Medical Device Manufacturer · US , Glen Burnie , MD

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

39 submissions · 39 cleared · Since 2005

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)

Official Website

39

Total

39

Cleared

0

Denied

FDA 510(k) Regulatory Record - Ambu A/S Neurology ✕

4 devices

1-4 of 4

Cleared Jul 14, 2026

Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US,...

Neurology · 144d

Cleared Jan 13, 2010

AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE

Neurology · 30d

Cleared Jul 30, 2007

MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE

Neurology · 91d

Cleared May 30, 2007

MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE

Neurology · 30d