Medical Device Manufacturer · US , San Jose , CA

Visby Medical, Inc. - FDA 510(k) Cleared Devices

3 submissions · 2 cleared · Since 2025
3
Total
2
Cleared
1
Denied
FDA 510(k) Regulatory Record - Visby Medical, Inc. Microbiology ✕
3 devices
1-3 of 3
Cleared Oct 01, 2025
Visby Medical Men's Sexual Health Test
K251501 · QEP
Microbiology · 139d
Not Cleared Mar 28, 2025
Visby Medical Women's Sexual Health Test
DEN240020 · SEA
Microbiology · 319d
Cleared Feb 19, 2025
Visby Medical Respiratory Health Test
K242526 · QOF
Microbiology · 177d
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