ClearanceBrief
Panels › Obstetrics/Gynecology › Product code MQL · Class 2

Media, Reproductive

Regulation 884.6180

3510(k)s in 12 months (260 all time)
0recalls in 12 months (15 all time)
15recalls that name a 510(k)
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Top companies in MQL

Company510(k)sRecalls
Irvine Scientific Sales Co., Inc.360
Vitrolife Sweden AB280
Medicult A/S260
<Genx> Intl., Inc.200
CooperSurgical, Inc.210
Nidacon International AB110
Invitrocare, Inc.100
Origio A/S100
William A. Cook Australia Pty. , Ltd.100
Kitazato Corporation80
Decided510(k)Device and applicantCode
Aug 28, 2026K254261Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)
CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD., CN
MQL
Apr 28, 2026K260248Ultra-Fast Warm
Kitazato Corporation, JP
MQL
Feb 20, 2026K252672CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)
Casebioscience, Inc., CA
MQL
Sep 12, 2025K250445Fast Warm - NX
Fujifilm Irvine Scientific
MQL
Aug 27, 2025K251637Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One St
Donnevie Medical Technology (Shanghai) Co. , Ltd., CN
MQL
Aug 26, 2025K251305Ultra-Fast Vitri; Ultra-Fast Warm
Kitazato Corporation, JP
MQL
May 30, 2025K242640FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin
Fertipro NV, BE
MQL
Apr 10, 2025K242561Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)
Donnevie Medical Technology (Shanghai) Co. , Ltd., CN
MQL
Apr 10, 2025K242089Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)
Jiangsu Ruifuda Medical Device Co., Ltd., CN
MQL
Mar 21, 2025K242107CaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF)
Casebioscience, Inc., CA
MQL
Mar 21, 2025K241833V-GRAD
Vitromed GmbH, DE
MQL
Jan 8, 2025K242043Sperm Freezing Medium
Gimbo Medical Technology Shenzhen Co., Ltd., CN
MQL
Dec 18, 2024K241132ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100)
Artsmedia Denmark Aps, DK
MQL
Dec 18, 2024K241095ARTSMedia Semen Wash Medium
Artsmedia Denmark Aps, DK
MQL
Nov 22, 2024K242968Giftlife® Single-Step Medium Plus
Gimbo Medical Technology Shenzhen Co., Ltd., CN
MQL
Sep 13, 2024K240176V-VITFREEZE and V-VITWARM
Vitromed GmbH, DE
MQL
Aug 27, 2024K233846Vitrification Solution Set and Warming Solution Set
Ecmpc, LLC
MQL
Aug 7, 2024K240605Ultra RapidWarm™ Blast
Vitrolife Sweden AB, SE
MQL
Jul 1, 2024K233477Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML)
Shandong Wego Ruisheng Medical Device Co., Ltd., CN
MQL
Jun 13, 2024K240149Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™ Blastocyst Medium; Giftlife™ Single Step Medium
Gimbo Medical Technology Shenzhen Co., Ltd., CN
MQL
May 10, 2024K234023Oocyte Flushing & Retrieval Medium; Gamete Buffer
Gimbo Medical Technology Shenzhen Co., Ltd., CN
MQL
Apr 24, 2024K233764SSS-NX (Serum Substitute Supplement-NX)
Fujifilm Irvine Scientific
MQL
Mar 20, 2024K232125V-PVP
Vitromed GmbH, DE
MQL
Jan 30, 2024K232942G-Vitri™ Vitrification Freeze Media; G-Vitri™ Vitrification Thawing Media
Gimbo Medical Technology Shenzhen Co., Ltd., CN
MQL
Aug 4, 2023K231370Dewin Blastocyst Medium (with HSA and without HSA)
Donnevie Medical Technology (Shanghai) Co. , Ltd., CN
MQL
May 26, 2023K222606V-HYADASE
Vitromed GmbH, DE
MQL
May 11, 2023K223265CryoX Vitrification Freeze Kit / Thaw Kit
Zhejiang Horizon Medical Technology Co., Ltd., CN
MQL
Feb 10, 2023K220715ARTSMedia In Vitro Culture Medium (AM-IVC Medium)
Artsmedia Denmark Aps, DK
MQL
Jan 31, 2023K223117V-SPERM WASH
Vitromed GmbH, DE
MQL
Sep 14, 2022K213293V-HEPES PLUS
Vitromed Langenfeld, DE
MQL
Jun 16, 2022K212426Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and
Donnevie Medical Technology (Shanghai) Co. , Ltd., CN
MQL
Feb 1, 2022K212410VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium
Shenzhen Vitavitro Biotech Co., Ltd., CN
MQL
May 14, 2021K202862Gx-IVF, Gx-TL, Gx-MOPS PLUS
Vitrolife Sweden AB, SE
MQL
Nov 20, 2020K193285V-ONESTEP
Vitromed GmbH, DE
MQL
Nov 19, 2020K192503GM501 Wash with Phenol Red and Gentamicin
Hamilton Thorne Incorporated
MQL
Oct 23, 2020K200249Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA], Cleavage Medium [without HSA/rHA,
Kitazato Corporation, JP
MQL
Oct 16, 2020K200408VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium
Shenzhen Vitavitro Biotech Co., Ltd., CN
MQL
Aug 25, 2020K193522iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA
Kitazato Corporation, JP
MQL
Aug 17, 2020K192845Sperm Freeze, Sperm Fridge
Kitazato Corporation, JP
MQL
Jul 17, 2020K200680Synvitro Hyadase
Origio A/S, A Coopersurgical Company, DK
MQL
Apr 23, 2020K192644GM501 SpermAir and GM501 SpermActive
Hamilton Thorne Incorporated
MQL
Sep 26, 2019K190199SepaSperm Washing Solution, SepaSperm Solution
Kitazato Corporation, JP
MQL
Sep 18, 2019K191552GM501 Mineral Oil
Hamilton Thorne, Inc.
MQL
Sep 5, 2019K190383GM501 Wash
Hamilton Thorne, Inc.
MQL
Aug 23, 2019K1910631-Step Culture Medium
Shenzhen Vitavitro Biotech Co., Ltd., CN
MQL
Jul 26, 2019K183486RapidVit™ Oocyte, RapidWarm™ Oocyte
Vitrolife Sweden AB, SE
MQL
Jun 21, 2019K190152Vit Kit- Freeze NX and Vit Kit- Warm NX
Fujifilm Irvine Scientific, Inc.
MQL
Oct 23, 2018K182002Cumulus Remover
Kitazato Corporation, JP
MQL
Aug 29, 2018K180073Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set
Shenzhen Vitavitro Bio-Tech Co., Ltd., CN
MQL
Mar 2, 2018K173731SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031)
CooperSurgical, Inc.
MQL

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