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Kitazato Corporation

FDA 510(k) & PMA Approved Devices — 13 products

Total Devices13
Categories4
Latest FDA decision2026-04-28
TypeNumberDevice NameCodeDateActions
510(k) K260248 Ultra-Fast WarmMQL2026-04-28 View
510(k) K251305 Ultra-Fast Vitri; Ultra-Fast WarmMQL2025-08-26 View
510(k) K200249 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])MQL2020-10-23 View
510(k) K193522 iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHAMQL2020-08-25 View
510(k) K192845 Sperm Freeze, Sperm FridgeMQL2020-08-17 View
510(k) K192540 Kitazato ET CathetersMQF2020-05-01 View
510(k) K190199 SepaSperm Washing Solution, SepaSperm SolutionMQL2019-09-26 View
510(k) K181469 Cryotop®US-flash and Cryotop®US-scoopMQK2018-11-09 View
510(k) K182002 Cumulus RemoverMQL2018-10-23 View
510(k) K171748 Vitrification Kit and Thawing KitMQL2017-12-14 View
510(k) K162878 Kitazato ET CathetersMQF2017-07-13 View
510(k) K162881 Kitazato OPU NeedlesMQE2017-07-11 View
510(k) K162667 Kitazato IUI CatheterMQF2017-05-11 View
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