This company has registrations in United States, Israel — 2 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 | K091310 | ABLATION INSTRUMENT, MODEL 1635; ABLATION MULTIPLEX CATHETER, MODEL 1682 | 2010-08-11 |
| US | K090986 | STABILI ERX BONE CEMENT, MODEL 1135,STABILIT VERTEBRAL AUGMENTATION SYSTEM (FOR USE W/ STABILIT ERX BONE CEMENT) | 2009-12-30 |
| US | K072496 | MODIFICATION TO SPACE CPSXL BONE CEMENT | 2007-10-05 |