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Fujifilm Medical Systems U.S.A, Inc.

USA · Wayne

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

37listed device types

Class I 7Class II 30Class III 0

plus 133 registration records and 112 510(k), 8 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

14registered devices

Class I 6Class II 8

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States133 registration records, 112 510(k), 8 PMA, 26 excluded

Brazil14 confirmed, 17 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada0 confirmed, 5 excluded

Manufacturer names merged into this page: FUJIFILM Corporation Medical Systems Research & Development Center Kaisei · FUJIFILM Corporation Medical Systems Research & Development Center Kokubunji · FUJIFILM Corporation Medical Systems Research & Development Center Minamiaoyama · FUJIFILM Corporation Medical Systems Research & Development Center Kashiwa · FUJIFILM CORPORATION MEDICAL SYSTEMS RESEARCH & DEVELOPMENT CENTER · FUJIFILM CORPORATION MEDICAL SYSTEMS RESEARCH & DEVELOPMENT CENTER KAISEI

Same-named companies — This database also contains companies with near-identical names: FUJIFILM CORPORATION, MEDICAL SYSTEMS RESEARCH & DEVELOPMENT CENTER, Fujifilm New Development U.S.A., Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

21996

31997

11999

12000

12001

12003

32004

12005

12006

12007

32008

52010

122011

112012

52013

82014

72015

72016

102017

22018

FDA listed device types

showing 8 of 37

Endoscopic Access Overtube, Gastroenterology-Urology 1System, X-Ray, Tomography, Computed 1System, Nuclear Magnetic Resonance Spectroscopic 1Laparoscope, General & Plastic Surgery 1Insufflator, Automatic Carbon-Dioxide For Endoscope 1Coil, Magnetic Resonance, Specialty 1System, Image Processing, Radiological 1Automated Radiological Image Processing Software 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K171291	FUJIFILM Bronchoscope Model EB-530P	2018-01-19
US	K171207	FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M	2018-01-11
US	K173132	ASPIRE Cristalle	2017-10-27
BR	80022069067	Vídeoendoscópio	Class II
BR	10317490199	SU-1 PROCESSADOR DE ULTRASSONS	Class II
BR	80022069065	Endoscópio ultrassônico	Class II

Fujifilm Medical Systems U.S.A, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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