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 Anesthesiology ✕

7 devices

1-7 of 7

Cleared May 03, 2021

Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable

Anesthesiology · 131d

Cleared Aug 29, 2016

Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu...

Anesthesiology · 329d

Cleared Nov 18, 2011

Anesthesiology · 226d

Cleared Jan 28, 2011

AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC

Anesthesiology · 121d

Cleared Apr 16, 2010

AMBU ASCOPE AND MONITOR

Anesthesiology · 189d

Cleared Dec 23, 2005

AMBU MARK IV RESUSCITATOR

Anesthesiology · 44d

Cleared Dec 20, 2005

AMBU MARK IV BABY RESUSCITATOR

Anesthesiology · 41d