Apple, Inc. - FDA 510(k) Cleared Devices
11
Total
8
Cleared
3
Denied
FDA 510(k) cleared devices by Apple, Inc. Cardiovascular ✕
7 devices
Cleared
Sep 11, 2025
Hypertension Notification Feature (HTNF)
Cardiovascular
202d
Cleared
Jul 21, 2023
Irregular Rhythm Notification Feature (IRNF)
Cardiovascular
87d
Cleared
Jun 03, 2022
Atrial Fibrillation History Feature
Cardiovascular
165d
Cleared
Oct 22, 2021
IRNF App
Cardiovascular
73d
Cleared
Oct 08, 2020
ECG App
Cardiovascular
122d
Not Cleared
Sep 11, 2018
Irregular Rhythm Notification Feature
Cardiovascular
33d
Not Cleared
Sep 11, 2018
ECG App
Cardiovascular
28d