Kitazato Corporation is one of 79 FDA 510(k) medical device manufacturers from Japan in the dataset, ranked by real submission volume.
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
Kitazato Corporation has 13 FDA 510(k) cleared obstetrics & gynecology devices. Based in Tokyo, JP.
Latest FDA clearance: Apr 2026. Active since 2017.
Browse the complete list of FDA 510(k) cleared obstetrics & gynecology devices from this manufacturer. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Emergo Global Consulting, LLC and BIOMEDICAL SUPPLY S.L. DBA DIBIMED.
FDA 510(k) Regulatory Record - Kitazato Corporation
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