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."
1–24 of 79
Search insights Median review: 84d Cleared: 100% Top manufacturer: Fujifilm Medical Systems U.S.A, Inc. Lead specialty: Radiology
Cleared Dec 02, 2021
FUJIFILM Video Laparoscope EL-R740M30
K212950 · GCJ
Fujifilm Corporaton
General & Plastic Surgery · 77d
Cleared Nov 08, 2021
FDR Cross (DR-XD 3000)
K212956 · OWB
Fujifilm Corporation
Radiology · 53d
Cleared Sep 10, 2021
JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve
K210625 · ODC
Fujifilm Medwork GmbH
Gastroenterology & Urology · 192d
Cleared Aug 19, 2021
Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2
K212296 · FDS
Fujifilm Corporation
Gastroenterology & Urology · 28d
Cleared Jun 30, 2021
Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0
K203717 · GCJ
Fujifilm Corporaton
General & Plastic Surgery · 191d
Cleared Apr 09, 2021
Endoscope Model EI-740D/S
K210162 · FDS
Fujifilm Corporation
Gastroenterology & Urology · 78d
Cleared Feb 09, 2021
Synapse 3D, Synapse 3D Base Tools v6.1
K203103 · LLZ
Fujifilm Corporation
Radiology · 118d
Cleared Oct 30, 2020
FUJIFILM Distal End Cap
K203028 · FDT
Fujifilm Corporation
Gastroenterology & Urology · 28d
Cleared Aug 27, 2020
Synapse 3D Cardiac Tools
K200973 · LLZ
Fujifilm Corporaton
Radiology · 136d
Cleared Aug 20, 2020
FUJIFILM Video Laparoscope
K202130 · GCJ
Fujifilm Corporation
General & Plastic Surgery · 20d
Cleared May 01, 2020
FUJIFILM EP-6000 Video Processor
K192286 · FET
Fujifilm Corporation
Gastroenterology & Urology · 253d
Cleared Apr 10, 2020
DR-ID 1200SDK System
K200668 · MQB
Fujifilm Corporation
Radiology · 28d
Cleared Feb 20, 2020
Video Laparoscope, Video Processor, Light Source
K192918 · GCJ
Fujifilm Corporation
General & Plastic Surgery · 128d
Cleared Dec 11, 2019
FUJIFILM Distal Cap Models 33-40
K193123 · FDS
Fujifilm Corporation
Gastroenterology & Urology · 29d
Cleared Nov 20, 2019
FUJIFILM Endoscope Model EC-760Z-V/L
K192664 · FDF
Fujifilm Corporation
Gastroenterology & Urology · 56d
Cleared Nov 12, 2019
FDR D-EVO III flat panel detector system
K192932 · MQB
Fujifilm Corporation
Radiology · 26d
Cleared Nov 01, 2019
FDR SE Lite
K192440 · MQB
Fujifilm Corporation
Radiology · 56d
Cleared Oct 18, 2019
Synapse 3D Blood Flow Analysis
K191544 · LLZ
Fujifilm Corporation
Radiology · 129d
Cleared Sep 27, 2019
FUJIFILM Duodenoscope Model ED-580XT
K191747 · FDT
Fujifilm Corporation
Gastroenterology & Urology · 88d
Cleared Sep 05, 2019
FUJIFILM Ultrasonic Endoscope
K183433 · ODG
Fujifilm Corporation
Gastroenterology & Urology · 268d
Cleared Aug 23, 2019
FUJIFILM Bronchoscope
K183607 · EOQ
Fujifilm Corporation
Ear, Nose, Throat · 240d
Cleared Jul 16, 2019
FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L
K183572 · FDS
Fujifilm Corporation
Gastroenterology & Urology · 207d
Cleared Jul 03, 2019
Biopsy Positioner
K191495 · IZH
Fujifilm Corporation
Radiology · 28d
Cleared Jun 24, 2019
FUJIFILM Double Balloon Endoscope EI580BT
K183032 · FDA
Fujifilm Corporation
Gastroenterology & Urology · 235d