Kitazato Corporation - FDA 510(k) Cleared Devices
Recent clearances: Ultra-Fast Warm, Ultra-Fast Vitri, Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA], Cleavage Medium [without HSA/rHA, with HSA, with rHA], Blastocyst Medium [without HSA/rHA, with HSA, with rHA])
13
Total
13
Cleared
0
Denied
FDA 510(k) Regulatory Record - Kitazato Corporation Obstetrics & Gynecology ✕
13 devices
Cleared
Apr 28, 2026
Ultra-Fast Warm
Obstetrics & Gynecology
91d
Cleared
Aug 26, 2025
Ultra-Fast Vitri
Obstetrics & Gynecology
120d
Cleared
Oct 23, 2020
Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA,...
Obstetrics & Gynecology
263d
Cleared
Aug 25, 2020
iMedium Single Step
Obstetrics & Gynecology
250d
Cleared
Aug 17, 2020
Sperm Freeze, Sperm Fridge
Obstetrics & Gynecology
319d
Cleared
May 01, 2020
Kitazato ET Catheters
Obstetrics & Gynecology
228d
Cleared
Sep 26, 2019
SepaSperm Washing Solution, SepaSperm Solution
Obstetrics & Gynecology
234d
Cleared
Nov 09, 2018
Cryotop®US-flash and Cryotop®US-scoop
Obstetrics & Gynecology
158d
Cleared
Oct 23, 2018
Cumulus Remover
Obstetrics & Gynecology
89d
Cleared
Dec 14, 2017
Vitrification Kit and Thawing Kit
Obstetrics & Gynecology
184d
Cleared
Jul 13, 2017
Kitazato ET Catheters
Obstetrics & Gynecology
272d
Cleared
Jul 11, 2017
Kitazato OPU Needles
Obstetrics & Gynecology
270d