Fujifilm Holdings America Corp

FDA Filings

This page includes the latest FDA filings for Fujifilm Holdings America Corp. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number2022379
FEI Number2022379
NameFUJIFILM IRVINE SCIENTIFIC, INC.
Owner & OperatorFUJIFILM Holdings America Corporation
Contact Address2511 DAIMLER STREET --
Santa Ana CA 92705 US
Official Correspondent
  • Marlin Frechette
  • x-949-2617800-288
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2511 DAIMLER ST
Santa Ana, CA 92705 US
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



FDA Filings

Device
Company
DeviceDate
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Vit Kit - Warm NX2019-07-02
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Vit Kit - Freeze NX2019-07-02
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Sunlight Medical, Inc. Blastomere Biopsy Pipettes, Polar Body Biopsy Pipets2017-11-07
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Sunlight Medical, Inc. ICSI and Spermatid Injection, Holding, Zona Drilling and Dissection, Denuding Pipets2017-11-07
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Arctic Sperm Cryopreservation Medium2017-09-07
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Continuous Single Culture??NX (CSCM?NX)2017-07-25
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Continuous Single Culture??NX Complete (CSCM?NXC)2017-07-25
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Cryolock2015-10-16
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
LIFE4C2014-10-17
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Refrigeration Medium Test Yolk Buffer (TYB) with Gentamicin2014-06-14
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Freezing Medium Test Yolk Buffer (TYB) with Gentamicin2014-06-14
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Modified Ham's F-10 with Human Albumin2014-06-14
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
PBS 1X - Dulbecco's Phosphate Buffered Saline Solution2014-06-14
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
ISolate?2014-06-14
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
ISolate? Sperm Separation Medium2014-06-14
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
ISolate? Sperm Separation Medium Stock Solution2014-06-14
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
ISolate? Sperm Separation Medium Concentrate2014-06-14
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Sperm Maintenance Medium with Glycerol and HSA2014-06-14
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
P-1 Powder w/o Phenol Red2014-06-14
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
P-1 (Preimplantation Stage One) Medium with Gentamicin2014-06-14
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Complete P-1 Medium with Dextran Serum Supplement (DSS) and Gentamicin2014-06-14
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Sperm Washing Medium2014-06-14
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Modified Sperm Washing Medium2014-06-14
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Modified HTF Powder - HEPES (without antibiotics)2014-06-14
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Modified HTF Medium HEPES with Gentamicin2014-06-14
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
HTF Powder (without antibiotics)2014-06-14
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
HTF Powder (without Phenol Red)2014-06-14
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
HTF Medium with Gentamicin2014-06-14
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Human Serum Albumin (HSA)2014-06-14
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Blastocyst Medium2014-06-14
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Serum Substitute Supplement2014-06-14
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Modified Ham's F-102014-06-13
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Modified Ham's F-10 Supplement (50X) Lyophilized2014-06-13
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Modified Ham's F-10 Medium2014-06-13
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Modified Ham's F-10 Basal Medium2014-06-13
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Modified Ham's F-10 Basal Medium HEPES2014-06-13
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Polyvinylpyrrolidone (PVP)2014-06-13
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Polyvinylpyrrolidone (PVP) Lyophilized2014-06-13
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
7% Polyvinylpyrrolidone (PVP)2014-06-13
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
7% Polyvinylpyrrolidone (PVP) Solution with Human Serum Albumin (HSA)2014-06-13
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
10% Polyvinylpyrrolidone (PVP)2014-06-13
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
10% Polyvinylpyrrolidone (PVP) Solution with Human Serum Albumin (HSA)2014-06-13
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Tyrode's Solution, Acidified2014-06-13
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Bovine Serum Albumin (BSA)2014-06-13
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Bovine Serum Albumin (BSA) Powder2014-06-13
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Vit Kit? - Thaw2014-06-13
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Vit Kit? - Freeze2014-06-13
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Single Step Medium2014-06-13
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Continuous Single Culture? with Gentamicin2014-06-13
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Vit Kit? - Thaw2014-06-13
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Vit Kit? - Freeze2014-06-13
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
CryoTip2014-06-13
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
MultiBlast Medium2014-06-13
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Complete MultiBlast Medium with Serum Substitute Supplement (SSS) and Gentamicin2014-06-13
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Complete MultiBlast Medium with Dextran Serum Supplement2014-06-13
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Early Cleavage Medium (ECM)2014-06-13
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Complete Early Cleavage Medium (ECM) with Serum Substitute Supplement (SSS) and Gentamicin2014-06-13
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Complete Early Cleavage Medium (ECM) with Dextran Serum Supplement (DSS) and Gentamicin2014-06-13
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Hyaluronidase Solution2014-06-13
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Embryo Biopsy Medium2014-06-13
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Embryo Thaw Media Kit2014-06-13
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Embryo Freeze Media Kit2014-06-13
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Oil for Embryo Culture2014-06-13
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Water for Assisted Reproductive Technologies (A.R.T.) Use2014-06-13
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Dextran Serum Supplement (DSS)2014-06-13
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Blastocyst Thaw Media Kit2014-06-13
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Blastocyst Freeze Media Kit2014-06-13
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Continuous Single Culture Complete2013-12-03
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Multipurpose Handling Medium2013-12-03
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Multipurpose Handling Medium Complete2013-12-03
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
High-Security Vitrification (HSV) Kit; HSV Straw2011-02-17
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Accessory, Assisted Reproduction - CBS Straw System2011-02-17
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Chang Medium MF1992-12-14
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Chang Medium In Situ1992-12-14
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Chang Medium D1992-12-14
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Chang Medium C1992-12-14
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Chang Medium C Frozen1992-12-14
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Chang Medium Basal1992-12-14
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Chang Medium Basal with Gentamicin1992-12-14
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Chang Medium BMC1992-12-14
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Chang Medium B1992-12-14
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Chang Marrow? Bone Marrow Culture Medium with Gentamicin1992-12-14
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Chang Marrow1992-12-14
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Chang Amnio1992-12-14
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
CHANG MEDIA1992-12-14
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Chang Medium MF1992-12-14
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Chang Medium In Situ1992-12-14
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Chang Medium D1992-12-14
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Chang Medium D (with gentamicin)1992-12-14
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Chang Medium C1992-12-14
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Chang Medium C Kit (lyophilized)1992-12-14
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Chang Medium C Kit (Lyophilized with Gentamicin)1992-12-14
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Chang Medium BMC1992-12-14
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Chang Medium B1992-12-14
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Chang Medium B (with gentamicin)1992-12-14
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Chang Marrow (with gentamicin)1992-12-14
FUJIFILM IRVINE SCIENTIFIC, INC. [FUJIFILM Holdings America Corporation]
Chang Amnio1992-12-14

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020011719745Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina5 PACKAGES PRINTING AND PHOTOGRAPHY ACCESOIRES HS-CODE 84433210 85394900 8443999010 PKG
2020011719745Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina5 PACKAGES PRINTING AND PHOTOGRAPHY ACCESOIRES HS-CODE 84141025 84219990 84433210 8539490010 PKG
2019112156445Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina6 PACKAGES OCE PRODUCTS HS-CODE 84141025,84433210 85394900,842199906 PKG
2019111543520Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina6 PACKAGES OCE PRODUCTS HS-CODE 84141025,84433210 85394900,842199906 PKG
2019111359895Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina6 PACKAGES OCE PRODUCTS HS-CODE 84141025,84433210 85394900,842199906 PKG
2019102246531Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina2 PACKAGES OCE PRODUCTS HS 84433210 . .2 PKG
2019101247165Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina2 PACKAGES OCE PRODUCTS HS 84433210 . .2 PKG
2019101064873Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina2 PACKAGES OCE PRODUCTS HS 84433210 . .2 PKG
2019100960867Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina2 PACKAGES OCE PRODUCTS HS 84433210 . .2 PKG

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