Medical Device Manufacturer · US , Moorepark , CA

Koros USA, Inc. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2007

Recent clearances: DILATOR TUBE SET, SELF RETAINING SOFT TISSUE RETRACTOR, PECTUS STRUT

View 4 510(k) Devices ↓

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Koros USA, Inc. Neurology ✕

2 devices

1-2 of 2

Cleared May 07, 2013

DILATOR TUBE SET

Neurology · 434d

Cleared May 29, 2007

FLEX ARM RETRACTOR SYSTEM

Neurology · 15d

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Sep 17, 2026