Ambu A/S - FDA 510(k) Cleared Devices
Recent clearances: 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), Ambu® Virobac II® Exhalation Filter, Ambu® aScope™ 5 Cysto HD (Standard Deflection)
39
Total
39
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ambu A/S Ear, Nose, Throat ✕
13 devices
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