Apple, Inc.
FDA 510(k) & PMA Approved Devices — 12 products
Total Devices12
Categories7
Latest Approval2026-04-01
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K253582 | Medical Imaging Calibration Feature (MICF) | SHN | 2026-04-01 | View |
| 510(k) | K250507 | Hypertension Notification Feature (HTNF) | SFR | 2025-09-11 | View |
| 510(k) | K250143 | Digital Prism Correction Feature (DPCF) | SCW | 2025-06-23 | View |
| 510(k) | K242058 | Digital Prism Correction Feature (DPCF) | SCW | 2024-10-21 | View |
| 510(k) | K240929 | Sleep Apnea Notification Feature (SANF) | QZW | 2024-09-13 | View |
| 510(k) | DEN230081 | Hearing Aid Feature (HAF) | SCR | 2024-09-12 | View |
| 510(k) | K231173 | Irregular Rhythm Notification Feature (IRNF) | QDB | 2023-07-21 | View |
| 510(k) | K213971 | Atrial Fibrillation History Feature | QDB | 2022-06-03 | View |
| 510(k) | K212516 | IRNF App | QDB | 2021-10-22 | View |
| 510(k) | K201525 | ECG App | QDA | 2020-10-08 | View |
| 510(k) | DEN180044 | ECG App | QDA | 2018-09-11 | View |
| 510(k) | DEN180042 | Irregular Rhythm Notification Feature | QDB | 2018-09-11 | View |
No matching devices.