This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 9 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 | K251357 | Esperance pHLO Aspiration System | 2026-01-15 |
| US | K242676 | pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device | 2025-02-28 |
| US | K242420 | pNOVUS 21 Microcatheter | 2024-11-12 |