Home › Device types › MQL
Media, Reproductive
FDA product code MQL · Class 2 · Obstetrics/Gynecology
736
Registered devices
24
Adverse events
15
Recalls
259
510(k) clearances
Devices with this code
ARTSMedia Semen Wash Medium (AM Semen Wash) — Artsmedia Denmark ApSGx-MOPS PLUS — Vitrolife Sweden ABV-GRAD 40 — VITROMED GmbHComplete Early Cleavage Medium® (ECM®) with SSS — FUJIFILM IRVINE SCIENTIFIC, INC.ORIGIO Sequential Cleav — Coopersurgical, Inc.RapidVit Blast — Vitrolife Sweden ABComplete HTF Medium with SSS™ — FUJIFILM IRVINE SCIENTIFIC, INC.SPERM WASH MEDIUM for Swim-Up — INVITROCARE, INCORPORATEDVitriFreeze — Fertipro NVSil-Select Plus Lower Layer — Fertipro NVEnhance-S Plus — VITROLIFE INC.PureCeption 24 - Determination Bi-Layer Kit — Coopersurgical, Inc.DEWIN — DonneVie Medical Technology(Shanghai)Co.LtdQUINN'S Sperm Washing Kit — Coopersurgical, Inc.Heavy Oil for Embryo Culture — IRVINE SCIENTIFIC, LLCHypure Oil Heavy 100mL — KITAZATO CORPORATIONORIGIO Sequential Blast — Coopersurgical, Inc.EmbryoAssist — Origio A/SSperm Freeze — KITAZATO CORPORATIONG-MM — Vitrolife Sweden ABUTM — Coopersurgical, Inc.HYALURONIDASE — INVITROCARE, INCORPORATEDHuman Serum Albumin Solution — FUJIFILM IRVINE SCIENTIFIC, INC.SpermFilter Ready-to-use gradient 80% 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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.