Burke, Inc.
United StatesFDA applicant, unverified
Burke, Inc. is a medical device manufacturer, with 47 devices listed in FDA GUDID and FDA 510(k) (FDA Class II and I) as of 15 Nov 2026.
- Devices
- 47
Registry facts
- Registries
- FDA GUDID 40
- FDA 510(k) 7
- Device classes
- FDA Class II 45
- FDA Class I 2
- Identifiers
- DUNS 045093101
What Burke, Inc. makes
Burke, Inc. makes electric-motor-driven wheelchairs that are occupant-controlled, assistive scooters that are electric-motor-driven, alternating-pressure bed mattress overlay systems, bariatric beds, and orthopaedic bed mattresses.
Catalogue
Search and filter all 47 devicesCompany details
- DUNS number
- 045093101
- Phone
- 913-722-5658
Frequently asked questions
How many devices does Burke, Inc. have in the registry?
The registry currently lists 47 devices for Burke, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Burke, Inc.'s devices?
Among its 47 most recently registered devices, Burke, Inc. has devices listed in FDA 510(k) (7 devices) and FDA GUDID (40 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Burke, Inc.'s devices fall under?
Among its 47 most recently registered devices, the classes recorded for Burke, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Burke, Inc. in the registry?
The most recently registered devices listed for Burke, Inc. include Pacesaver Plus III Premier, Scout M-1 350, Pacesaver Plus III Atlas and PaceSaver Fusion 250.