Fujifilm Irvine Scientific, Inc.
FDA Regulatory Profile
Fujifilm Irvine Scientific, Inc. appears in FDA public data with 4 recalls, 5 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0998-2024, Class II) was initiated on November 2, 2023. Its most recent 510(k) clearance was granted on September 12, 2025.
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 5
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0998-2024 | Class II | Sperm separation media are used to separate motile sperm from other constituents of semen. | November 2, 2023 |
| Z-1314-2023 | Class II | Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305 | January 16, 2023 |
| Z-0248-2022 | Class II | Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage | September 8, 2021 |
| Z-0249-2022 | Class II | Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage | September 8, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K250445 | Fast Warm - NX | September 12, 2025 |
| K241341 | cryo-GO Vitrification Device | September 26, 2024 |
| K233764 | SSS-NX (Serum Substitute Supplement-NX) | April 24, 2024 |
| K231804 | PRIME-XV FreezIS DMSO-Free MD | November 9, 2023 |
| K190152 | Vit Kit- Freeze NX and Vit Kit- Warm NX | June 21, 2019 |