Shirakawa Olympus Co., Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 9
- 510(k) Clearances
- 0
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
| Z-0691-2024 | Class II | Model No. CYF-V2, VISERA Cysto-Nephro Videoscope | December 4, 2023 |
| Z-0689-2024 | Class II | Model No. CYF-VH, CYSTO-NEPHRO VIDEOSCOPE | December 4, 2023 |
| Z-0687-2024 | Class II | Model No. BF-XP190, EVIS EXERA III Bronchovideoscope | December 4, 2023 |
| Z-0685-2024 | Class II | Model No. CYF-5R, Cystonephrofiberscope | December 4, 2023 |
| Z-0686-2024 | Class II | Model No. BF-P190, EVIS EXERA III Bronchovideoscope | December 4, 2023 |
| Z-0684-2024 | Class II | Model No. CYF-5, Cystonephrofiberscope | December 4, 2023 |
| Z-0690-2024 | Class II | Model No. CYF-VHR, CYSTO-NEPHRO VIDEOSCOPE | December 4, 2023 |
| Z-0692-2024 | Class II | Model No. CYF-V2R, VISERA Cysto-Nephro Videoscope | December 4, 2023 |
| Z-0688-2024 | Class II | Model No. ENF-XP, RHINO-LARYNGOFIBERSCOPE | December 4, 2023 |