This company has registrations in United States, Brazil, Canada, South Korea, Australia, Hong Kong — 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 | K251007 | CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F) | 2025-05-01 |
| US | K243954 | PeriCross Epicardial Access Kit | 2025-04-24 |
| US | K243193 | Cross Wise Multi-Use RF Adapter Cable | 2024-11-26 |
| BR | 80102519093 | SISTEMA DE MONITORAMENTO DE TEMPERATURA CIRCA | Class II |
| BR | 80267039011 | SONDA ESOFÁGICA CIRCA 3D - S-CATH M | Class II |
| CA | 93933 | CIRCA S-CATH ESOPHAGEAL TEMPERATURE MONITORING SYSTEM | Class II |