Medical Device Manufacturer · US , Stamford , CT

Fujifilm Medical Systems U.S.A, Inc. - FDA 510(k) Cleared Devices

39 submissions · 39 cleared · Since 2005

39

Total

39

Cleared

0

Denied

FDA 510(k) Regulatory Record - Fujifilm Medical Systems U.S.A, Inc. Gastroenterology & Urology ✕

12 devices

1-12 of 12

Cleared Jan 11, 2018

FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M

Gastroenterology & Urology · 261d

Cleared Jul 21, 2017

Fujifilm Duodenoscope Model ED-530XT

Gastroenterology & Urology · 711d

Cleared Jun 15, 2017

FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR

Gastroenterology & Urology · 258d

Cleared May 09, 2017

Fujifilm Diathermic Slitter (FlushKnife)

Gastroenterology & Urology · 26d

Cleared Oct 18, 2016

Fujifilm Endoscope Models EC-600HL and EC-600LS

Gastroenterology & Urology · 28d

Cleared Jun 29, 2016

Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter...

Gastroenterology & Urology · 63d

Cleared Feb 23, 2016

Fujifilm Video Colonoscope Model EC-600WL V2

Gastroenterology & Urology · 27d

Cleared Dec 15, 2015

Balloon controller PB-30

Gastroenterology & Urology · 12d

Cleared Aug 20, 2015

Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T

Gastroenterology & Urology · 248d

Cleared Jul 06, 2015

FUJIFILM Endoscope Models EC-600HL and EC-600LS

Gastroenterology & Urology · 189d

Cleared Aug 22, 2014

EPX-4440HD DIGITAL VIDEO PROCESSOR

Gastroenterology & Urology · 212d

Cleared Jan 10, 2014

FUJIFILM 600 SERIES ENDOSCOPES

Gastroenterology & Urology · 178d