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 Gastroenterology & Urology ✕
11 devices
Cleared
Jun 11, 2025
Ambu® aScope™ 5 Cysto HD (Standard Deflection)
Gastroenterology & Urology
132d
Cleared
Oct 16, 2024
Ambu® aScope™ 5 Cysto HD (Standard Deflection)
Gastroenterology & Urology
203d
Cleared
Oct 10, 2024
Ambu® aScope™ 5 Cysto HD (Standard Deflection)
Gastroenterology & Urology
197d
Cleared
Aug 16, 2024
Ambu® aScope™ 5 Uretero (Standard Deflection)
Gastroenterology & Urology
29d
Cleared
Jun 24, 2024
Ambu® aScope™ 5 Uretero (Standard Deflection)
Gastroenterology & Urology
224d
Cleared
Apr 16, 2024
Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2
Gastroenterology & Urology
130d
Cleared
Apr 05, 2024
Ambu® aScope™ Gastro Large
Gastroenterology & Urology
199d
Cleared
Sep 15, 2023
Ambu® aScope™ Colon
Gastroenterology & Urology
220d
Cleared
Feb 03, 2022
Ambu® aScope™ Gastro, Ambu® aBox™2
Gastroenterology & Urology
185d
Cleared
Apr 02, 2020
Ambu aScope 4 Cysto
Gastroenterology & Urology
147d
Cleared
Aug 17, 2016
Ambu USR, Ambu M
Gastroenterology & Urology
149d