FUJIFILM Biosciences Inc.
Santa Ana, CA, US
FUJIFILM Biosciences INC. appears in FDA device records in Santa Ana, CA. FDA records list 45 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to FUJIFILM Biosciences Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Fujifilm Irvine Scientific, Inc.510(k), enforcement report, recall
- Irvine Scientific Sales Co., Inc.510(k), recall
510(k) clearance history
FDA records hold 45 510(k) clearances for FUJIFILM Biosciences Inc. between 1997 and 2025. The busiest year on record is 1999, with 15. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 1 |
| 1999 | 15 |
| 2000 | 2 |
| 2001 | 3 |
| 2002 | 3 |
| 2003 | 1 |
| 2004 | 3 |
| 2006 | 3 |
| 2008 | 3 |
| 2010 | 1 |
| 2012 | 2 |
| 2017 | 3 |
| 2019 | 1 |
| 2023 | 1 |
| 2024 | 2 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250445 | Fast Warm - NX | MQL | Substantially Equivalent | |
| K241341 | cryo-GO Vitrification Device | MQK | Substantially Equivalent | |
| K233764 | SSS-NX (Serum Substitute Supplement-NX) | MQL | Substantially Equivalent | |
| K231804 | PRIME-XV FreezIS DMSO-Free MD | NDS | Substantially Equivalent | |
| K190152 | Vit Kit- Freeze NX and Vit Kit- Warm NX | MQL | Substantially Equivalent | |
| K171224 | Arctic Sperm Cryopreservation Medium | MQL | Substantially Equivalent | |
| K170681 | Continuous Single Culture -NX (CSCM-NX) | MQL | Substantially Equivalent | |
| K170602 | Continuous Single Culture-NX Complete (CSCM-NXC) | MQL | Substantially Equivalent | |
| K121572 | CONTINUOUS SINGLE CULTURE COMPLETE | MQL | Substantially Equivalent | |
| K121128 | MULTIPURPOSE HANDLING MEDIUM | MQL | Substantially Equivalent | |
| K093273 | VIT KIT - FREEZE AND THAW | MQL | Substantially Equivalent | |
| K072609 | SINGLE STEP MEDIUM | MQL | Substantially Equivalent | |
| K072608 | LYOPHILIZED MULTIBLAST MEDIUM KIT | MQL | Substantially Equivalent | |
| K072607 | LYOPHILIZED EARLY CLEAVAGE MEDIUM (ECM) KIT | MQL | Substantially Equivalent | |
| K061549 | AMNIOSTAT-FLM-PG | JHG | Substantially Equivalent | |
| K061679 | WALLACE ARTIFICIAL INSEMINATION CATHETER | LKF | Substantially Equivalent | |
| K060168 | VITRIFICATION FREEZE KIT, VITRIFICATION THAW KIT | MQL | Substantially Equivalent | |
| K041562 | CRYOTIP | MQH | Substantially Equivalent | |
| K034063 | MULTIBLAST MEDIUM | MQL | Substantially Equivalent | |
| K033462 | EARLY CLEAVAGE MEDIUM (ECM) | MQL | Substantially Equivalent | |
| K032887 | PHENOL RED STOCK SOLUTION | MQL | Substantially Equivalent | |
| K022931 | HYALURONIDASE SOLUTION | MQL | Substantially Equivalent | |
| K021358 | EMBRYO BIOPSY MEDIUM | MQL | Substantially Equivalent | |
| K013518 | EMBRYO FREEZE MEDIUM, EMBRYO THAW MEDIUM | MQL | Substantially Equivalent | |
| K011938 | OIL FOR EMBRYO CULTURE | MQL | Substantially Equivalent | |
| K011598 | WATER FOR ASSISTED REPRODUCTIVE TECHNOLOGIES (A.R.T.) USE | MTW | Substantially Equivalent | |
| K003278 | COMPLETE HUMAN TUBAL FLUID (HTF) WITH SERUM SUBSTITUTE SUPPLEMENT, MODEL 9922 | MQL | Substantially Equivalent | |
| K003448 | DEXTRAN SERUM SUPPLEMENT (DSS), MODEL 9301 | MQL | Substantially Equivalent | |
| K000309 | BLASTOCYST FREEZE MEDIUM, BLASTOCYST THAW MEDIUM | MQL | Substantially Equivalent | |
| K991339 | TYRODE'S SOLUTION-ACIDIFIED | MQL | Substantially Equivalent | |
| K991419 | MODIFIED HAM'S F-10 BASAL MEDIUM, MODIFIED HAMS'S F-10 BASAL MEDIUM HEPES, MODIFIED HAM'S F-10 SUPPLEMENT (50X) IYOPHILI | MQL | Substantially Equivalent | |
| K991343 | PVP (POLYVINYLPYRROLIDONE) | MQL | Substantially Equivalent | |
| K991338 | BOVINE SERUM ALBUMIN (BSA) | MQL | Substantially Equivalent | |
| K991342 | PBS 1X- DULBECCO'S PHOSPHATE BUFFERED SALINE SOLUTION | MQL | Substantially Equivalent | |
| K991341 | ISOLATE, ISOLATE CONCENTRATE, ISOLATE STOCK SOLUTION | MQL | Substantially Equivalent | |
| K991337 | SPERM MAINTENANCE MEDIUM WITH GLYCEROL | MQL | Substantially Equivalent | |
| K991421 | FREEZING MEDIUM - TEST YOLK BUFFER (TYB) WITH GLYCEROL, REFRIGERATION MEDIUM - TEST YOLK BUFFER 9TYB) | MQL | Substantially Equivalent | |
| K991420 | MODIFIED HAM'S F-10 WITH ALBUMIN | MQL | Substantially Equivalent | |
| K983588 | SPERM WASHING MEDIUM, MODIFIED SPERM WASHING MEDIUM | MQL | Substantially Equivalent | |
| K983579 | SYNTHETIC SERUM SUBSTITUTE (SSS) | MQL | Substantially Equivalent | |
| K983589 | P-1 (PREIMPLANTATION STAGE ONE) MEDIUM | MQL | Substantially Equivalent | |
| K983586 | HTF MEDIUM, MODIFIED HTF MEDIUM- HEPES, HTF POWDER (WITHOUT ANTIBIOTICS), MODIFIED HTG POWDER- HEPES (WITHOUT ANTIBODITI | MQL | Substantially Equivalent | |
| K983580 | BLASTOCYST MEDIUM | MQL | Substantially Equivalent | |
| K983584 | HUMAN SERUM ALBUMIN (HSA) | MQL | Substantially Equivalent | |
| K971809 | ISOLATE | MQL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2022379 | 2022379 | FUJIFILM Biosciences INC. | 2511 DAIMLER ST, Santa Ana, CA 92705 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LKFCannula, Manipulator/Injector, Uterine
- JHGChromatographic Separation, Lecithin/Sphingomyelin Ratio
- MQKLabware, Assisted Reproduction
- KITMedia And Components, Synthetic Cell And Tissue Culture
- NDSMedia, Culture, Ex Vivo, Tissue And Cell
- MQLMedia, Reproductive
- MQHMicrotools, Assisted Reproduction (Pipettes)
- MTWSystem, Water, Reproduction, Assisted, And Purification
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0998-2024 | Sperm separation media are used to separate motile sperm from other constituents of semen. | 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: 31 December 2024) but incorrectly may contain lower layer (Lot number 9925811106, Shelf Life: 30 November 2023). | Class II | Open, Classified | |
| Z-1314-2023 | Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305 | Due to the detection of oil toxicity in several lots of Oil for Embryo Culture products. | Class II | Open, Classified | |
| Z-0249-2022 | 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 stage embryos. This kit is designed for use with CryoTip (Catalog #40709), and Vitrification Thaw Kit (Vit Kit-Thaw) for optimal recovery of specimens. Vitrification Freeze kit (which includes the VS Vitrification Solution) are cryopreservation media intended for use in the vitrification of oocytes (MII) and pronuclear (PN) zygotes, cleavage stage embryos, and blastocyst stage embryos. Catalog numbers: 90133-SO Vitrification Freeze kit, contained 9x1 mL. Vitrification solution, VS, Catalog #90132. Product form: Liquid. Equilibration Solution-ES is a HEPES buffered solution of Medium-199 containing gentamicin sulfate, 7.5% (v/v) of each DMSO and ethylene glycol and 20% (v/v) Dextran Serum Supplement (DSS). Vitrification Solution-VS is a HEPES buffered solution of Medium-199 containing gentamicin sulfate, 15% (v/v) of each DMSO and ethylene glycol, 20% (v/v) DSS and 0.5 M sucrose. DSS is a protein supplement consisting of 50 mg/mL therapeutic grade Human Serum Albumin (HSA) and 20 mg/mL Dextran. DSS is used at 20% (v/v) in Vit Kit-Freeze for a final concentration of 10 mg/mL HSA and 4 mg/mL Dextran. These two solutions are to be used in sequence according to the step-wise microdrop vitrification protocol. Vitrification Solution-VS Aseptically filtered. Test results reported on C of A Vit Kit -Freeze (Vitrification Freeze Kit) with Gentamycin and DSS Contains 2 x 1 mL Equilibration Solution- ES; 2 X 1 mL Vitrification Solution-VS ...90133-DCOS...RX Only...Sterile ...20YY-MM-DD | Due to a component in kit being labeled with the incorrect Expiration Date | Class II | Open, Classified | |
| Z-0248-2022 | 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 stage embryos. This kit is designed for use with CryoTip (Catalog #40709), and Vitrification Thaw Kit (Vit Kit-Thaw) for optimal recovery of specimens. Vitrification Freeze kit (which includes the VS Vitrification Solution) are cryopreservation media intended for use in the vitrification of oocytes (MII) and pronuclear (PN) zygotes, cleavage stage embryos, and blastocyst stage embryos. Catalog numbers: 90133-DCOS Vitrification Freeze kit, contained 9x1 mL. Vitrification solution, VS, Catalog #90132. Product form: Liquid. Equilibration Solution-ES is a HEPES buffered solution of Medium-199 containing gentamicin sulfate, 7.5% (v/v) of each DMSO and ethylene glycol and 20% (v/v) Dextran Serum Supplement (DSS). Vitrification Solution-VS is a HEPES buffered solution of Medium-199 containing gentamicin sulfate, 15% (v/v) of each DMSO and ethylene glycol, 20% (v/v) DSS and 0.5 M sucrose. DSS is a protein supplement consisting of 50 mg/mL therapeutic grade Human Serum Albumin (HSA) and 20 mg/mL Dextran. DSS is used at 20% (v/v) in Vit Kit-Freeze for a final concentration of 10 mg/mL HSA and 4 mg/mL Dextran. These two solutions are to be used in sequence according to the step-wise microdrop vitrification protocol. Vitrification Solution-VS Aseptically filtered. Test results reported on C of A Vit Kit -Freeze (Vitrification Freeze Kit) with Gentamycin and DSS Contains 9 x 1 mL Equilibration Solution- ES; 9 X 1 mL Vitrification Solution-VS ...90133-DCOS...RX Only...Sterile ...20YY-MM-DD | Due to a component in kit being labeled with the incorrect Expiration Date | Class II | Open, Classified | |
| Z-0593-2009 | Wallace Oocyte Recovery Needles,Oocyte Recovery sets, 750 mm tube with flushing connector, Product Number: KLN-750, and KLN-750. Retrieval of Oocytes. | Smiths Medical International became aware that certain lots of Wallace oocyte Recovery Sets have a damaged needle tip. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain