Fujifilm New Development U S A Inc

FDA Filings

This page includes the latest FDA filings for Fujifilm New Development U S A Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3013314365
• FEI Number: 3013314365
• Name: FUJIFILM NEW DEVELOPMENT U.S.A. INC.
• Owner & Operator: Fujifilm New Development U.S.A. Inc.
• Contact Address: 81 Hartwell Ave Suite 300; Lexington MA 02421 US
• Official Correspondent:
  • Aaron Graham
  • x-857-3276208-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 81 Hartwell Avenue Suite 300; Lexington, MA 02421 US
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 00856853006009 FUJIFILM NEW DEVELOPMENT U.S.A., INC.	InterLock Trocar 1001	2020-01-09
GUDID 00856853006047 FUJIFILM NEW DEVELOPMENT U.S.A., INC.	Fujifilm Surgical System	2019-02-21
GUDID 00856853006030 FUJIFILM NEW DEVELOPMENT U.S.A., INC.	Fujifilm Surgical System	2019-02-21
GUDID 00856853006023 FUJIFILM NEW DEVELOPMENT U.S.A., INC.	Fujifilm Surgical System	2019-02-21
GUDID 00856853006016 FUJIFILM NEW DEVELOPMENT U.S.A., INC.	Fujifilm Surgical System	2018-11-08
PMN K180414 | PEA FUJIFILM NEW DEVELOPMENT U.S.A. INC.	FUJIFILM Surgical System	2018-05-29
PMN K180414 | GCT FUJIFILM NEW DEVELOPMENT U.S.A. INC.	FUJIFILM Surgical System	2018-05-29
PMN K180414 | FET FUJIFILM NEW DEVELOPMENT U.S.A. INC.	FUJIFILM Surgical System	2018-05-29
PMN K180414 FUJIFILM New Development U.S.A., Inc.	EPX-4440FN Digital Video Processor With Light Source	2018-05-24
PMN K170084 | GCJ FUJIFILM NEW DEVELOPMENT U.S.A. INC.	InterLock Trocar	2017-03-22
PMN K162836 | GCJ FUJIFILM NEW DEVELOPMENT U.S.A. INC.	FUJIFILM Surgical System	2017-03-22
PMN K162836 FUJIFILM New Development U.S.A., Inc.	FUJIFILM Surgical System	2017-03-13
PMN K170084 FUJIFILM New Development U.S.A., Inc.	InterLock Trocar	2017-03-10

Related Finance Registrations

NCAGE Code	7V8B7	FUJIFILM NEW DEVELOPMENT U.S.A.,!INC.
CAGE Code	7V8B7	FUJIFILM NEW DEVELOPMENT U.S.A., INC.
S.A.M. Registration	7V8B7 [5065629]	FUJIFILM NEW DEVELOPMENT U.S.A., INC.