterology and urology panel, where it files most

How often FDA has decided Osmunda Medical Device Consulting Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2014: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Osmunda Medical Device Consulting Co., Ltd. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LNSLithotriptor, Extracorporeal Shock-Wave, Urological1decision

What has FDA decided for it lately?

  • K131817Extracorporeal Shock Wave LithotripterOsmunda Medical Device Consulting Co., Ltd. · 2014

The one decision as Osmunda Medical Device Consulting Co., Ltd. →