MQL · Class II · 21 CFR 884.6180

FDA Product Code MQL: Media, Reproductive

Leading manufacturers include Kitazato Corporation, Vitromed GmbH and Gimbo Medical Technology Shenzhen Co., Ltd..

259
Total
259
Cleared
158d
Avg days
1987
Since
259 devices
25–48 of 259
Cleared May 26, 2023
V-HYADASE
K222606
Vitromed GmbH
Obstetrics & Gynecology · 270d
Cleared May 11, 2023
CryoX Vitrification Freeze Kit / Thaw Kit
K223265
Zhejiang Horizon Medical Technology Co., Ltd.
Obstetrics & Gynecology · 199d
Cleared Feb 10, 2023
ARTSMedia In Vitro Culture Medium (AM-IVC Medium)
K220715
Artsmedia Denmark Aps
Obstetrics & Gynecology · 336d
Cleared Jan 31, 2023
V-SPERM WASH
K223117
Vitromed GmbH
Obstetrics & Gynecology · 120d
Cleared Sep 14, 2022
V-HEPES PLUS
K213293
Vitromed Langenfeld
Obstetrics & Gynecology · 348d
Cleared Jun 16, 2022
Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA])
K212426
Donnevie Medical Technology (Shanghai) Co. , Ltd.
Obstetrics & Gynecology · 316d
Cleared Feb 01, 2022
VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium
K212410
Shenzhen Vitavitro Biotech Co., Ltd.
Obstetrics & Gynecology · 182d
Cleared May 14, 2021
Gx-IVF, Gx-TL, Gx-MOPS PLUS
K202862
Vitrolife Sweden AB
Obstetrics & Gynecology · 228d
Cleared Nov 20, 2020
V-ONESTEP
K193285
Vitromed GmbH
Obstetrics & Gynecology · 359d
Cleared Nov 19, 2020
GM501 Wash with Phenol Red and Gentamicin
K192503
Hamilton Thorne Incorporated
Obstetrics & Gynecology · 434d
Cleared Oct 23, 2020
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
Kitazato Corporation
Obstetrics & Gynecology · 263d
Cleared Oct 16, 2020
VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium
K200408
Shenzhen Vitavitro Biotech Co., Ltd.
Obstetrics & Gynecology · 240d
Cleared Aug 25, 2020
iMedium Single Step
K193522
Kitazato Corporation
Obstetrics & Gynecology · 250d
Cleared Aug 17, 2020
Sperm Freeze, Sperm Fridge
K192845
Kitazato Corporation
Obstetrics & Gynecology · 319d
Cleared Jul 17, 2020
Synvitro Hyadase
K200680
Origio A/S, A Coopersurgical Company
Obstetrics & Gynecology · 123d
Cleared Apr 23, 2020
GM501 SpermAir and GM501 SpermActive
K192644
Hamilton Thorne Incorporated
Obstetrics & Gynecology · 212d
Cleared Sep 26, 2019
SepaSperm Washing Solution, SepaSperm Solution
K190199
Kitazato Corporation
Obstetrics & Gynecology · 234d
Cleared Sep 18, 2019
GM501 Mineral Oil
K191552
Hamilton Thorne, Inc.
Obstetrics & Gynecology · 98d
Cleared Sep 05, 2019
GM501 Wash
K190383
Hamilton Thorne, Inc.
Obstetrics & Gynecology · 198d
Cleared Aug 23, 2019
1-Step Culture Medium
K191063
Shenzhen Vitavitro Biotech Co., Ltd.
Obstetrics & Gynecology · 123d
Cleared Jul 26, 2019
RapidVit™ Oocyte, RapidWarm™ Oocyte
K183486
Vitrolife Sweden AB
Obstetrics & Gynecology · 221d
Cleared Jun 21, 2019
Vit Kit- Freeze NX and Vit Kit- Warm NX
K190152
Fujifilm Irvine Scientific, Inc.
Obstetrics & Gynecology · 142d
Cleared Oct 23, 2018
Cumulus Remover
K182002
Kitazato Corporation
Obstetrics & Gynecology · 89d
Cleared Aug 29, 2018
Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set
K180073
Shenzhen Vitavitro Bio-Tech Co., Ltd.
Obstetrics & Gynecology · 232d