Medical Device Manufacturer · US , San Jose , CA

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

4 submissions · 3 cleared · Since 2025

Recent clearances: Visby Medical Flu and COVID-19 Test, Visby Medical Men's Sexual Health Test, Visby Medical Respiratory Health Test

4

Total

3

Cleared

1

Denied

FDA 510(k) Regulatory Record - Visby Medical, Inc. Microbiology ✕

4 devices

1-4 of 4

Cleared May 27, 2026

Visby Medical Flu and COVID-19 Test

Microbiology · 167d

Cleared Oct 01, 2025

Visby Medical Men's Sexual Health Test

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

Microbiology · 177d