VISBY MEDICAL INC
FDA Regulatory Profile
VISBY MEDICAL INC appears in FDA public data with 1 recall, 6 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-0847-2021, Class II) was initiated on December 5, 2020. Its most recent 510(k) clearance was granted on May 27, 2026.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 6
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0847-2021 | Class II | visby medical COVID-19 Test kit *** An in vitro diagnostic for the qualitative detection of SARS-CoV | December 5, 2020 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K253971 | Visby Medical Flu and COVID-19 Test | May 27, 2026 |
| K251501 | Visby Medical Men's Sexual Health Test | October 1, 2025 |
| DEN240020 | Visby Medical Women's Sexual Health Test | March 28, 2025 |
| K242526 | Visby Medical Respiratory Health Test | February 19, 2025 |
| K220407 | Visby Medical Sexual Health Test | March 7, 2023 |
| K200748 | Visby Medical Sexual Health | August 26, 2021 |