This company has registrations in United States, Canada, Australia, Israel — 4 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 | K254277 | Embrace Neonatal MRI System | 2026-03-13 |
| US | K170978 | Embrace Neonatal MRI System | 2017-07-19 |
| US | K160185 | Wrist 3 | 2016-03-01 |