This company has registrations in United States, Australia — 2 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 | K260223 | Aristotle Mini Guidewire | 2026-08-06 |
| US | K260002 | Socrates Aspiration System (Socrates 70 Aspiration Catheter) | 2026-07-16 |
| US | K253579 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire | 2026-04-29 |