Company ยท US
Fujifilm Irvine Scientific, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2019 to 2025. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
4recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 12, 2025 | K250445 | Fast Warm - NX Fujifilm Irvine Scientific | MQL |
| Sep 26, 2024 | K241341 | cryo-GO Vitrification Device Fujifilm Irvine Scientific | MQK |
| Apr 24, 2024 | K233764 | SSS-NX (Serum Substitute Supplement-NX) Fujifilm Irvine Scientific | MQL |
| Nov 9, 2023 | K231804 | PRIME-XV FreezIS DMSO-Free MD Fujifilm Irvine Scientific | NDS |
| Jun 21, 2019 | K190152 | Vit Kit- Freeze NX and Vit Kit- Warm NX Fujifilm Irvine Scientific, Inc. | MQL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 1, 2023 | Fujifilm Irvine Scientific, Inc. Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305 Open, Classified |
MQL | K011938 |
| 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 |