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)
Top companies in MQL
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 26, 2024 | CooperSurgical, Inc. Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa.
Part Number: 84055060D Open, Classified |
MQL | K153267 |
| Sep 26, 2024 | CooperSurgical, Inc. Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa.
Part Number: 84055060A Open, Classified |
MQL | K153267 |
| Sep 26, 2024 | CooperSurgical, Inc. Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of spermatozoa
Part Number: 84051010A Open, Classified |
MQL | K153267 |
| Feb 14, 2024 | CooperSurgical, 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 |
MQL | K142991 |
| Feb 6, 2024 | Fujifilm Irvine Scientific, Inc. Sperm separation media are used to separate motile sperm from other constituents of semen. Open, Classified |
MQL | K991341 |
| Apr 6, 2023 | CooperSurgical, Inc. Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Number H5GT-060 Open, Classified |
MQL | K142991 |
| Apr 1, 2023 | Fujifilm Irvine Scientific, Inc. Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305 Open, Classified |
MQL | K011938 |
| Jan 31, 2023 | CooperSurgical, Inc. BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for Pre-implantation Genetic Diagnosis (PGD) Open, Classified |
MQL | K060983 |
| Jun 13, 2022 | CooperSurgical, Inc. LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055 Open, Classified |
MQL | K092963 |
| Sep 8, 2021 | Fujifilm 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 |
MQL | K160006 |
| Sep 8, 2021 | Fujifilm 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 |
MQL | K160006 |
| Sep 8, 2020 | CooperSurgical, Inc. MediCult Vitrification Cooling Media, Model Number 12284001F Terminated |
MQL | K100367 |
| Sep 20, 2016 | CooperSurgical, 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 |
MQL | K991390 |
| Sep 20, 2016 | CooperSurgical, 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 |
MQL | K991390 |
| Mar 28, 2012 | Cook, 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 |
MQL | K022002 |
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