FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

44 results for "FUJIFILM Healthcare Americas Corporation"
25–44 of 44
Search insights Median review: 160d Cleared: 100% Top manufacturer: Fujifilm Corporation Lead specialty: Gastroenterology & Urology
Cleared Dec 15, 2023
EW10-EC02 Endoscopy Support Program
K230751 · QNP
Fujifilm Corporation
Gastroenterology & Urology · 273d
Cleared Dec 13, 2023
Endoscopic Ultrasonic Probe (P2612S-L)
K231666 · ITX
Fujifilm Healthcare Americas Corporation
Radiology · 189d
Cleared Nov 20, 2023
ARIETTA x10
K231941 · IYN
Fujifilm Healthcare Americas Corporation
Radiology · 143d
Cleared Oct 12, 2023
Scenaria View 4.2
K231574 · JAK
Fujifilm Healthcare Americas Corporation
Radiology · 134d
Cleared Sep 15, 2023
Over-tube (TR-1208A)
K230752 · FED
Fujifilm Healthcare Americas Corporation
Gastroenterology & Urology · 182d
Cleared Sep 08, 2023
FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01
K223827 · FDF
Fujifilm Corporation
Gastroenterology & Urology · 261d
Cleared Sep 01, 2023
Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)
K232314 · FDS
Fujifilm Healthcare Americas Corporation
Gastroenterology & Urology · 30d
Cleared Jul 13, 2023
ECHELON Synergy MRI system
K223426 · LNH
Fujifilm Healthcare Corporation
Radiology · 241d
Cleared Jan 27, 2023
FUJIFILM Endoscope Model EI-740D/S
K221551 · FDS
Fujifilm Corporaton
Gastroenterology & Urology · 241d
Cleared Nov 10, 2022
Synapse 3D Base Tools v6.6
K221677 · LLZ
Fujifilm Corporation
Radiology · 154d
Cleared Nov 10, 2022
FUJIFILM Endoscope Model EB-710P
K220957 · EOQ
Fujifilm Corporaton
Ear, Nose, Throat · 223d
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 Jun 01, 2022
FROG Forceps Valve (VAL1-F1-100)
K221264 · ODC
Fujifilm Medwork GmbH
Gastroenterology & Urology · 30d
Cleared May 23, 2022
SCENARIA View
K213829 · JAK
Fujifilm Healthcare Corporation
Radiology · 166d
Cleared Apr 29, 2022
ARIETTA 50
K220295 · IYN
Fujifilm Healthcare Corporation
Radiology · 86d
Cleared Feb 04, 2022
Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI
K220053 · KGE
Fujifilm Corporation
Gastroenterology & Urology · 29d
Cleared Oct 29, 2021
Balloon BS-3
K213195 · FDA
Fujifilm Corporation
Gastroenterology & Urology · 30d
Cleared Oct 07, 2021
OASIS MRI System
K211406 · LNH
Hitachi Healthcare Americas
Radiology · 154d