This company has registrations in United States, Brazil, Canada — 3 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 | K823894 | MODEL RZ PACEMAKER LEAD VARIOUS | 1983-04-30 |
| US | K823896 | MODEL FF..D & FX..D PACEMAKER LEADS | 1983-04-30 |
| US | K823892 | MODEL SZ PACEMAKER LEAD-VARIOUS | 1983-04-30 |
| BR | 80152120022 | CATETER BALÃO OSYPKA | Class II |
| CA | 10301 | CERABLATE-P STEERABLE RF ABLATION AND MAPPING CATHETER | Class IV |
| CA | 10281 | SINGLE PASS VDD LEAD - QUADRIPOLAR MODEL VDD | Class IV |
| CA | 10285 | FINDER DIAGNOSTIC E.P. CATHETER | Class IV |