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."
49–72 of 79
Search insights Median review: 84d Cleared: 100% Top manufacturer: Fujifilm Medical Systems U.S.A, Inc. Lead specialty: Radiology
Cleared Apr 24, 2017
FDR AQRO (DR-XD 1000)
K170858 · IZL
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 33d
Cleared Apr 06, 2017
Synapse 3D Perfusion Analysis
K162287 · LLZ
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 234d
Cleared Mar 16, 2017
FDX Console (DR-ID300CL) Software
K170451 · LLZ
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 29d
Cleared Oct 18, 2016
Fujifilm Endoscope Models EC-600HL and EC-600LS
K162622 · FDF
Fujifilm Medical Systems U.S.A, Inc.
Gastroenterology & Urology · 28d
Cleared Jun 29, 2016
Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter...
K161186 · KGE
Fujifilm Medical Systems U.S.A, Inc.
Gastroenterology & Urology · 63d
Cleared Apr 08, 2016
FDR D-EVO flat Panel Detector System
K153464 · MQB
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 129d
Cleared Feb 23, 2016
Fujifilm Video Colonoscope Model EC-600WL V2
K160196 · FDF
Fujifilm Medical Systems U.S.A, Inc.
Gastroenterology & Urology · 27d
Cleared Feb 03, 2016
Synapse PACS
K160108 · LLZ
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 15d
Cleared Dec 15, 2015
Balloon controller PB-30
K153483 · FDF
Fujifilm Medical Systems U.S.A, Inc.
Gastroenterology & Urology · 12d
Cleared Aug 20, 2015
Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T
K143556 · FDA
Fujifilm Medical Systems U.S.A, Inc.
Gastroenterology & Urology · 248d
Cleared Aug 12, 2015
Synapse Cardiovascular
K151859 · LLZ
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 35d
Cleared Jul 06, 2015
FUJIFILM Endoscope Models EC-600HL and EC-600LS
K143732 · FDF
Fujifilm Medical Systems U.S.A, Inc.
Gastroenterology & Urology · 189d
Cleared Oct 03, 2014
FDR D-EVO FLAT PANEL DETECTOR SYSTEM
K141765 · MQB
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 94d
Cleared CT Aug 22, 2014
EPX-4440HD DIGITAL VIDEO PROCESSOR
K140149 · PEA
Fujifilm Medical Systems U.S.A, Inc.
Gastroenterology & Urology · 212d
Cleared Mar 25, 2014
ASPIRE CRISTALLE
K133972 · MUE
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 89d
Cleared Jan 10, 2014
FUJIFILM 600 SERIES ENDOSCOPES
K132210 · FDF
Fujifilm Medical Systems U.S.A, Inc.
Gastroenterology & Urology · 178d
Cleared Nov 25, 2013
FDR D-EVO FLAT PANEL DETECTOR SYSTEM
K132509 · MQB
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 105d
Cleared Jan 22, 2013
SYNAPSE 3D COLON ANALYSIS
K123566 · LLZ
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 63d
Cleared Jun 01, 2012
SYNAPSE 3D NODULE ANALYSIS
K120679 · LLZ
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 87d
Cleared Apr 06, 2012
SYNAPSE 3D BASE TOOLS
K120361 · LLZ
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 60d
Cleared Sep 01, 2011
ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM
K110729 · MUE
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 169d
Cleared Mar 29, 2011
WIRELESS/WIRED FDR D-EVO FLAT PANEL DETECTOR
K103596 · MQB
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 111d
Cleared Mar 16, 2011
SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS
K103720 · LLZ
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 85d
Cleared Jan 31, 2011
SYNAPSE 3D CARDIAC TOOLS
K103465 · LLZ
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 68d