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FDA 510(k) Applications Submitted by FUJIFILM Corporaton
FDA 510(k) Number
Submission Date
Device Name
Applicant
K220957
04/01/2022
FUJIFILM Endoscope Model EB-710P
FUJIFILM Corporaton
K200973
04/13/2020
Synapse 3D Cardiac Tools
FUJIFILM Corporaton
K221551
05/31/2022
FUJIFILM Endoscope Model EI-740D/S
FUJIFILM Corporaton
K212950
09/16/2021
FUJIFILM Video Laparoscope EL-R740M30
FUJIFILM Corporaton
K223295
10/26/2022
Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D
FUJIFILM Corporaton
K203717
12/21/2020
Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0
FUJIFILM Corporaton
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