Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Media, Reproductive

FDA product code MQL · 248 cleared devices

Class 2 Obstetrics/Gynecology

Regulation: 21 CFR 884.6180
Review panel: OB
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1987-02-02 – 2026-08-28

MQL 2026-08-28

Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)

Applicant CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD.

K number K254261

View details →

MQL 2026-04-28

Ultra-Fast Warm

Applicant Kitazato Corporation

K number K260248

View details →

MQL 2026-02-20

CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)

Applicant Casebioscience, Inc.

K number K252672

View details →

MQL 2025-09-12

Fast Warm - NX

Applicant Fujifilm Irvine Scientific

K number K250445

View details →

MQL 2025-08-27

Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])

Applicant Donnevie Medical Technology (Shanghai) Co. , Ltd.

K number K251637

View details →

MQL 2025-08-26

Ultra-Fast Vitri; Ultra-Fast Warm

Applicant Kitazato Corporation

K number K251305

View details →

MQL 2025-05-30

FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin

Applicant Fertipro NV

K number K242640

View details →

MQL 2025-04-10

Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)

Applicant Donnevie Medical Technology (Shanghai) Co. , Ltd.

K number K242561

View details →

MQL 2025-04-10

Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)

Applicant Jiangsu Ruifuda Medical Device Co., Ltd.

K number K242089

View details →

MQL 2025-03-21

CaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF)

Applicant Casebioscience, Inc.

K number K242107

View details →

MQL 2025-03-21

V-GRAD

Applicant Vitromed GmbH

K number K241833

View details →

MQL 2025-01-08

Sperm Freezing Medium

Applicant Gimbo Medical Technology Shenzhen Co., Ltd.

K number K242043

View details →

MQL 2024-12-18

ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100)

Applicant Artsmedia Denmark Aps

K number K241132

View details →

MQL 2024-12-18

ARTSMedia Semen Wash Medium

Applicant Artsmedia Denmark Aps

K number K241095

View details →

MQL 2024-11-22

Giftlife® Single-Step Medium Plus

Applicant Gimbo Medical Technology Shenzhen Co., Ltd.

K number K242968

View details →

MQL 2024-09-13

V-VITFREEZE and V-VITWARM

Applicant Vitromed GmbH

K number K240176

View details →

MQL 2024-08-27

Vitrification Solution Set and Warming Solution Set

Applicant Ecmpc, LLC

K number K233846

View details →

MQL 2024-08-07

Ultra RapidWarm™ Blast

Applicant Vitrolife Sweden AB

K number K240605

View details →

MQL 2024-07-01

Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML)

Applicant Shandong Wego Ruisheng Medical Device Co., Ltd.

K number K233477

View details →

MQL 2024-06-13

Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™ Blastocyst Medium; Giftlife™ Single Step Medium

Applicant Gimbo Medical Technology Shenzhen Co., Ltd.

K number K240149

View details →

MQL 2024-05-10

Oocyte Flushing & Retrieval Medium; Gamete Buffer

Applicant Gimbo Medical Technology Shenzhen Co., Ltd.

K number K234023

View details →

MQL 2024-04-24

SSS-NX (Serum Substitute Supplement-NX)

Applicant Fujifilm Irvine Scientific

K number K233764

View details →

MQL 2024-03-20

V-PVP

Applicant Vitromed GmbH

K number K232125

View details →

MQL 2024-01-30

G-Vitri™ Vitrification Freeze Media; G-Vitri™ Vitrification Thawing Media

Applicant Gimbo Medical Technology Shenzhen Co., Ltd.

K number K232942

View details →

MQL 2023-08-04

Dewin Blastocyst Medium (with HSA and without HSA)

Applicant Donnevie Medical Technology (Shanghai) Co. , Ltd.

K number K231370

View details →

MQL 2023-05-26

V-HYADASE

Applicant Vitromed GmbH

K number K222606

View details →

MQL 2023-05-11

CryoX Vitrification Freeze Kit / Thaw Kit

Applicant Zhejiang Horizon Medical Technology Co., Ltd.

K number K223265

View details →

MQL 2023-02-10

ARTSMedia In Vitro Culture Medium (AM-IVC Medium)

Applicant Artsmedia Denmark Aps

K number K220715

View details →

MQL 2023-01-31

V-SPERM WASH

Applicant Vitromed GmbH

K number K223117

View details →

MQL 2022-09-14

V-HEPES PLUS

Applicant Vitromed Langenfeld

K number K213293

View details →

MQL 2022-06-16

Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA])

Applicant Donnevie Medical Technology (Shanghai) Co. , Ltd.

K number K212426

View details →

MQL 2022-02-01

VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium

Applicant Shenzhen Vitavitro Biotech Co., Ltd.

K number K212410

View details →

MQL 2021-05-14

Gx-IVF, Gx-TL, Gx-MOPS PLUS

Applicant Vitrolife Sweden AB

K number K202862

View details →

MQL 2020-11-20

V-ONESTEP

Applicant Vitromed GmbH

K number K193285

View details →

MQL 2020-11-19

GM501 Wash with Phenol Red and Gentamicin

Applicant Hamilton Thorne Incorporated

K number K192503

View details →

MQL 2020-10-23

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])

Applicant Kitazato Corporation

K number K200249

View details →

MQL 2020-10-16

VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium

Applicant Shenzhen Vitavitro Biotech Co., Ltd.

K number K200408

View details →

MQL 2020-08-25

iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA

Applicant Kitazato Corporation

K number K193522

View details →

MQL 2020-08-17

Sperm Freeze, Sperm Fridge

Applicant Kitazato Corporation

K number K192845

View details →

MQL 2020-07-17

Synvitro Hyadase

Applicant Origio A/S, A Coopersurgical Company

K number K200680

View details →

MQL 2020-04-23

GM501 SpermAir and GM501 SpermActive

Applicant Hamilton Thorne Incorporated

K number K192644

View details →

MQL 2019-09-26

SepaSperm Washing Solution, SepaSperm Solution

Applicant Kitazato Corporation

K number K190199

View details →

MQL 2019-09-18

GM501 Mineral Oil

Applicant Hamilton Thorne, Inc.

K number K191552

View details →

MQL 2019-09-05

GM501 Wash

Applicant Hamilton Thorne, Inc.

K number K190383

View details →

MQL 2019-08-23

1-Step Culture Medium

Applicant Shenzhen Vitavitro Biotech Co., Ltd.

K number K191063

View details →

MQL 2019-07-26

RapidVit™ Oocyte, RapidWarm™ Oocyte

Applicant Vitrolife Sweden AB

K number K183486

View details →

MQL 2019-06-21

Vit Kit- Freeze NX and Vit Kit- Warm NX

Applicant Fujifilm Irvine Scientific, Inc.

K number K190152

View details →

MQL 2018-10-23

Cumulus Remover

Applicant Kitazato Corporation

K number K182002

View details →

MQL 2018-08-29

Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set

Applicant Shenzhen Vitavitro Bio-Tech Co., Ltd.

K number K180073

View details →

MQL 2018-03-02

SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031)

Applicant CooperSurgical, Inc.

K number K173731

View details →

MQL 2018-03-02

ORIGIO® Handling™ without phenol red (Cat. No. 8310), ORIGIO® Handling™ with phenol red (Cat. No. 8311)

Applicant Origio A/S

K number K173624

View details →

MQL 2017-12-14

Vitrification Kit and Thawing Kit

Applicant Kitazato Corporation

K number K171748

View details →

MQL 2017-10-13

SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS

Applicant Origio A/S

K number K172197

View details →

MQL 2017-09-28

Gems Oocyte Retrieval Buffer ORB-20, ORB-50

Applicant Genea Biomedx Pty, Ltd.

K number K170498

View details →

MQL 2017-08-31

Arctic Sperm Cryopreservation Medium

Applicant Irvine Scientific Sales Co., Inc.

K number K171224

View details →

MQL 2017-06-08

Continuous Single Culture -NX (CSCM-NX)

Applicant Irvine Scientific Sales Co., Inc.

K number K170681

View details →

MQL 2017-06-07

Continuous Single Culture-NX Complete (CSCM-NXC)

Applicant Irvine Scientific Sales Co., Inc.

K number K170602

View details →

MQL 2017-05-24

Gems Vitrification Set, Gems Warming Set

Applicant Genea Biomedx Pty, Ltd.

K number K162409

View details →

MQL 2017-05-12

Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase

Applicant Genea Biomedx Pty, Ltd.

K number K161261

View details →

MQL 2017-04-04

SAGE Vitrification Kit and SAGE Vitrification Warming Kit

Applicant CooperSurgical, Inc.

K number K170560

View details →

MQL 2017-02-24

Sydney IVF Culture Oil

Applicant William A. Cook Australia Pty. , Ltd.

K number K170257

View details →

MQL 2016-10-07

Cryotop Vitrification Kit and Cryotop Thawing Kit

Applicant Kitazato Biopharma Co., Ltd.

K number K160864

View details →

MQL 2016-08-15

Sydney IVF Gamete Buffer

Applicant William A. Cook Australia Pty. , Ltd.

K number K153478

View details →

MQL 2016-07-28

PBS(-), Phosphate Buffered Saline

Applicant Kitazato Biopharma Co., Ltd.

K number K160863

View details →

MQL 2016-07-22

ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash

Applicant Origio A/S

K number K153267

View details →

MQL 2016-05-06

Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit

Applicant William A. Cook Australia Pty. , Ltd.

K number K152717

View details →

MQL 2016-05-05

Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit

Applicant Willian A. Cook Australia Pty, Ltd.

K number K152682

View details →

MQL 2016-05-04

Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw Oocytes, Embryos and PN zygotes Vitrification Thaw Kit

Applicant Irvine Scientific

K number K160006

View details →

MQL 2016-04-22

Sydney IVF Sperm Cryopreservation Buffer

Applicant William A. Cook Australia Pty. , Ltd.

K number K160814

View details →

MQL 2016-04-21

MINERAL OIL

Applicant Kitazato Biopharma Co., Ltd.

K number K160142

View details →

MQL 2016-02-29

BlastGen

Applicant Origio A/S

K number K152932

View details →

MQL 2016-01-27

Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium

Applicant William A. Cook Australia Pty. , Ltd.

K number K153290

View details →

MQL 2016-01-27

Sydney IVF Hyaluronidase

Applicant William A. Cook Australia Pty. , Ltd.

K number K151367

View details →

MQL 2012-10-26

SPERMFREEZE SOLUTION

Applicant Vitrolife Sweden AB

K number K113786

View details →

MQL 2012-09-26

EMBRYOGEN

Applicant Origio A/S

K number K120136

View details →

MQL 2012-07-19

CONTINUOUS SINGLE CULTURE COMPLETE

Applicant Irvine Scientific Sales Co., Inc.

K number K121572

View details →

MQL 2012-06-06

MULTIPURPOSE HANDLING MEDIUM

Applicant Irvine Scientific Sales Co., Inc.

K number K121128

View details →

MQL 2012-05-03

LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPES

Applicant <Genx> Intl., Inc.

K number K112083

View details →

MQL 2011-01-14

GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3

Applicant Genx Intl., Inc.

K number K092963

View details →

MQL 2010-12-10

RAPIDVIT BLAST, RAPIDWARM BLAST

Applicant Vitrolife Sweden AB

K number K101003

View details →

MQL 2010-08-27

MEDICULT VITRIFICATION COOLING/WARMING, MODEL REF: 1228, 1229

Applicant Origio A/S

K number K100367

View details →

MQL 2010-06-15

VITRIBLAST, THERMOBLAST, MODEL VB-010, TB-010

Applicant Nidacon International AB

K number K092107

View details →

MQL 2010-06-03

GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT

Applicant Genx Intl., Inc.

K number K092667

View details →

MQL 2010-04-05

LIFEGLOBAL PROTEIN SUPPLEMENT

Applicant Genx Intl., Inc.

K number K092578

View details →

MQL 2010-03-03

VIT KIT - FREEZE AND THAW

Applicant Irvine Scientific Sales Co., Inc.

K number K093273

View details →

MQL 2009-04-29

COOK SYDNEY IVF BLASTOCYST VITRIFICATION (K-SIBV-5000), WARMING (K-SIBW-5000) KITS

Applicant William A. Cook Australia Pty. , Ltd.

K number K082363

View details →

MQL 2009-04-24

LIFEGLOBAL HUMAN SERUM ALBUMIN LG HSA

Applicant Genx Intl., Inc.

K number K083509

View details →

MQL 2008-12-18

BLASTASSIST WITHOUT PHENOL RED, MODEL REF 1215, BLASTASSIST WITH PHENOL RED, MODEL REF 1216

Applicant Medicult A/S

K number K080172

View details →

MQL 2008-11-26

RAPIDVIT AND RAPIDWARM CLEAVE

Applicant Vitrolife Sweden AB

K number K080446

View details →

MQL 2008-10-10

VITRIFICATION KIT & VITRIFICATION WARMING KIT

Applicant Sage In-Vitro Fertilization, Inc.

K number K073522

View details →

MQL 2008-09-19

ICSI CUMULASE

Applicant Medicult A/S

K number K081639

View details →

MQL 2008-09-17

G-MOPS G5 SERIES

Applicant Vitrolife Sweden AB

K number K081115

View details →

MQL 2008-09-16

G-2 V5

Applicant Vitrolife Sweden AB

K number K081117

View details →

MQL 2008-09-16

G-1 V5

Applicant Vitrolife Sweden AB

K number K081114

View details →

MQL 2008-09-03

EMBRYOASSIST AND EMBRYOASSIST WITH PHENOL RED

Applicant Medicult A/S

K number K080473

View details →

MQL 2008-09-02

G-IVF G5 SERIES

Applicant Vitrolife Sweden AB

K number K081116

View details →

MQL 2008-02-12

SINGLE STEP MEDIUM

Applicant Irvine Scientific Sales Co., Inc.

K number K072609

View details →

MQL 2008-01-30

LYOPHILIZED MULTIBLAST MEDIUM KIT

Applicant Irvine Scientific Sales Co., Inc.

K number K072608

View details →

MQL 2008-01-25

LYOPHILIZED EARLY CLEAVAGE MEDIUM (ECM) KIT

Applicant Irvine Scientific Sales Co., Inc.

K number K072607

View details →

MQL 2007-08-16

VITRIFREEZE MEDIUM; VITRITHAW MEDIUM

Applicant Fertipro NV

K number K070135

View details →

↑