Medical Device Manufacturer · JP , Ashigara Kami-Gun

Fujifilm Corporation - FDA 510(k) Cleared Devices

65 submissions · 65 cleared · Since 2018
65
Total
65
Cleared
0
Denied
38 devices
26-38 of 38
Cleared Jul 16, 2019
FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L
K183572 · FDS
Gastroenterology & Urology · 207d
Cleared Jun 24, 2019
FUJIFILM Double Balloon Endoscope EI580BT
K183032 · FDA
Gastroenterology & Urology · 235d
Cleared May 07, 2019
FUJIFILM Endoscope Model EC-760S-V/L
K190649 · FDF
Gastroenterology & Urology · 55d
Cleared Apr 02, 2019
FUJIFILM Endoscope Model EG-740N
K182836 · FDS
Gastroenterology & Urology · 175d
Cleared Mar 28, 2019
FUJIFILM Duodenoscope Model
K181745 · FDT
Gastroenterology & Urology · 269d
Cleared Feb 28, 2019
FUJIFILM Endoscope Model EG-530N
K183686 · FDS
Gastroenterology & Urology · 62d
Cleared Feb 27, 2019
FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5
K183683 · FDA
Gastroenterology & Urology · 61d
Cleared Oct 02, 2018
FUJIFILM Duodenoscope Model
K182051 · FDT
Gastroenterology & Urology · 63d
Cleared Aug 03, 2018
FUJIFILM 600 Series Endoscope EG-600WR v2
K180341 · FDS
Gastroenterology & Urology · 177d
Cleared Jul 27, 2018
FUJIFILM Ultrasonic Endoscope
K181763 · FDS
Gastroenterology & Urology · 24d
Cleared May 25, 2018
FUJIFILM Endoscopic CO2 Regulator GW-100
K180711 · FCX
Gastroenterology & Urology · 67d
Cleared Mar 15, 2018
FUJIFILM Endoscope Models EC-600HL and EC-600LS
K180405 · FDF
Gastroenterology & Urology · 29d
Cleared Mar 01, 2018
FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and...
K172916 · FDS
Gastroenterology & Urology · 157d
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