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"
1–24 of 71
Search insights Median review: 128d Cleared: 100% Top manufacturer: Fujifilm Corporation Lead specialty: Gastroenterology & Urology
Cleared Oct 09, 2026
ECHELON Synergy
K262902 · LNH
Fujifilm Corporation
Radiology · 52d
Cleared Sep 18, 2026
SCENARIA View Phase 6.0
K261229 · JAK
Fujifilm Corporation
Radiology · 156d
Cleared Sep 16, 2026
APERTO Lucent MRI System
K261283 · LNH
Fujifilm Corporation
Radiology · 152d
Cleared Sep 04, 2026
FCT iStream Phase 2
K253836 · JAK
Fujifilm Corporation
Radiology · 277d
Cleared Aug 12, 2026
BA-004CC
K261170 · ITX
Fujifilm Corporation
Radiology · 125d
Cleared Aug 07, 2026
EW10-EC02 Endoscopy Support Program
K260567 · QNP
Fujifilm Corporation
Gastroenterology & Urology · 169d
Cleared Jul 02, 2026
FUJIFILM Processor EP-8000
K261880 · FET
Fujifilm Corporation
Gastroenterology & Urology · 27d
Cleared Jun 16, 2026
FUJIFILM Endoscope Model EB-840S
K253137 · EOQ
Fujifilm Corporation
Ear, Nose, Throat · 264d
Cleared May 27, 2026
Synapse Lung Nodule AI
K254075 · OEB
Fujifilm Corporation
Radiology · 160d
Cleared Apr 30, 2026
Synapse 3D Base Tools (V7.2)
K254189 · QIH
Fujifilm Corporation
Radiology · 128d
Cleared Apr 06, 2026
APERTO Lucent MRI System
K253862 · LNH
Fujifilm Corporation
Radiology · 124d
Cleared Mar 09, 2026
FUJIFILM Endoscope Model ED-S100TP
K251861 · FDT
Fujifilm Corporation
Gastroenterology & Urology · 265d
Cleared Feb 17, 2026
FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit
K250550 · FDS
Fujifilm Corporation
Gastroenterology & Urology · 357d
Cleared Feb 06, 2026
Hood DH-084STR
K253568 · FDS
Fujifilm Corporation
Gastroenterology & Urology · 81d
Cleared Dec 12, 2025
FUJIFILM Ultrasonic Endoscope EB-710US
K250863 · EOQ
Fujifilm Corporation
Ear, Nose, Throat · 266d
Cleared Sep 17, 2025
ECHELON Synergy
K251386 · LNH
Fujifilm Corporation
Radiology · 135d
Cleared Jun 13, 2025
FUJIFILM Endoscope Model EB-710P
K244017 · EOQ
Fujifilm Corporation
Ear, Nose, Throat · 168d
Cleared Jun 10, 2025
FUJIFILM Endoscope Model EG-840N
K243512 · FDS
Fujifilm Corporation
Gastroenterology & Urology · 210d
Cleared May 23, 2025
FUJIFILM Endoscope Model EC-860P/M
K243261 · FDF
Fujifilm Corporation
Gastroenterology & Urology · 220d
Cleared May 21, 2025
Synapse 3D Base Tools (V7.0)
K243762 · QIH
Fujifilm Corporation
Radiology · 166d
Cleared May 20, 2025
SCENARIA View Phase 5.0
K250370 · JAK
Fujifilm Corporation
Radiology · 99d
Cleared Apr 11, 2025
FUJIFILM Processor EP-8000
K243260 · FET
Fujifilm Corporation
Gastroenterology & Urology · 178d
Cleared Nov 01, 2024
Over-tube (TR-1108A)
K243091 · FED
Fujifilm Corporation
Gastroenterology & Urology · 32d
Cleared Oct 11, 2024
Hood (DH-083ST)
K242779 · FDS
Fujifilm Corporation
Gastroenterology & Urology · 28d