Koios Medical, Inc.
Koios Medical, Inc. appears in FDA public data with 1 recall, 4 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-0820-2020, Class II) was initiated on December 31, 2019. Its most recent 510(k) clearance was granted on July 2, 2026.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 4
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0820-2020 | Class II | Koios DS Breast <series 1.0>. The device is a software application which assists skilled physicians | December 31, 2019 |