Data / Medical devices / Japan / FMD. Co., Ltd.
FMD. Co., Ltd.: FDA-registered device maker in Komaki Aichi, Japan, 5 510(k) clearances
FMD. Co., Ltd. is registered with the FDA (registration 3013023134) in Komaki Aichi, Japan. It lists 1 device type. The FDA files 5 510(k) clearances under its listings, the newest dated June 13, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013023134
- Address
- 1-166 Shimoobari Nakashima, Komaki Aichi, Japan, 485-0051
- Owner or operator
- FMD Co., Ltd. (10052039)
- Roles
- Manufacturer, Specification developer
- 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 | Manufacturer, Specification developer | 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 |
| April 12, 2018 | K180795 | JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire | DQX | Substantially Equivalent | Boston Scientific | accessdata.fda.gov |
| February 12, 2016 | K152231 | Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire | DQX | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| December 16, 2015 | K151840 | Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch Extension Wire | DQX | Substantially Equivalent | Boston Scientific Corporation | 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.