This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Israel, Russia — 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 | K140679 | SUREFLEX LITHOTRIPSY LASER FIBERS | 2014-06-20 |
| US | K131229 | SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS | 2013-12-05 |
| US | K132655 | RETROARC RETROPUBIC SLING SYSTEM | 2013-11-20 |
| BR | 10341350886 | KIT ACESSÓRIO PARA O SISTEMA DE CONTROLE URINÁRIO AMS 800 | Class II |
| BR | 10341350891 | KIT ACESSORIO AMS 700 | Class II |
| CA | 68857 | CONTINUUM | Class II |
| CA | 74883 | SMART SLING SYSTEM | Class III |
| CA | 93563 | RETROARC RETROPUBIC SLING SYSTEM | Class III |