This company has registrations in United States, Canada, Taiwan, Singapore, 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 | K181290 | Fusion Bx 2.0 | 2018-06-15 |
| US | K153166 | Fusion Bx | 2016-01-25 |
| CA | 98933 | FUSION BX 1.1 | Class II |
| CA | 100503 | FUSION MR PRO | Class II |
| CA | 101798 | FUSION BX/MR PRO | Class II |