Clarius Mobile Health Corp.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 12
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K253593 | Clarius Ejection Fraction AI | March 2, 2026 |
| K250226 | Clarius Median Nerve AI | May 8, 2025 |
| K243853 | Clarius Prostate AI | April 16, 2025 |
| K233955 | Clarius OB AI | June 14, 2024 |
| K232257 | Clarius Bladder AI | November 13, 2023 |
| K232704 | Clarius Ultrasound Scanner | October 5, 2023 |
| K222406 | Clarius AI | January 23, 2023 |
| K213436 | Clarius Ultrasound Scanner | November 15, 2021 |
| K192107 | Clarius Ultrasound Scanner | August 29, 2019 |
| K180799 | Clarius Ultrasound Scanner | May 14, 2018 |
| K172385 | Clarius Ultrasound System | September 14, 2017 |
| K163138 | Clarius Ultrasound System | November 30, 2016 |