Data / Medical devices / Enteroscope And Accessories / Japan
FDA-registered makers of Enteroscope And Accessories in Japan: 10 establishments
10 establishments in Japan are registered with the FDA to make Enteroscope And Accessories (product code FDA). 5 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Enteroscope And Accessories
- Product code
- FDA
- Country
- Japan
Makers of Enteroscope And Accessories in Japan
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| FUJIFILM Corporation Medical Systems Research & Development Center Kaisei | Ashigarakami-Gun Kanagawa, Japan | Complaint file establishment, Manufacturer, Specification developer | 7 | June 13, 2024 | 0 | 0 | 0 | api.fda.gov |
| FUJIFILM Healthcare Manufacturing Corporation Sano Office | Sano City Tochigi, Japan | Contract manufacturer, Manufacturer | 6 | January 11, 2023 | 0 | 0 | 0 | api.fda.gov |
| Aizu Olympus Co., Ltd. | AIZUWAKAMATSU-SHI Fukushima, Japan | Manufacturer | 1 | March 25, 2008 | 0 | 0 | 0 | api.fda.gov |
| Olympus Medical Systems Corp. | HACHIOJI-SHI Tokyo, Japan | Specification developer | 1 | March 25, 2008 | 0 | 0 | 0 | api.fda.gov |
| Shirakawa Olympus Co., Ltd. | NISHISHIRAKAWA-GUN Fukushima, Japan | Manufacturer | 1 | March 25, 2008 | 0 | 0 | 0 | api.fda.gov |
| FUJI SYSTEMS CORPORATION, Shin-Shirakawa Plant | Shirakawa Fukushima, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FUJI SYSTEMS CORPORATION, Shirakawa Plant | Nishi Shirakawa Gun Fukushima, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fujifilm Corporation | ASHIGARAKAMI-GUN Kanagawa, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office | HANAMAKI-SHI Iwate, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tochigichizuka Plant | Chizuka, Tochigi, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.