Medical Device Manufacturer · US , Santa Ana , CA

Fujifilm Irvine Scientific - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2023

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Fujifilm Irvine Scientific Obstetrics & Gynecology ✕

3 devices

1-3 of 3

Cleared Sep 12, 2025

Obstetrics & Gynecology · 210d

Cleared Sep 26, 2024

cryo-GO Vitrification Device

Obstetrics & Gynecology · 136d

Cleared Apr 24, 2024

SSS-NX (Serum Substitute Supplement-NX)

Obstetrics & Gynecology · 152d