Medical Device Manufacturer · US , Echo , OR

Samsung Electronics Co., Ltd. - FDA 510(k) Cleared Devices

43 submissions · 42 cleared · Since 2013

Recent clearances: GC85A, Hearing Aid Feature, Sleep Apnea Feature (v2.0)

Official Website

43

Total

42

Cleared

1

Denied

FDA 510(k) Regulatory Record - Samsung Electronics Co., Ltd. Ear, Nose, Throat ✕

1 devices

1-1 of 1

Cleared CT Jul 31, 2026

Hearing Aid Feature

Ear, Nose, Throat · 112d

Regulatory Intelligence

Linked clinical trials FDA-regulated device evidence

PCCP authorized FDA software change control pathway

Regulatory consultants 510(k) submission support ecosystem

Samsung Research America, Inc.

Mdlab, Inc.

Samsung Research America

Data Source

Sourced from the FDA 510(k) public files . 175,972 total devices indexed.

Last updated: Sep 05, 2026