This company has registrations in United States, Brazil, Saudi Arabia, Canada — 4 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 | K260649 | OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr. (WA2C19BO); Obturator, 21 Fr. (WA2C21BO); Obturator, 21 Fr., for sheath with ramp (WA2C21RO); Obturator, 21 Fr., long (WA2C21LO); Obturator, 21 Fr., for straight sheath (WA2C21SO); Obturator, 22.5 Fr. (WA2C22BO); Obturator, 25 Fr. (WA2C25BO); Obturator, optical, 19.8 Fr. (WA2C19BV); Obturator, optical, 21 Fr. (WA2C21BV); Obturator, optical, 21 Fr., for straight sheath (WA2C21SV); Obturator, optical, | 2026-05-21 |
| US | K252043 | Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211) | 2025-09-23 |
| US | K231777 | Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W) | 2023-08-18 |
| BR | 80124630056 | ELETRODO CIRURGICO REUSAVEL OLYMPUS | Class II |
| BR | 80124630060 | FACA CIRURGICA REUSAVEL OLYMPUS | Class I |
| BR | 80124630034 | OTICA GINECOLOGICA RIGIDA | Class II |
| SA | ME0000002711SFDAA00026 | Adapter for ETD, for LT QUICKFIX | — |
| SA | ME0000002711SFDAA00029 | Leakage tester for flexible Olympus endoscopes | — |
| CA | 1721 | OES HYSTEROFIBERSCOPE SYSTEM | Class II |
| CA | 1723 | OLYMPUS OES THORACOSCOPY SYSTEM | Class II |
| CA | 1725 | OES URETERORENOFIBERSCOPE SYSTEM | Class II |