Home › Device types › MQL
Media, Reproductive
FDA product code MQL · Class 2 · Obstetrics/Gynecology
855
Registered devices
24
Adverse events
15
Recalls
260
510(k) clearances
Devices with this code
Giftlife™ Fertilization Medium — Gimbo Medical Technology Shenzhen Co., Ltd.Sil-Select Plus 80% — Fertipro NVmHTF — VITROLIFE INC.Freezing Medium - TEST Yolk Buffer (TYB) with Glycerol and Gentamicin — FUJIFILM IRVINE SCIENTIFIC, INC.LifeGlobal® Media — LIFEGLOBAL GROUP, LLCLifeGlobal® Media — LIFEGLOBAL GROUP, LLCSpermCryo All-round USA — Gynotec.B.V.VitaVitro — SHENZHEN VITAVITRO BIOTECH CO.,LTD.TS(Thawing Solution) — KITAZATO CORPORATIONDEWIN — DonneVie Medical Technology(Shanghai)Co.LtdSpermGrad — Vitrolife Sweden ABUltra-Fast Vitri — KITAZATO CORPORATIONOil for Embryo Culture — IRVINE SCIENTIFIC, LLCG-FreezeKit Blast — Vitrolife Sweden ABSydney IVF — WILLIAM A. COOK AUSTRALIA PTY. LTD.SpermFilter Ready-to-use gradient 45% USA — Gynotec.B.V.Nidacon — Nidacon International ABGiftlife™ Blastocyst Medium — Gimbo Medical Technology Shenzhen Co., Ltd.Hyaluronidase Solution — IRVINE SCIENTIFIC, LLCSPERM WASH MEDIUM — INVITROCARE, INCORPORATEDLifeGlobal® Media — Coopersurgical, Inc.Multipurpose Handling Medium - Complete (MHM-C) with Gentamicin and HSA — IRVINE SCIENTIFIC, LLCLifeGlobal® Media — Coopersurgical, Inc.SpermFilter Ready-to-use gradient 45% USA — Gynotec.B.V.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-02-16 | CooperSurgical, Inc. | Low concentration of sodium pyruvate in the wash could compromise gamete development |
| 2024-02-16 | CooperSurgical, Inc. | Low concentration of sodium pyruvate in the wash could compromise gamete development |
| 2024-02-16 | CooperSurgical, Inc. | Low concentration of sodium pyruvate in the wash could compromise gamete development |
| 2023-12-20 | CooperSurgical, Inc. | The firm has become aware of a sudden increase in complaints for three associated lots. Performance issues may lead to impaired embryo development prior to the |
| 2023-11-02 | Fujifilm Irvine Scientific, Inc. | The lower layer component of a sperm separation Kit does not match the certificate of analysis. The kit should contain lower layer (Lot: 0000020686, Shelf Life: |
| 2023-02-13 | CooperSurgical, Inc. | It has come to CooperSurgical's attention that the affected Product may contain a medium other than the Global Total LP single step medium which does not contai |
| 2023-01-16 | Fujifilm Irvine Scientific, Inc. | Due to the detection of oil toxicity in several lots of Oil for Embryo Culture products. |
| 2022-12-15 | CooperSurgical, Inc. | The affected product may contain a medium other than the Biopsy Medium. There is a risk that use of the Product from this lot could cause degradation of the em |
| 2022-06-13 | CooperSurgical, Inc. | There was translation error in the Spanish version of the IFU where the Spanish version instructs the user to leave the blastocyte to air thaw for 5 minutes rat |
| 2021-09-08 | Fujifilm Irvine Scientific, Inc. | Due to a component in kit being labeled with the incorrect Expiration Date |
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