Ambu, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 33
What Ambu, Inc. makes
Ambu, Inc. manufactures single-use and reusable medical devices for emergency resuscitation, patient monitoring, and airway management. Their portfolio includes resuscitation bags for adults, infants, and neonates, suction pumps, ECG electrodes, and CPAP systems. They also produce wound care dressings, pressure manometers, and specialized accessories like ground pads for defibrillators.
The company’s devices are classified under FDA categories Class I, Class II, Class III, and Unclassified (U), with many authorised via the 510(k) pathway. Their products are listed in the FDA’s 510(k) database, and the company operates from the United States.
Catalogue
Search and filter all 33 devicesFrequently asked questions
How many devices does Ambu, Inc. have in the registry?
The registry currently lists 33 devices for Ambu, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ambu, Inc.'s devices?
Among its 33 most recently registered devices, Ambu, Inc. has devices listed in FDA 510(k) (33 devices).
What risk classes do Ambu, Inc.'s devices fall under?
Among its 33 most recently registered devices, the classes recorded for Ambu, Inc.'s devices are Class I, Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Ambu, Inc. in the registry?
The most recently registered devices listed for Ambu, Inc. include AMBU NEUROLINE GROUND, AMBU MEDIBAG ADULT, AMBU MEDIBAG INFANT/CHILD, AMBU SILICONE RESUSCITATOR, ADULT W/OPEN RESERVOIR and AMBU HAND POWER SUCTION PUMP.