This company has registrations in United States, Brazil, Canada, Singapore, South Korea, Australia, Hong Kong, Israel — 8 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 | K193268 | APrioCore Plus | 2020-02-27 |
| US | K181756 | Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle | 2018-12-18 |
| US | K150625 | Morrison Steerable Needle | 2015-06-09 |
| BR | 10289680138 | Cânula para biópsia óssea Bonopty® | Class II |
| BR | 10289680139 | Cânula para penetração óssea Bonopty® | Class II |
| BR | 10289680187 | Cânula flexível dirigível radiopaca ecogênica para injeção por punção | Class II |