Medical Device Manufacturer · JP , Tokyo

Kitazato Corporation

12 submissions · 12 cleared · Since 2017
12
Total
12
Cleared
0
Denied

Kitazato Corporation — FDA 510(k) Submissions

Kitazato Corporation has submitted 12 FDA 510(k) premarket notifications since 2017, of which 12 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Media, Reproductive, Catheter, Assisted Reproduction, Labware, Assisted Reproduction, Needle, Assisted Reproduction . Use the specialty filter in the sidebar to narrow results.

12 devices
1–12 of 12
Ultra-Fast Vitri; Ultra-Fast Warm
K251305 · MQL Media, Reproductive · Obstetrics & Gynecology
Aug 2025 120d
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])
K200249 · MQL Media, Reproductive · Obstetrics & Gynecology
Oct 2020 263d
iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA
K193522 · MQL Media, Reproductive · Obstetrics & Gynecology
Aug 2020 250d
Sperm Freeze, Sperm Fridge
K192845 · MQL Media, Reproductive · Obstetrics & Gynecology
Aug 2020 319d
Kitazato ET Catheters
K192540 · MQF Catheter, Assisted... · Obstetrics & Gynecology
May 2020 228d
SepaSperm Washing Solution, SepaSperm Solution
K190199 · MQL Media, Reproductive · Obstetrics & Gynecology
Sep 2019 234d
Cryotop?US-flash and Cryotop?US-scoop
K181469 · MQK Labware, Assisted... · Obstetrics & Gynecology
Nov 2018 158d
Cumulus Remover
K182002 · MQL Media, Reproductive · Obstetrics & Gynecology
Oct 2018 89d
Vitrification Kit and Thawing Kit
K171748 · MQL Media, Reproductive · Obstetrics & Gynecology
Dec 2017 184d
Kitazato ET Catheters
K162878 · MQF Catheter, Assisted... · Obstetrics & Gynecology
Jul 2017 272d
Kitazato OPU Needles
K162881 · MQE Needle, Assisted... · Obstetrics & Gynecology
Jul 2017 270d
Kitazato IUI Catheter
K162667 · MQF Catheter, Assisted... · Obstetrics & Gynecology
May 2017 227d
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