This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, 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 | K261085 | Rapid Vessel Occlusion (Rapid VO) | 2026-07-13 |
| US | K251987 | Rapid Aortic Measurements | 2025-09-23 |
| US | K251533 | Rapid Obstructive Hydrocephalus, Rapid OH | 2025-09-04 |
| BR | 80117580754 | Rapid | Class II |