This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 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 | K260480 | VELYS Robotic-Assisted Solution | 2026-06-25 |
| US | K261458 | ATTUNE Total Knee System; ATTUNE Cementless Knee System | 2026-06-25 |
| US | K260536 | Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement | 2026-05-15 |
| BR | 10132590285 | INSTRUMENTOS P.F.C* E SPECIALIST* | Class I |
| BR | 80145901861 | Instrumentais Actis | Class I |
| BR | 10132590627 | KIT INSTRUMENTAL PARA PROTESE MODULAR DE QUADRILC-STEM* | Class I |
| SA | ME0000003221SFDAA00028 | SIG HP BASE FEMUR & TIBIA CASE | — |
| CA | 78618 | SURGICAL GLOVE LINERS | Class II |