FUJIFILM Corporation

FDA Filings

This page includes the latest FDA filings for FUJIFILM Corporation. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
FUJIFILM Corporation
FUJIFILM Endoscope Model EC-760Z-V/L2019-11-20
FUJIFILM Corporation
FDR D-EVO III Flat Panel Detector System2019-11-12
Fujifilm Corporation
FDR SE Lite2019-11-01
Fujifilm Corporation
Synapse 3D Blood Flow Analysis2019-10-18
FUJIFILM Corporation
FUJIFILM Duodenoscope Model ED-580XT2019-09-27
FUJIFILM Corporation
FUJIFILM Bronchoscope2019-08-23
FUJIFILM Corporation
FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L And EC-740T/L2019-07-16
FUJIFILM Corporation
Biopsy Positioner2019-07-03
FUJIFILM Corporation
FUJIFILM Double Balloon Endoscope EI580BT2019-06-24
FUJIFILM Irvine Scientific, Inc.
Vit Kit- Freeze NX And Vit Kit- Warm NX2019-06-21
FUJIFILM Corporation
FUJIFILM Endoscope Model EC-760S-V/L2019-05-07
FUJIFILM Corporation
Synapse Enterprise Viewer Version 1.02019-04-25
FUJIFILM Corporation
FUJIFILM Video Bronchoscopes2019-04-04
FUJIFILM Corporation
FUJIFILM Endoscope Model EG-740N2019-04-02
FUJIFILM Corporation
FUJIFILM Duodenoscope Model2019-03-28
FUJIFILM Corporation
Synapse PACS2019-03-26
FUJIFILM SonoSite, Inc.
FUJIFILM Sonosite Vevo MD Imaging System2019-03-15
Fujifilm Corporation
FUJIFILM Endoscope Model EG-530N2019-02-28
FUJIFILM Corporation
FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, And EN-450T52019-02-27
FUJIFILM Corporation
FUJIFILM Ultrasonic Endoscope2019-02-22
FUJIFILM SonoSite, Inc.
SonoSite SII Ultrasound System2019-02-07
FUJIFILM Corporation
FUJIFILM Duodenoscope Model2018-10-02
FUJIFILM Corporation
Synapse 3D Optional Tools2018-09-25
FUJIFILM Corporation
FUJIFILM 600 Series Endoscope EG-600WR V22018-08-03
FUJIFILM Corporation
FUJIFILM Ultrasonic Endoscope2018-07-27
FUJIFILM Corporation
FUJIFILM Endoscopic CO2 Regulator GW-1002018-05-25
FUJIFILM New Development U.S.A., Inc.
EPX-4440FN Digital Video Processor With Light Source2018-05-24
FUJIFILM SonoSite, Inc.
SonoSite IViz Ultrasound System2018-04-13
FUJIFILM Corporation
FUJIFILM Endoscope Models EC-600HL And EC-600LS2018-03-15
Fujifilm Corporation
FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L And EC-760ZP-V/L, And FUJIFILM Water Tank Model WT-6032018-03-01

Latest Premarket Applications

PMAManufacturerDevice NameDate
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
Aspire Cristalle Digital Breast Tomosynthesis Option2019-10-25
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
ASPIRE Cristalle Breast Tomosynthesis System2019-02-08
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
ASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS OPTION2017-01-10

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
FDR AQRO
FUJIFILM CORPORATION2019-11-26
ASPIRE Bellus II
FUJIFILM CORPORATION2019-11-18
SonoSite Edge II
FUJIFILM SONOSITE, INC.2019-11-14
SonoSite Edge II
FUJIFILM SONOSITE, INC.2019-11-14
SonoSite SII
FUJIFILM SONOSITE, INC.2019-11-14
SonoSite SII
FUJIFILM SONOSITE, INC.2019-11-14
SonoSite SII
FUJIFILM SONOSITE, INC.2019-11-14
SonoSite Edge II
FUJIFILM SONOSITE, INC.2019-11-14
SonoSite Edge II
FUJIFILM SONOSITE, INC.2019-11-14
SonoSite SII
FUJIFILM SONOSITE, INC.2019-11-14
SonoSite S-Series
FUJIFILM SONOSITE, INC.2019-11-01
SonoSite S-Series
FUJIFILM SONOSITE, INC.2019-11-01
FUJIFILM
FUJIFILM CORPORATION2019-10-23
FUJIFILM
FUJIFILM CORPORATION2019-10-23
L25V/13-6 MHZ
FUJIFILM SONOSITE, INC.2019-10-11
P17/5-1 MHZ
FUJIFILM SONOSITE, INC.2019-10-11
rP19x/5-1 MHz Armored
FUJIFILM SONOSITE, INC.2019-10-11
FUJIFILM
FUJIFILM CORPORATION2019-10-08
FUJIFILM
FUJIFILM CORPORATION2019-10-08
C35x/8-3 Mhz
FUJIFILM SONOSITE, INC.2019-09-19
C35x/8-3 Mhz
FUJIFILM SONOSITE, INC.2019-09-19
FUJIFILM
FUJIFILM CORPORATION2019-09-17
FUJIFILM
FUJIFILM CORPORATION2019-09-17
Vit Kit - Freeze NX
FUJIFILM IRVINE SCIENTIFIC, INC.2019-07-22
VIT KIT - Warm NX
FUJIFILM IRVINE SCIENTIFIC, INC.2019-07-22
Synapse Enterprise Viewer
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.2019-05-31
Synapse Mobility
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.2019-05-29
Synapse MPR Fusion
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.2019-05-29
Synapse Cardiology PACS
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.2019-05-29
Synapse Radiology PACS
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.2019-05-29
FUJIFILM
FUJIFILM CORPORATION2019-04-30
FUJIFILM
FUJIFILM CORPORATION2019-04-29
FUJI IP CASSETTE CC
FUJIFILM CORPORATION2019-04-23
FUJI IP CASSETTE CC
FUJIFILM CORPORATION2019-04-23
FUJI IP CASSETTE CC
FUJIFILM CORPORATION2019-04-23

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