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 | K130487 | FASTRESPONDER STERNAL INTRAOSSEOUS DEVICE | 2013-06-25 |
| US | K100124 | FASTX STERNAL INTRAOSSEOUS DEVICE | 2010-08-31 |
| US | K080865 | FAST1 INTRAOSSEOUS INFUSION SYSTEM | 2008-04-24 |
| BR | 80921099002 | T-PODResponderTM | Class I |
| BR | 80921099003 | MATResponderTM Tourniquet | Class I |
| BR | 80921090001 | FAST Sternal Intraosseous Device | Class II |
| CA | 79891 | CRIC CRICOTHYROIDOTOMY SYSTEM | Class II |
| CA | 81857 | FASTX STERNAL INTRAOSSEOUS DEVICE | Class II |