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

Ambu A/S, is a global medical device company specializing in single-use endoscopy and airway management solutions. The company operates with a manufacturing facility in Glen Burnie, Maryland, and serves hospitals and emergency care settings worldwide. Ambu created the single-use endoscopy market in 2009 and remains the market leader in this category.

Ambu has received 38 FDA 510(k) clearances from 38 total submissions, with no denied submissions on record. The company's regulatory activity spans from 2005 to 2026, demonstrating sustained innovation and market presence. Recent clearances focus on Ear, Nose, and Throat (ENT) devices, including advanced bronchoscopes, rhinolaryngoscopes, and visualization systems for pulmonology and airway management procedures.

Ambu's cleared device portfolio encompasses single-use flexible endoscopes for bronchoscopy, laryngoscopy, and gastroenterology; video laryngoscopes for airway management; patient monitoring electrodes for neurology and cardiology; and resuscitation equipment. The company's aScope and aView product lines represent core innovations in sterile, single-use endoscopic visualization.

Explore the complete list of Ambu's FDA 510(k) cleared devices, including product names, device codes, and clearance dates in the database.

510(k) submissions have been managed by Ambu, Inc. as regulatory consultant.