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

DateFirm and productCodeLinked 510(k)
Sep 26, 2024CooperSurgical, Inc.
Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060D
Open, Classified
MQLK153267
Sep 26, 2024CooperSurgical, Inc.
Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060A
Open, Classified
MQLK153267
Sep 26, 2024CooperSurgical, Inc.
Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of spermatozoa Part Number: 84051010A
Open, Classified
MQLK153267
Feb 14, 2024CooperSurgical, Inc.
global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle). Intended use: Culture of human embryos from zygote to blastocyst, embryo transfer.
Open, Classified
MQLK142991
Feb 6, 2024Fujifilm Irvine Scientific, Inc.
Sperm separation media are used to separate motile sperm from other constituents of semen.
Open, Classified
MQLK991341
Apr 6, 2023CooperSurgical, Inc.
Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Number H5GT-060
Open, Classified
MQLK142991
Apr 1, 2023Fujifilm Irvine Scientific, Inc.
Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305
Open, Classified
MQLK011938
Jan 31, 2023CooperSurgical, Inc.
BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for Pre-implantation Genetic Diagnosis (PGD)
Open, Classified
MQLK060983
Jun 13, 2022CooperSurgical, Inc.
LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055
Open, Classified
MQLK092963
Sep 8, 2021Fujifilm Irvine Scientific, Inc.
Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage of human oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst
Open, Classified
MQLK160006
Sep 8, 2021Fujifilm Irvine Scientific, Inc.
Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage of human oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst
Open, Classified
MQLK160006
Sep 8, 2020CooperSurgical, Inc.
MediCult Vitrification Cooling Media, Model Number 12284001F
Terminated
MQLK100367
Sep 20, 2016CooperSurgical, Inc.
Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Thawing Medium Product Number: ART-8018 Intended for use in freezing embryos. This product is intended for thawing of embryos f
Terminated
MQLK991390
Sep 20, 2016CooperSurgical, Inc.
Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Freezing Medium . Product Number: ART -8017 SAGE In Vitro Fertilization, Inc. A CooperSurgical Company 95 Corporate Drive Trumb
Terminated
MQLK991390
Mar 28, 2012Cook, Inc.
Sydney IVF Culture Oil, REF, K- SICO- 50, 50 mL. and K-SICO-200, 200 mL,Store at 2-8 C, Sterile, Cook Medical, William A Cook Australia LTD, Product Usage: Culture oil is intended to be used as an
Terminated
MQLK022002

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