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 Ear, Nose, Throat

13 devices
1-13 of 13
Cleared Jan 04, 2024
Ambu® aScope™ 5 Broncho 4.2/2.2
K233671 · EOQ
Ear, Nose, Throat · 50d
Cleared Sep 20, 2023
Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set
K232582 · EOQ
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
K230428 · EOQ
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®...
K223299 · EOQ
Ear, Nose, Throat · 217d
Cleared Jan 12, 2023
Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD...
K223782 · EOQ
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
K220606 · EOQ
Ear, Nose, Throat · 145d
Cleared Jun 17, 2021
aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler...
K210883 · EOQ
Ear, Nose, Throat · 84d
Cleared Jul 12, 2019
Ambu aScope 4 RhinoLaryngo Intervention
K190972 · EOB
Ear, Nose, Throat · 88d
Cleared May 22, 2019
Ambu aScope 4 RhinoLaryngo Slim
K191080 · EOB
Ear, Nose, Throat · 28d
Cleared Nov 30, 2018
Ambu aScope RLS Slim
K181286 · EOB
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
K173727 · EOQ
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...
K161656 · EOQ
Ear, Nose, Throat · 77d
Cleared Nov 01, 2013
AMBU ASCOPE 3 5.0/2.2
K130845 · EOQ
Ear, Nose, Throat · 220d
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