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 | K240915 | ZIEN IO Intraosseous Access System | 2024-07-02 |
| US | K214060 | LANDMARK REBOA Catheter | 2022-09-19 |
| BR | 10212990354 | ASPIRADOR PARA TROMBECTOMIA | Class I |
| BR | 10212999015 | Conjunto de cateter para trombectomia de 60 e 90 cm | Class II |
| BR | 10212999016 | Conjunto de cateter aspirador troca rápida para trombectomia | Class II |
| CA | 95026 | PENBLADE DISPOSABLE SAFETY SCALPEL | Class II |
| CA | 96657 | ASPIRATOR SYRINGE | Class II |