Data / Medical devices / Choledochoscope And Accessories, Flexible/Rigid / Japan
FDA-registered makers of Choledochoscope And Accessories, Flexible/Rigid in Japan: 6 establishments
6 establishments in Japan are registered with the FDA to make Choledochoscope And Accessories, Flexible/Rigid (product code FBN). 6 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Choledochoscope And Accessories, Flexible/Rigid
- Product code
- FBN
- Country
- Japan
Makers of Choledochoscope 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 | 3 | March 10, 2010 | 0 | 0 | 0 | api.fda.gov |
| Aizu Olympus Co., Ltd. | AIZUWAKAMATSU-SHI Fukushima, Japan | Manufacturer | 2 | August 7, 1991 | 0 | 1 | 0 | api.fda.gov |
| AOMORI OLYMPUS CO., LTD. Kuroishi Site | KUROISHI-SHI Aomori, Japan | Manufacturer | 1 | August 7, 1991 | 0 | 0 | 0 | api.fda.gov |
| HOYA Corporation PENTAX Lifecare Division | KURIHARA-SHI Miyagi, Japan | Exporter to the US, Manufacturer | 1 | November 3, 1995 | 0 | 0 | 0 | api.fda.gov |
| HOYA Corporation PENTAX Lifecare Division | Akishima-shi Tokyo, Japan | Complaint file establishment, Specification developer | 1 | November 3, 1995 | 0 | 0 | 0 | api.fda.gov |
| Shirakawa Olympus Co., Ltd. | NISHISHIRAKAWA-GUN Fukushima, Japan | Manufacturer | 1 | March 10, 2010 | 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.