Data / Medical devices / Duodenoscope And Accessories, Flexible/Rigid / Japan
FDA-registered makers of Duodenoscope And Accessories, Flexible/Rigid in Japan: 9 establishments
9 establishments in Japan are registered with the FDA to make Duodenoscope And Accessories, Flexible/Rigid (product code FDT). 7 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- Duodenoscope And Accessories, Flexible/Rigid
- Product code
- FDT
- Country
- Japan
Makers of Duodenoscope And Accessories, Flexible/Rigid in Japan
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Olympus Medical Systems Corp. | HACHIOJI-SHI Tokyo, Japan | Specification developer | 9 | February 22, 2026 | 0 | 0 | 0 | api.fda.gov |
| Aizu Olympus Co., Ltd. | AIZUWAKAMATSU-SHI Fukushima, Japan | Manufacturer | 8 | September 19, 2025 | 0 | 0 | 0 | api.fda.gov |
| HOYA Corporation PENTAX Lifecare Division | KURIHARA-SHI Miyagi, Japan | Exporter to the US, Manufacturer | 5 | August 1, 2024 | 0 | 0 | 0 | api.fda.gov |
| HOYA Corporation PENTAX Lifecare Division | Akishima-shi Tokyo, Japan | Complaint file establishment, Specification developer | 5 | August 1, 2024 | 0 | 0 | 0 | api.fda.gov |
| FUJIFILM Corporation Medical Systems Research & Development Center Kaisei | Ashigarakami-Gun Kanagawa, Japan | Manufacturer, Specification developer | 4 | March 9, 2026 | 0 | 0 | 0 | api.fda.gov |
| FUJIFILM Healthcare Manufacturing Corporation Sano Office | Sano City Tochigi, Japan | Manufacturer | 3 | March 9, 2026 | 0 | 0 | 0 | api.fda.gov |
| OLYMPUS MEDICAL SYSTEMS CORP. Hinode Plant | NISHITAMA-GUN Tokyo, Japan | Manufacturer | 2 | February 22, 2026 | 0 | 0 | 0 | api.fda.gov |
| Yoshikawa Kasei Co., Ltd. Medical Company Osaka Plant | Osaka-shi, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yoshikawa Kasei Co., Ltd. Medical Company Shizuoka Plant | Fukuroi City Shizuoka, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.