Fuji, JP · 6 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| MQL | Media, Reproductive | Class II | Obstetrics/Gynecology | 5 | 2026-04-28 |
| MQF | Catheter, Assisted Reproduction | Class II | Obstetrics/Gynecology | 1 | 2020-05-01 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-04-28 | K260248 | Ultra-Fast Warm | MQL | Class II | Obstetrics/Gynecology |
| 2025-08-26 | K251305 | Ultra-Fast Vitri; Ultra-Fast Warm | MQL | Class II | Obstetrics/Gynecology |
| 2020-10-23 | K200249 | 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]) | MQL | Class II | Obstetrics/Gynecology |
| 2020-08-25 | K193522 | iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA | MQL | Class II | Obstetrics/Gynecology |
| 2020-08-17 | K192845 | Sperm Freeze, Sperm Fridge | MQL | Class II | Obstetrics/Gynecology |
| 2020-05-01 | K192540 | Kitazato ET Catheters | MQF | Class II | Obstetrics/Gynecology |