Fuji Systems Corp

FDA Filings

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

FDA Registration(s)

• Registration Number: 3000308637
• FEI Number: 3000308637
• Name: FUJI SYSTEMS CORPORATION
• Owner & Operator: FUJI SYSTEMS CORPORATION
• Contact Address: 23-14, HONGO 3-CHOME, BUNKYO-KU --; TOKYO JP-13 Tokyo 113-0033 JP
• US Agent:
  • Gregory J. Geissinger
  • 858 3498839
  • gjgeissinger@hotmail.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Shirakawa Plant 200-2 Aza-Ohira, Odakura, Nishigo; Nishi Shirakawa Gun, Fukushima None of t, 961-8061 JP
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
GUDID 14544050123904 FUJI SYSTEMS CORPORATION	UNIVENT TUBE (TCB TYPE) 1202939	2024-02-08
GUDID 14544050123898 FUJI SYSTEMS CORPORATION	UNIVENT TUBE (TCB TYPE) 1202937	2024-02-08
GUDID 14544050123881 FUJI SYSTEMS CORPORATION	UNIVENT TUBE (TCB TYPE) 1202936	2024-02-08
GUDID 14544050123874 FUJI SYSTEMS CORPORATION	UNIVENT TUBE (TCB TYPE) 1202935	2024-02-08
GUDID 14544050123867 FUJI SYSTEMS CORPORATION	UNIVENT TUBE (TCB TYPE) 1202931	2024-02-08
GUDID 14544050123850 FUJI SYSTEMS CORPORATION	UNIVENT TUBE (TCB TYPE) 1202930	2024-02-08
GUDID 14544050123843 FUJI SYSTEMS CORPORATION	UNIVENT TUBE (TCB TYPE) 1202928	2024-02-08
GUDID 14544050123836 FUJI SYSTEMS CORPORATION	UNIVENT TUBE (TCB TYPE) 1202927	2024-02-08
GUDID 14544050123812 FUJI SYSTEMS CORPORATION	UNIVENT TUBE (TCB TYPE) 1202933	2024-02-08
GUDID 14544050124000 FUJI SYSTEMS CORPORATION	SILBRONCHO (RIGHT LUNG) 1203639	2023-09-13
GUDID 14544050123997 FUJI SYSTEMS CORPORATION	SILBRONCHO (RIGHT LUNG) 1203637	2023-09-13
GUDID 14544050123980 FUJI SYSTEMS CORPORATION	SILBRONCHO (RIGHT LUNG) 1203635	2023-09-13
GUDID 14544050123973 FUJI SYSTEMS CORPORATION	SILBRONCHO (RIGHT LUNG) 1203633	2023-09-13
GUDID 14544050123966 FUJI SYSTEMS CORPORATION	SILBRONCHO (LEFT LUNG) 1203539	2023-09-13
GUDID 14544050123959 FUJI SYSTEMS CORPORATION	SILBRONCHO (LEFT LUNG) 1203537	2023-09-13
GUDID 14544050123942 FUJI SYSTEMS CORPORATION	SILBRONCHO (LEFT LUNG) 1203535	2023-09-13
GUDID 14544050123928 FUJI SYSTEMS CORPORATION	UNIBLOCKER 1203105	2023-09-13
GUDID 14544050123829 FUJI SYSTEMS CORPORATION	UNIVENT TUBE (TCB TYPE) 1202720	2023-09-13
GUDID 14544050123805 FUJI SYSTEMS CORPORATION	UNIVENT TUBE (TCB TYPE) 1202716	2023-09-13
GUDID 04544050123938 FUJI SYSTEMS CORPORATION	SILBRONCHO (LEFT LUNG) 1203533	2023-09-13
GUDID 04544050123914 FUJI SYSTEMS CORPORATION	UNIBLOCKER 1203104	2023-09-11
PMN K223275 Fuji Systems Corporation	CELLO II Balloon Guide Catheter	2022-12-09
GUDID 14544050120743 FUJI SYSTEMS CORPORATION	CELLO™, Balloon Guide Catheter	2022-01-26
GUDID 14544050120736 FUJI SYSTEMS CORPORATION	CELLO™, Balloon Guide Catheter	2022-01-26
GUDID 04544050120722 FUJI SYSTEMS CORPORATION	CELLO™, Balloon Guide Catheter	2022-01-26
GUDID 04544050120715 FUJI SYSTEMS CORPORATION	CELLO™, Balloon Guide Catheter	2022-01-26
GUDID 04544050093491 FUJI SYSTEMS CORPORATION	CELLO™, Balloon Guide Catheter 1510590	2019-01-23
GUDID 04544050093484 FUJI SYSTEMS CORPORATION	CELLO™, Balloon Guide Catheter 1510580	2019-01-23
GUDID 04544050093460 FUJI SYSTEMS CORPORATION	CELLO™, Balloon Guide Catheter 1510570	2019-01-23
GUDID 04544050093446 FUJI SYSTEMS CORPORATION	CELLO™, Balloon Guide Catheter 1510560	2019-01-23
GUDID 04544050056243 FUJI SYSTEMS CORPORATION	FOLEY CATHETER 2-WAY 1210106	2018-09-24
GUDID 04544050083959 FUJI SYSTEMS CORPORATION	SILBRONCHO (RIGHT LUNG) 1203639	2018-07-06
GUDID 04544050083942 FUJI SYSTEMS CORPORATION	SILBRONCHO (RIGHT LUNG) 1203637	2018-07-06
GUDID 04544050083935 FUJI SYSTEMS CORPORATION	SILBRONCHO (RIGHT LUNG) 1203635	2018-07-06
GUDID 04544050083928 FUJI SYSTEMS CORPORATION	SILBRONCHO (RIGHT LUNG) 1203633	2018-07-06
GUDID 04544050080965 FUJI SYSTEMS CORPORATION	UNIBLOCKER 1203104	2018-07-06
GUDID 04544050063715 FUJI SYSTEMS CORPORATION	UNIBLOCKER 1203105	2018-07-06
GUDID 04544050061209 FUJI SYSTEMS CORPORATION	SILBRONCHO (LEFT LUNG) 1203539	2018-07-06
GUDID 04544050061193 FUJI SYSTEMS CORPORATION	SILBRONCHO (LEFT LUNG) 1203537	2018-07-06
GUDID 04544050061186 FUJI SYSTEMS CORPORATION	SILBRONCHO (LEFT LUNG) 1203535	2018-07-06
GUDID 04544050061148 FUJI SYSTEMS CORPORATION	SILBRONCHO (LEFT LUNG) 1203533	2018-07-06
GUDID 04544050056076 FUJI SYSTEMS CORPORATION	UNIVENT TUBE (TCB TYPE) 1202937	2018-07-06
GUDID 04544050056069 FUJI SYSTEMS CORPORATION	UNIVENT TUBE (TCB TYPE) 1202936	2018-07-06
GUDID 04544050056052 FUJI SYSTEMS CORPORATION	UNIVENT TUBE (TCB TYPE) 1202935	2018-07-06
GUDID 04544050056045 FUJI SYSTEMS CORPORATION	UNIVENT TUBE (TCB TYPE) 1202933	2018-07-06
GUDID 04544050056038 FUJI SYSTEMS CORPORATION	UNIVENT TUBE (TCB TYPE) 1202931	2018-07-06
GUDID 04544050056021 FUJI SYSTEMS CORPORATION	UNIVENT TUBE (TCB TYPE) 1202930	2018-07-06
GUDID 04544050056014 FUJI SYSTEMS CORPORATION	UNIVENT TUBE (TCB TYPE) 1202928	2018-07-06
GUDID 04544050056007 FUJI SYSTEMS CORPORATION	UNIVENT TUBE (TCB TYPE) 1202927	2018-07-06
GUDID 04544050055987 FUJI SYSTEMS CORPORATION	UNIVENT TUBE (TCB TYPE) 1202939	2018-07-06
GUDID 04544050055161 FUJI SYSTEMS CORPORATION	UNIVENT TUBE (TCB TYPE) 1202720	2018-07-06
GUDID 04544050055154 FUJI SYSTEMS CORPORATION	UNIVENT TUBE (TCB TYPE) 1202716	2018-07-06
GUDID 04544050082464 FUJI SYSTEMS CORPORATION	ENDOTRACHEAL TUBE, WIRE REINFORCED, WITH CUFF 1200831	2018-03-29
GUDID 04544050081801 FUJI SYSTEMS CORPORATION	ENDOTRACHEAL TUBE, WIRE REINFORCED, WITH CUFF	2018-03-29
GUDID 04544050055789 FUJI SYSTEMS CORPORATION	ENDOTRACHEAL TUBE, WIRE REINFORCED, WITH CUFF 1200824	2018-03-29
PMN K120781 | DQY FUJI SYSTEMS CORPORATION	CELLO Balloon Guide Catheter; 6F, 7F, 8F, 9F	2012-08-21
PMN K120781 FUJI SYSTEMS CORP.	CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH	2012-08-09
PMN K932647 | BTR FUJI SYSTEMS CORPORATION	Pediatric Cuffed And Uncuffed Et Tube; Standard Cuffed and Uncuffed Et Tube	2008-08-26
PMN K894337 | CBI FUJI SYSTEMS CORPORATION	Univent Tube 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm	2008-08-26
PMN K894337 | CBI FUJI SYSTEMS CORPORATION	Silbroncho Double Lumen Tube	2008-08-26
PMN K051522 | CBI FUJI SYSTEMS CORPORATION	Wire Reinforced Endotracheal Tube	2008-08-26
PMN K894883 | EZL FUJI SYSTEMS CORPORATION	Phycon All Silicone Balloon Catheter	2007-11-01
PMN K051522 FUJI SYSTEMS CORP.	SILBRONCHO DOUBLE LUMEN TUBE	2005-08-17

Related Finance Registrations

NCAGE Code	S7709	FUJI SYSTEMS CORPORATION
CAGE Code	S7709	FUJI SYSTEMS CORPORATION

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
202008031020	Singapore,Singapore -> Norfolk, Virginia	ENDOTRACHEAL TUBE	147 CTN
202005182606	Singapore,Singapore -> Norfolk, Virginia	ENDOTRACHEAL TUBE	160 CTN
2020010951964	Tokyo ,Japan -> Los Angeles, California	ENDOTRACHEAL TUBE	114 CTN
2019121414565	Tokyo ,Japan -> Los Angeles, California	ENDOTRACHEAL TUBE	132 CTN
2019121311379	Tokyo ,Japan -> Los Angeles, California	ENDOTRACHEAL TUBE	132 CTN
2019113079487	Tokyo ,Japan -> Los Angeles, California	ENDOTRACHEAL TUBE	132 CTN
2019112912559	Tokyo ,Japan -> Los Angeles, California	ENDOTRACHEAL TUBE	132 CTN
2019091959996	Tokyo ,Japan -> Los Angeles, California	ENDOTRACHEAL TUBE	123 CTN