This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Israel — 7 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 | K240137 | Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System | 2024-02-16 |
| US | K221795 | STERN FIX Sternal Stabilization System | 2022-10-19 |
| US | K211613 | Stern Fix Sternal Stabilization System | 2022-01-19 |
| BR | 80015970037 | Medidor de profundidade | Class I |
| BR | 80015970038 | Alicate | Class I |
| BR | 80015970039 | Retrator | Class I |