This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, 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 | K253580 | Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S) | 2026-04-26 |
| US | K231691 | Phantom XL Insulated Dilators | 2023-06-29 |
| US | K161318 | Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems | 2017-03-20 |
| BR | 80978563786 | Instrumentais para Cirurgia de Coluna II | Class I |
| BR | 10355870366 | INSTRUMENTOS CIRÚRGICOS TSI COPOLÍMEROS | Class I |
| BR | 80444810108 | Phantom AL Sistema Retrator de Acesso Anterior | Class I |
| SA | ME0000000653SFDAA00033 | CT LIFT SYSTEM | — |
| SA | ME0000000653SFDAA00034 | ULTRA VISION | — |
| CA | 98064 | DISTRACTION SCREWS, STANDARD AND QUICK START (NON-STERILE) | Class II |