This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel — 8 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 | K232148 | X-Guide Surgical Navigation System | 2024-02-21 |
| US | K211701 | X-Guide® Surgical Navigation System | 2022-02-01 |
| US | K200662 | X-Guide® Surgical Navigation System | 2020-05-21 |
| BR | 10064019041 | X - Guide | Class II |