This company has registrations in United States, Brazil, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 8 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 | K220654 | ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire | 2022-04-06 |
| US | K212977 | SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands | 2022-02-17 |
| US | K210626 | SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter | 2021-04-23 |
| BR | 81356119003 | KIT INTRODUTOR RADIAL RAIN MINI FIO-GUIA NITINOL | Class II |
| BR | 81356119004 | KIT INTRODUTOR RADIAL RAIN MINI FIO-GUIA POLÍMERO | Class II |
| BR | 81576629007 | Guia Introdutor Vista Brite Tip IG Hockey Stick | Class II |