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. Orthopedic ✕

2 devices

1-2 of 2

Cleared Dec 09, 2010

SELF RETAINING SOFT TISSUE RETRACTOR

Orthopedic · 184d

Cleared Nov 05, 2009

Orthopedic · 442d

Data Source

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

Last updated: Sep 17, 2026