Shirakawa Olympus Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
9
510(k) Clearances
0
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0691-2024Class IIModel No. CYF-V2, VISERA Cysto-Nephro VideoscopeDecember 4, 2023
Z-0689-2024Class IIModel No. CYF-VH, CYSTO-NEPHRO VIDEOSCOPEDecember 4, 2023
Z-0687-2024Class IIModel No. BF-XP190, EVIS EXERA III BronchovideoscopeDecember 4, 2023
Z-0685-2024Class IIModel No. CYF-5R, CystonephrofiberscopeDecember 4, 2023
Z-0686-2024Class IIModel No. BF-P190, EVIS EXERA III BronchovideoscopeDecember 4, 2023
Z-0684-2024Class IIModel No. CYF-5, CystonephrofiberscopeDecember 4, 2023
Z-0690-2024Class IIModel No. CYF-VHR, CYSTO-NEPHRO VIDEOSCOPEDecember 4, 2023
Z-0692-2024Class IIModel No. CYF-V2R, VISERA Cysto-Nephro VideoscopeDecember 4, 2023
Z-0688-2024Class IIModel No. ENF-XP, RHINO-LARYNGOFIBERSCOPEDecember 4, 2023