Medical Device Manufacturer · US , Glen Burnie , MD

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

41 submissions · 41 cleared · Since 2005

Recent clearances: Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ Gastro, Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)

View 41 510(k) Devices ↓ Official Website

41

Total

41

Cleared

0

Denied

FDA 510(k) Regulatory Record - 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