This page includes the latest FDA filings for Fujifilm Medical Systems U S A Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
Fujifilm Medical Systems U S A Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:
| Registration Number | 3004972322 |
| FEI Number | 3004972322 |
| Name | FUJIFILM Medical Systems U.S.A., Inc. |
| Owner & Operator | FUJIFILM CORPORATION |
| Contact Address | 26-30 NISHIAZABU, 2-CHOME MINATO-KU JP-13 Tokyo 106-8620 JP |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 3020 CARRINGTON MILL BLVD STE 500 Morrisville, NC 27560 US |
| Establishment Type | Manufacture Medical Device |
| Registration Number | 3005625991 |
| FEI Number | 3005625991 |
| Name | FUJIFILM Medical Systems U.S.A., Inc. |
| Owner & Operator | FUJIFILM CORPORATION |
| Contact Address | 26-30 NISHIAZABU, 2-CHOME MINATO-KU JP-13 Tokyo 106-8620 JP |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 1100 King Georges Post Rd Edison, NJ 08837 US |
| Registration Number | 1000513161 |
| FEI Number | 1000513161 |
| Name | Fujifilm Medical Systems U.S.A., Inc |
| Owner & Operator | FUJIFILM CORPORATION |
| Contact Address | 26-30 NISHIAZABU, 2-CHOME MINATO-KU JP-13 Tokyo 106-8620 JP |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 81 Hartwell Avenue, Suite 300 Lexington, MA 02421 US |
| Registration Number | 2431293 |
| FEI Number | 2431293 |
| Name | FUJIFILM Medical Systems U.S.A., Inc. |
| Owner & Operator | FUJIFILM CORPORATION |
| Contact Address | 26-30 NISHIAZABU, 2-CHOME MINATO-KU JP-13 Tokyo 106-8620 JP |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 10 HIGH POINT DR. Wayne, NJ 07470 US |
| Registration Number | 3003991612 |
| FEI Number | 3003991612 |
| Name | Randy Vader |
| Owner & Operator | FUJIFILM Medical Systems U.S.A., Inc. |
| Contact Address | 81 Hartwell Ave, Suite 300 Lexington MA 02421 US |
| Official Correspondent |
|
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 81 Hartwell Avenue, Suite 300 Lexington, MA 02421 US |
| Establishment Type | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Registration Number | 3012206788 |
| FEI Number | 3012206788 |
| Name | FUJIFILM Medical Systems U.S.A., Inc. |
| Owner & Operator | FUJIFILM CORPORATION |
| Contact Address | 26-30 NISHIAZABU, 2-CHOME MINATO-KU JP-13 Tokyo 106-8620 JP |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 6200 Phyllis Dr Cypress, CA 90630 US |
Device Company | Device | Date |
|---|---|---|
| FUJIFILM MEDICAL SYSTEMS U.S.A., INC. | ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option | 2020-09-30 |
| FUJIFILM MEDICAL SYSTEMS U.S.A., INC. | Aspire Cristalle Digital Breast Tomosynthesis Option | 2019-10-25 |
| FUJIFILM MEDICAL SYSTEMS U.S.A., INC. | Synapse Enterprise Viewer | 2019-05-31 |
| FUJIFILM MEDICAL SYSTEMS U.S.A., INC. | Synapse Mobility | 2019-05-29 |
| FUJIFILM MEDICAL SYSTEMS U.S.A., INC. | Synapse MPR Fusion | 2019-05-29 |
| FUJIFILM MEDICAL SYSTEMS U.S.A., INC. | Synapse Cardiology PACS | 2019-05-29 |
| FUJIFILM MEDICAL SYSTEMS U.S.A., INC. | Synapse Radiology PACS | 2019-05-29 |
FUJIFILM Medical Systems U.S.A., Inc. [FUJIFILM CORPORATION] | Synapse Enterprise Viewer Version 1.0 | 2019-05-07 |
FUJIFILM Medical Systems U.S.A., Inc. [FUJIFILM CORPORATION] | Synapse PACS | 2019-03-28 |
| FUJIFILM MEDICAL SYSTEMS U.S.A., INC. | ASPIRE Cristalle Breast Tomosynthesis System | 2019-02-08 |
FUJIFILM Medical Systems U.S.A., Inc. | FUJIFILM Bronchoscope Model EB-530P | 2018-01-19 |
FUJIFILM Medical Systems U.S.A., Inc. | FUJIFILM Ultrasonic Processor SP-900 And FUJIFILM Ultrasonic Probe PB2020-M | 2018-01-11 |
Fujifilm Medical Systems U.S.A., Inc. | ASPIRE Cristalle | 2017-10-27 |
FUJIFILM Medical Systems U.S.A., Inc. | ASPIRE Bellus II | 2017-09-29 |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. | Fujifilm Duodenoscope Model ED-530XT | 2017-07-21 |
FUJIFILM Medical Systems U.S.A., Inc. | Dynamic Visualization II Image Processing Option For The FDX Console (DR-ID300CL Of The DR-ID600) | 2017-06-30 |
FUJIFILM Medical Systems U.S.A., Inc. | FUJIFILM Hood Models DH-28GR, DH-29CR And DH-30CR | 2017-06-15 |
Randy Vader [FUJIFILM Medical Systems U.S.A., Inc.] | WB7025DC Cleaning Brush | 2017-05-26 |
Randy Vader [FUJIFILM Medical Systems U.S.A., Inc.] | WB11003DV Cleaning Brush | 2017-05-26 |
FUJIFILM Medical Systems U.S.A., Inc. | Fujifilm Diathermic Slitter (FlushKnife) | 2017-05-09 |
FUJIFILM Medical Systems U.S.A., Inc. | FDR AQRO (DR-XD 1000) | 2017-04-24 |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. | Synapse 3D Perfusion Analysis | 2017-04-06 |
FUJIFILM Medical Systems U.S.A., Inc. | FDX Console (DR-ID300CL) Software | 2017-03-16 |
| FUJIFILM MEDICAL SYSTEMS U.S.A., INC. | ASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS OPTION | 2017-01-10 |
FUJIFILM Medical Systems U.S.A., Inc. | Fujifilm Endoscope Models EC-600HL And EC-600LS | 2016-10-18 |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. | Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter) | 2016-06-29 |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. | FDR D-EVO Flat Panel Detector System | 2016-04-08 |
FUJIFILM Medical Systems U.S.A., Inc. [FUJIFILM CORPORATION] | Synapse CardioVascular | 2016-04-07 |
FUJIFILM Medical Systems U.S.A., Inc. [FUJIFILM CORPORATION] | Synapse PACS | 2016-03-28 |
FUJIFILM Medical Systems U.S.A., Inc. [FUJIFILM CORPORATION] | Synapse 5 | 2016-03-28 |
FUJIFILM Medical Systems U.S.A., Inc. | Fujifilm Video Colonoscope Model EC-600WL V2 | 2016-02-23 |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. | Synapse PACS | 2016-02-03 |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. | Balloon Controller PB-30 | 2015-12-15 |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. | Fujifilm Double Balloon Endoscopes Models EN-530T And EN-580T | 2015-08-20 |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. | Synapse Cardiovascular | 2015-08-12 |
FUJIFILM Medical Systems U.S.A., Inc. | FUJIFILM Endoscope Models EC-600HL And EC-600LS | 2015-07-06 |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. | FDR D-EVO FLAT PANEL DETECTOR SYSTEM | 2014-10-03 |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. | EPX-4440HD DIGITAL VIDEO PROCESSOR | 2014-08-22 |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. | FUJIFILM 600 SERIES ENDOSCOPES | 2014-01-10 |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. | SYNAPSE 3D COLON ANALYSIS | 2013-01-22 |
FUJIFILM Medical Systems U.S.A., Inc. [FUJIFILM CORPORATION] | Fujifilm Synapse Workstation Software | 2012-08-31 |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. | SYNAPSE 3D NODULE ANALYSIS | 2012-06-01 |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. | WIRELESS/WIRED FDR D-EVO FLAT PANEL DETECTOR | 2011-03-29 |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. | SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS | 2011-03-16 |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. | SYNAPSE 3D CARDIAC TOOLS | 2011-01-31 |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. | FLAT PANEL DETECTOR, MODEL FDR D-EVO | 2010-07-15 |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. | FUJIFILM FCR VIEW, MODEL CR-VW674 | 2008-06-04 |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. | FCR GO PORTABLE DIGITAL X-RAY SYSTEM | 2008-04-18 |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. | FUJI IP CASSETTE TYPE PC | 2007-05-22 |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 2020091185951 | Tokyo ,Japan -> Los Angeles, California | FUJI MEDICAL FILM HS CODE:3701.10 | 390 PCS |
| 2020081523013 | Pusan,South Korea -> New York/Newark Area, Newark, New Jersey | FUJI MEDICAL EQUIPMENT (MAMMOGRAPHY OPTION) HS CODE:9022.90 | 19 PKG |
| 2020062651002 | Tokyo ,Japan -> Los Angeles, California | FUJI MEDICAL FILM HS CODE:3701.10, 3701.30 | 81 PCS |
| 202005237812 | Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New Jersey | MEDICAL EQUIPMENTS | 22 PKG |
| 2020051611407 | Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New Jersey | MEDICAL EQUIPMENTS | 1 PKG |
| 2020051123078 | Pusan,South Korea -> New York/Newark Area, Newark, New Jersey | RADIATION GENERATOR UNITS | 4 CAS |
| 2020051123077 | Pusan,South Korea -> New York/Newark Area, Newark, New Jersey | RADIATION GENERATOR UNITS | 4 CAS |
| 2020050421854 | Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New Jersey | MEDICAL EQUIPMENTS | 3 PKG |