This company has registrations in United States, South Korea — 2 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 | K260544 | FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40 | 2026-03-20 |
| US | K240460 | FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259) | 2024-06-13 |
| US | K212268 | FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT | 2022-05-27 |