This company has registrations in United States — 1 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 | K991898 | ULTRA-SELECT GUIDEWIRE, HYTEK GUIDEWIRE | 1999-06-16 |
| US | K991194 | MODIFICATION TO ULTRA-SELECT GUIDEWIRE | 1999-05-05 |
| US | K982657 | AMPLATZ THROMBECTOMY DEVICE MODELS ATD 601, ATD 602, ATD 801, ATD 802, FOOT PEDAL ASSEMBLY MODEL AK 100 | 1998-11-18 |