BunkerHill Health
FDA 510(k) & PMA Approved Devices — 8 products
Total Devices8
Categories4
Latest Approval2026-03-06
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K260167 | Bunkerhill Contrast AVC | JAK | 2026-03-06 | View |
| 510(k) | K260166 | Bunkerhill Contrast CAC | JAK | 2026-03-06 | View |
| 510(k) | K250662 | Bunkerhill MAC | JAK | 2025-10-03 | View |
| 510(k) | K250649 | Bunkerhill ECG-EF | QYE | 2025-09-19 | View |
| 510(k) | K243779 | Bunkerhill Abdominal Aortic Quantification (AAQ) | QIH | 2025-07-01 | View |
| 510(k) | K242295 | BunkerHill BMD | KGI | 2025-04-08 | View |
| 510(k) | K243229 | Bunkerhill AVC | JAK | 2025-01-27 | View |
| 510(k) | K240369 | CAC (gated) Algorithm | JAK | 2024-09-27 | View |
No matching devices.