This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, South Korea — 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.
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 | K254232 | ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage Exclusion System (ECS140); ECLIPTIS Left Atrial Appendage Exclusion System (ECS145); ECLIPTIS Left Atrial Appendage Exclusion System (ECS150) | 2026-06-26 |
| US | K251326 | Respiration Rate algorithm | 2026-06-11 |
| US | K260105 | Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts | 2026-06-05 |
| BR | 80219050194 | Sondas de Temperatura do Injetado - CO-Set | Class I |
| BR | 80219059007 | Manípulo Universal | Class II |
| BR | 80219059008 | Manípulo para Anel de Anuloplastia | Class II |
| SA | ME0000004603SFDAA00066 | HemoSphere Pressure-Out Cable | — |
| SA | ME0000004603SFDAA00067 | Roll Stand | — |
| CA | 24580 | EDWARDS MIRA BILEAFLET PROSTHESIS | Class IV |
| CA | 20410 | STILLSITE STABILIZER | Class II |
| CA | 38673 | PRECISION-OP SYSTEM | Class II |