Medical Device Manufacturer · US , Alexandria , VA

Apple, Inc. - FDA 510(k) Cleared Devices

12 submissions · 9 cleared · Since 2018

Official Website

12

Total

9

Cleared

3

Denied

FDA 510(k) Regulatory Record - Apple, Inc. Ear, Nose, Throat ✕

1 devices

1-1 of 1

Not Cleared Sep 12, 2024

Hearing Aid Feature (HAF)

DEN230081 · SCR

Ear, Nose, Throat · 283d

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: May 06, 2026