Apple, Inc. - FDA 510(k) Cleared Devices
11
Total
8
Cleared
3
Denied
Apple, Inc. has 8 FDA 510(k) cleared medical devices. Based in Alexandria, US.
Latest FDA clearance: Sep 2025. Active since 2018. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Apple, Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) cleared devices by Apple, Inc.
11 devices
Cleared
Sep 11, 2025
Hypertension Notification Feature (HTNF)
Cardiovascular
202d
Cleared
Jun 23, 2025
Digital Prism Correction Feature (DPCF)
Ophthalmic
157d
Cleared
Oct 21, 2024
Digital Prism Correction Feature (DPCF)
Ophthalmic
98d
Cleared
Sep 13, 2024
Sleep Apnea Notification Feature (SANF)
Anesthesiology
162d
Not Cleared
Sep 12, 2024
Hearing Aid Feature (HAF)
Ear, Nose, Throat
283d
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