Visby Medical, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Visby Medical, Inc. - FDA 510(k) Cleared Devices
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
Visby Medical, Inc. has 3 FDA 510(k) cleared medical devices. Based in San Jose, US.
Latest FDA clearance: May 2026. Active since 2025. Primary specialty: Microbiology.
Browse the FDA 510(k) cleared devices submitted by Visby Medical, Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Visby Medical, Inc.
4 devices
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
Microbiology
319d
Cleared
Feb 19, 2025
Visby Medical Respiratory Health Test
Microbiology
177d