Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA files no records under this name; these are its 8 companies' records, each linked to the record.
As of Nov 15, 2026, FDA's public records list FUJIFILM Holdings and its 8 subsidiaries with 171 510(k) clearances and 39 device recalls. The most recent is a 510(k) clearance dated Jan 27, 2023: FUJIFILM Endoscope Model EI-740D/S.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, FUJIFILM Holdings and its 8 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jan 27, 2023 | FUJIFILM Endoscope Model EI-740D/SK221551 · FDS | 510(k) clearances |
| Jan 11, 2023 | Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500DK223295 · FDA | 510(k) clearances |
| Nov 10, 2022 | FUJIFILM Endoscope Model EB-710PK220957 · EOQ | 510(k) clearances |
| Jun 1, 2022 | FROG Forceps Valve (VAL1-F1-100)K221264 · ODC | 510(k) clearances |
| Dec 2, 2021 | FUJIFILM Video Laparoscope EL-R740M30K212950 · GCJ | 510(k) clearances |
| Sep 10, 2021 | JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps ValveK210625 · ODC | 510(k) clearances |
| Jun 30, 2021 | Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0K203717 · GCJ | 510(k) clearances |
| Aug 27, 2020 | Synapse 3D Cardiac ToolsK200973 · LLZ | 510(k) clearances |
| Jul 31, 2013 | Fujinon/Fujifilm Ultrasonic Endoscope Intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestClass II · A limited number of endoscopes were shipped to FMSU-ESD with a manufacturing defect which included missing set screws us | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built