This company has registrations in United States, Canada, Taiwan, Australia, Hong Kong, Israel — 6 overseas markets. The China NMPA lookup is still pending.
Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.
Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| US | K250910 | Optilume® High Pressure Urological Balloon Dilation Catheter | 2025-05-22 |
| US | K191061 | Optilume Basic Urological Balloon Dilation Catheter | 2020-01-02 |