This company has registrations in United States, Canada, Singapore, Australia, Hong Kong, Israel — 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.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| US | K242480 | FLASH EVD System (10-0002) | 2024-12-27 |
| US | K220522 | 7D Surgical System - Percutaneous Application (7D Flash Frame) | 2022-05-20 |
| US | K210457 | 7D Registration Frame, 7D Flex Iliac Pin Connector, 7D Pin Guide Block, 7D 3.2 mm Steinmann Pin, 7D Iliac Crest Pin Chuck & Key | 2021-06-21 |