This company has registrations in United States, Brazil, Saudi Arabia, Canada, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 overseas markets. The China NMPA lookup is still pending.
Australia, Hong Kong, Saudi Arabia, Singapore, Israel: under each source's terms, this site shows record counts and official links only — no record details on pages, in search, in the member area or in exports.
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 | K253159 | Prophecy Incompass Surgical Planning System | 2026-06-16 |
| US | K251643 | Synchfix EVT | 2025-10-29 |
| US | K252085 | Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom) | 2025-09-30 |
| BR | 80005439064 | KIT INSTRUMENTAL PROSTEP MIS COM LÂMINA | Class II |
| BR | 80005430718 | Instrumentais para o Sistema DART-FIRE | Class II |
| BR | 80005430719 | INSTRUMENTAIS PRO-TOE® | Class I |
| CA | 15836 | OSTEOSET DBM PELLETS | Class IV |
| CA | 38684 | MIIG, MINIMALLY INVASIVE INJECTABLE GRAFT | Class III |
| CA | 70988 | 5TH METATARSAL FRACTURE SCREW | Class III |
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