This company has registrations in United States, Brazil, Canada, Israel — 4 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 | K141869 | QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT | 2014-10-10 |
| US | K032127 | HEMEDEX FIXATION DEVICE | 2003-12-30 |
| US | K032337 | HEMEDEX CRANIAL BOLT MODELS, 3601, 3602 | 2003-10-21 |
| CA | 90326 | QFLOW 500 TITANIUM BOLT SINGLE LUMEN | Class II |
| CA | 90327 | QFLOW 500 CRANIAL DRILL BITS | Class II |
| CA | 90328 | QFLOW 500 TITANIUM BOLT DUAL LUMEN | Class II |