Ambu A/S FDA Approvals

0 new drug approvals and 21 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Ambu® aScope Gastro; Ambu® aScope Gastro Large510(k)Sep 16, 2026Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Sep 16, 2026
Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set510(k)Sep 16, 2026Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Traditional)	Sep 16, 2026
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)510(k)Jul 14, 2026Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jul 14, 2026
Ambu® Virobac II® Exhalation Filter510(k)Apr 30, 2026Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Apr 30, 2026
Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection)510(k)Jun 11, 2025Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Jun 11, 2025
Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection); Ambu® aBox 2510(k)Oct 16, 2024Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Oct 16, 2024
Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection); Ambu® aView 2 Advance510(k)Oct 10, 2024Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Oct 10, 2024
Ambu® aScope 5 Uretero (Standard Deflection); Ambu® aScope 5 Uretero (Reverse Deflection); Ambu® aView 2 Advance510(k)Aug 16, 2024Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Special)	Aug 16, 2024
Ambu® aScope 5 Uretero (Standard Deflection); Ambu® aScope 5 Uretero (Reverse Deflection); Ambu® aBox 2510(k)Jun 24, 2024Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Jun 24, 2024
Ambu® aScope Duodeno 2, Ambu® aBox 2510(k)Apr 16, 2024Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Apr 16, 2024
Ambu® aScope Gastro Large; Ambu® aBox 2510(k)Apr 5, 2024Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Apr 5, 2024
Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aView 2 Advance510(k)Jan 4, 2024Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Special)	Jan 4, 2024
Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set510(k)Sep 20, 2023Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Special)	Sep 20, 2023
Ambu® aScope Colon; Ambu® aBox 2510(k)Sep 15, 2023Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Sep 15, 2023
Ambu® aScope 5 Broncho 2.7/1.2, Ambu® aScope 5 Broncho 4.2/2.2, Ambu® aBox 2510(k)Aug 10, 2023Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Traditional)	Aug 10, 2023
Ambu® aScope 5 Broncho HD 5.0/2.2, Ambu® aScope 5 Broncho HD 5.6/2.8, Ambu® aView 2 Advance510(k)Jun 1, 2023Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Traditional)	Jun 1, 2023
Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler Set510(k)Jan 12, 2023Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Special)	Jan 12, 2023
Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2510(k)Jul 25, 2022Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Traditional)	Jul 25, 2022
Ambu® aScope Gastro, Ambu® aBox2510(k)Feb 3, 2022Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Feb 3, 2022
aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8510(k)Jun 17, 2021Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Special)	Jun 17, 2021
Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable510(k)May 3, 2021Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	May 3, 2021

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