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

71 results for "Fujifilm Corporation"
25–48 of 71
Search insights Median review: 128d Cleared: 100% Top manufacturer: Fujifilm Corporation Lead specialty: Gastroenterology & Urology
Cleared Sep 04, 2024
FUJIFILM Endoscope Model EG-840N
K240142 · FDS
Fujifilm Corporation
Gastroenterology & Urology · 230d
Cleared Dec 15, 2023
EW10-EC02 Endoscopy Support Program
K230751 · QNP
Fujifilm Corporation
Gastroenterology & Urology · 273d
Cleared Sep 08, 2023
FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01
K223827 · FDF
Fujifilm Corporation
Gastroenterology & Urology · 261d
Cleared Nov 10, 2022
Synapse 3D Base Tools v6.6
K221677 · LLZ
Fujifilm Corporation
Radiology · 154d
Cleared Aug 19, 2022
FUJIFILM Ultrasonic Endoscope EG-740UT
K221238 · ODG
Fujifilm Corporation
Gastroenterology & Urology · 112d
Cleared Aug 04, 2022
Endoscope Model EG-580UT and Endoscope Model EG-580UR
K221952 · ODG
Fujifilm Corporation
Gastroenterology & Urology · 30d
Cleared Jun 03, 2022
FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2
K214089 · ODG
Fujifilm Corporation
Radiology · 157d
Cleared May 27, 2022
Aspire Cristalle
K212873 · MUE
Fujifilm Corporation
Radiology · 260d
Cleared Feb 04, 2022
Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI
K220053 · KGE
Fujifilm Corporation
Gastroenterology & Urology · 29d
Cleared Nov 08, 2021
FDR Cross (DR-XD 3000)
K212956 · OWB
Fujifilm Corporation
Radiology · 53d
Cleared Oct 29, 2021
Balloon BS-3
K213195 · FDA
Fujifilm Corporation
Gastroenterology & Urology · 30d
Cleared Aug 19, 2021
Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2
K212296 · FDS
Fujifilm Corporation
Gastroenterology & Urology · 28d
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 20, 2020
FUJIFILM Video Laparoscope
K202130 · GCJ
Fujifilm Corporation
General & Plastic Surgery · 20d
Cleared Jul 06, 2020
Fujifilm Ultrasonic Processor
K200850 · FDS
Fujifilm Corporation
Gastroenterology & Urology · 97d
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