Data / Medical devices / Japan / FMD Co., Ltd. Okinawa Factory
FMD Co., Ltd. Okinawa Factory: FDA-registered device maker in Uruma Okinawa, Japan, 2 510(k) clearances
FMD Co., Ltd. Okinawa Factory is registered with the FDA (registration 3014977413) in Uruma Okinawa, Japan. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated June 13, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3014977413
- Address
- 5194-15 Katsuren Haebaru, Uruma Okinawa, Japan, 904-2311
- Owner or operator
- FMD Co., Ltd. (10052039)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- June 13, 2016
- Registered through
- 2026
- Brand names listed
- FMD Peripheral Guide Wire F-18 Flex 400, FMD Peripheral Guidewire F-14 EXT, FMD Peripheral Guidewire F-14 Flex, FMD Peripheral Guidewire F-14 Gentle, FMD Peripheral Guidewire F-14 Light, FMD Peripheral Guidewire F-14 Tapered15, FMD Peripheral Guidewire F-14 Tapered3, FMD Peripheral Guidewire F-14 Tapered30 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Wire, Guide, Catheter | DQX | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 13, 2024 | K240460 | FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259) | DQX | Substantially Equivalent | FMD Co., Ltd. | accessdata.fda.gov |
| May 27, 2022 | K212268 | FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT | DQX | Substantially Equivalent | FMD Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated June 13, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.