Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

79 results for "Fujifilm Medical Systems U.S.A, Inc."
25–48 of 79
Search insights Median review: 84d Cleared: 100% Top manufacturer: Fujifilm Medical Systems U.S.A, Inc. Lead specialty: Radiology
Cleared May 07, 2019
FUJIFILM Endoscope Model EC-760S-V/L
K190649 · FDF
Fujifilm Corporation
Gastroenterology & Urology · 55d
Cleared Apr 25, 2019
Synapse Enterprise Viewer Version 1.0
K183248 · LLZ
Fujifilm Corporation
Radiology · 155d
Cleared Apr 04, 2019
FUJIFILM Video Bronchoscopes
K182253 · EOQ
Fujifilm Corporation
Ear, Nose, Throat · 227d
Cleared Apr 02, 2019
FUJIFILM Endoscope Model EG-740N
K182836 · FDS
Fujifilm Corporation
Gastroenterology & Urology · 175d
Cleared Mar 28, 2019
FUJIFILM Duodenoscope Model
K181745 · FDT
Fujifilm Corporation
Gastroenterology & Urology · 269d
Cleared Mar 26, 2019
Synapse PACS
K190232 · LLZ
Fujifilm Corporation
Radiology · 48d
Cleared Feb 28, 2019
FUJIFILM Endoscope Model EG-530N
K183686 · FDS
Fujifilm Corporation
Gastroenterology & Urology · 62d
Cleared Feb 27, 2019
FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5
K183683 · FDA
Fujifilm Corporation
Gastroenterology & Urology · 61d
Cleared Feb 22, 2019
FUJIFILM Ultrasonic Endoscope
K182825 · EOQ
Fujifilm Corporation
Ear, Nose, Throat · 141d
Cleared Oct 02, 2018
FUJIFILM Duodenoscope Model
K182051 · FDT
Fujifilm Corporation
Gastroenterology & Urology · 63d
Cleared Sep 25, 2018
Synapse 3D Optional Tools
K181773 · LLZ
Fujifilm Corporation
Radiology · 84d
Cleared Aug 03, 2018
FUJIFILM 600 Series Endoscope EG-600WR v2
K180341 · FDS
Fujifilm Corporation
Gastroenterology & Urology · 177d
Cleared Jul 27, 2018
FUJIFILM Ultrasonic Endoscope
K181763 · FDS
Fujifilm Corporation
Gastroenterology & Urology · 24d
Cleared May 25, 2018
FUJIFILM Endoscopic CO2 Regulator GW-100
K180711 · FCX
Fujifilm Corporation
Gastroenterology & Urology · 67d
Cleared Mar 15, 2018
FUJIFILM Endoscope Models EC-600HL and EC-600LS
K180405 · FDF
Fujifilm Corporation
Gastroenterology & Urology · 29d
Cleared Mar 01, 2018
FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and...
K172916 · FDS
Fujifilm Corporation
Gastroenterology & Urology · 157d
Cleared Jan 19, 2018
FUJIFILM Bronchoscope Model EB-530P
K171291 · EOQ
Fujifilm Medical Systems U.S.A, Inc.
Ear, Nose, Throat · 262d
Cleared Jan 11, 2018
FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M
K171207 · ODG
Fujifilm Medical Systems U.S.A, Inc.
Gastroenterology & Urology · 261d
Cleared Oct 27, 2017
ASPIRE Cristalle
K173132 · MUE
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 28d
Cleared Sep 29, 2017
ASPIRE Bellus II
K171463 · LLZ
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 134d
Cleared Jul 21, 2017
Fujifilm Duodenoscope Model ED-530XT
K152257 · FDT
Fujifilm Medical Systems U.S.A, Inc.
Gastroenterology & Urology · 711d
Cleared Jun 30, 2017
Dynamic Visualization II Image Processing Option for the FDX Console...
K163624 · MQB
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 190d
Cleared Jun 15, 2017
FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR
K162749 · FDS
Fujifilm Medical Systems U.S.A, Inc.
Gastroenterology & Urology · 258d
Cleared May 09, 2017
Fujifilm Diathermic Slitter (FlushKnife)
K171096 · KGE
Fujifilm Medical Systems U.S.A, Inc.
Gastroenterology & Urology · 26d