Data / Medical devices / Cystoscope And Accessories, Flexible/Rigid / Japan
FDA-registered makers of Cystoscope And Accessories, Flexible/Rigid in Japan: 6 establishments
6 establishments in Japan are registered with the FDA to make Cystoscope And Accessories, Flexible/Rigid (product code FAJ). 5 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 3, 2026.
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- Device
- Cystoscope And Accessories, Flexible/Rigid
- Product code
- FAJ
- Country
- Japan
Makers of Cystoscope 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 | 2 | January 20, 2023 | 0 | 0 | 0 | api.fda.gov |
| Shirakawa Olympus Co., Ltd. | NISHISHIRAKAWA-GUN Fukushima, Japan | Manufacturer | 2 | January 20, 2023 | 0 | 1 | 0 | api.fda.gov |
| Aizu Olympus Co., Ltd. | AIZUWAKAMATSU-SHI Fukushima, Japan | Manufacturer | 1 | December 29, 2022 | 0 | 1 | 0 | api.fda.gov |
| HOYA Corporation PENTAX Lifecare Division | KURIHARA-SHI Miyagi, Japan | Exporter to the US, Manufacturer | 1 | January 10, 1992 | 0 | 0 | 0 | api.fda.gov |
| HOYA Corporation PENTAX Lifecare Division | Akishima-shi Tokyo, Japan | Complaint file establishment, Specification developer | 1 | January 10, 1992 | 0 | 0 | 0 | api.fda.gov |
| OLYMPUS MEDICAL SYSTEMS CORP. Hinode Plant | NISHITAMA-GUN Tokyo, Japan | 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.