Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in CanadaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Clarius Mobile Health with 12 510(k) clearances and 12 AI-enabled devices. The most recent is a 510(k) clearance dated Mar 2, 2026: Clarius Ejection Fraction AI.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Mar 2, 2026 | Clarius Ejection Fraction AIK253593 · QIH | 510(k) clearances |
| Mar 2, 2026 | Clarius Ejection Fraction AIK253593 · Radiology | AI-enabled devices |
| May 8, 2025 | Clarius Median Nerve AIK250226 · QIH | 510(k) clearances |
| May 8, 2025 | Clarius Median Nerve AIK250226 · Radiology | AI-enabled devices |
| Apr 16, 2025 | Clarius Prostate AIK243853 · QIH | 510(k) clearances |
| Apr 16, 2025 | Clarius Prostate AIK243853 · Radiology | AI-enabled devices |
| Jun 14, 2024 | Clarius OB AIK233955 · IYN | 510(k) clearances |
| Jun 14, 2024 | Clarius OB AIK233955 · Radiology | AI-enabled devices |
| Nov 13, 2023 | Clarius Bladder AIK232257 · QIH | 510(k) clearances |
| Nov 13, 2023 | Clarius Bladder AIK232257 · Radiology | AI-enabled devices |
| Oct 5, 2023 | Clarius Ultrasound ScannerK232704 · IYN | 510(k) clearances |
| Oct 5, 2023 | Clarius Ultrasound ScannerK232704 · Radiology | AI-enabled devices |
| Jan 23, 2023 | Clarius AIK222406 · QIH | 510(k) clearances |
| Jan 23, 2023 | Clarius AIK222406 · Radiology | AI-enabled devices |
| Nov 15, 2021 | Clarius Ultrasound ScannerK213436 · IYN | 510(k) clearances |
| Nov 15, 2021 | Clarius Ultrasound ScannerK213436 · Radiology | AI-enabled devices |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
