Medical Device Manufacturer · JP , Shibuya-Ku

FMD Co., Ltd. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2022

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - FMD Co., Ltd. Cardiovascular ✕

3 devices

1-3 of 3

Cleared Mar 20, 2026

FMD Peripheral Guide Wire F-14 Flex 6

Cardiovascular · 30d

Cleared Jun 13, 2024

FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259)

Cardiovascular · 118d

Cleared May 27, 2022

FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT

Cardiovascular · 311d