Medical Device Manufacturer · US , Glen Burnie , MD

Ambu A/S - FDA 510(k) Cleared Devices

37 submissions · 37 cleared · Since 2005

37

Total

37

Cleared

0

Denied

FDA 510(k) cleared devices by Ambu A/S Cardiovascular ✕

3 devices

1-3 of 3

Cleared Jun 11, 2010

AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X

Cardiovascular · 143d

Cleared Oct 25, 2006

AMBU WHITE SENSOR CFM, CFL

Cardiovascular · 370d

Cleared Oct 25, 2006

AMBU BLUE SENSOR NEO AND NEO X

Cardiovascular · 309d