Medical Device Manufacturer · US , Fort Lauderdale , FL

Orbusneich Medical, Inc. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2011

Recent clearances: Sapphire II PRO, Sapphire NC Plus, SAPPHIRE NC

View 4 510(k) Devices ↓

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Orbusneich Medical, Inc. Cardiovascular ✕

4 devices

1-4 of 4

Cleared Jan 05, 2017

Sapphire II PRO

Cardiovascular · 59d

Cleared Oct 06, 2016

Sapphire NC Plus

Cardiovascular · 62d

Cleared Sep 01, 2011

Cardiovascular · 246d

Cleared Aug 09, 2011

Cardiovascular · 237d