Medical Device Manufacturer · US , Glen Burnie , MD

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

38 submissions · 38 cleared · Since 2005

Recent clearances: Ambu® Virobac II® Exhalation Filter, Ambu® aScope™ 5 Cysto HD (Standard Deflection), Ambu® aScope™ 5 Cysto HD (Standard Deflection)

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38

Total

38

Cleared

0

Denied

FDA 510(k) Regulatory Record - Ambu A/S Ear, Nose, Throat ✕

13 devices

1-12 of 13

Cleared Jan 04, 2024

Ambu® aScope™ 5 Broncho 4.2/2.2

Ear, Nose, Throat · 50d

Cleared Sep 20, 2023

Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set

Ear, Nose, Throat · 26d

Cleared Aug 10, 2023

Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2

Ear, Nose, Throat · 174d

Cleared Jun 01, 2023

Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu®...

Ear, Nose, Throat · 217d

Cleared Jan 12, 2023

Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD...

Ear, Nose, Throat · 27d

Cleared Jul 25, 2022

Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2

Ear, Nose, Throat · 145d

Cleared Jun 17, 2021

aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler...

Ear, Nose, Throat · 84d

Cleared Jul 12, 2019

Ambu aScope 4 RhinoLaryngo Intervention

Ear, Nose, Throat · 88d

Cleared May 22, 2019

Ambu aScope 4 RhinoLaryngo Slim

Ear, Nose, Throat · 28d

Cleared Nov 30, 2018

Ambu aScope RLS Slim

Ear, Nose, Throat · 198d

Cleared Mar 28, 2018

Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2

Ear, Nose, Throat · 113d

Cleared Sep 01, 2016

Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3...

Ear, Nose, Throat · 77d