This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Israel, Russia — 7 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.
Business registration data from SEC EDGAR, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| US | K253473 | Synchrony | 2026-04-01 |
| US | K251792 | Stereotaxis GenesisX RMN with Navigant Workstation (NWS) | 2025-11-06 |
| US | K250590 | MAGiC Sweep EP Mapping Catheter | 2025-07-23 |
| BR | 80421720006 | CARDIODRIVE® SISTEMA DE AVANÇO DE CATETERES DESCARTÁVEL | Class II |
| CA | 69660 | ENDOVASCULAR GUIDEWIRES | Class II |