Kitazato Corporation

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
12
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K251305Ultra-Fast Vitri; Ultra-Fast WarmAugust 26, 2025
K200249Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA], Cleavage MediuOctober 23, 2020
K193522iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHAAugust 25, 2020
K192845Sperm Freeze, Sperm FridgeAugust 17, 2020
K192540Kitazato ET CathetersMay 1, 2020
K190199SepaSperm Washing Solution, SepaSperm SolutionSeptember 26, 2019
K181469Cryotop®US-flash and Cryotop®US-scoopNovember 9, 2018
K182002Cumulus RemoverOctober 23, 2018
K171748Vitrification Kit and Thawing KitDecember 14, 2017
K162878Kitazato ET CathetersJuly 13, 2017
K162881Kitazato OPU NeedlesJuly 11, 2017
K162667Kitazato IUI CatheterMay 11, 2017