Durden Enterprises, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 4
What Durden Enterprises, Inc. makes
Durden Enterprises, Inc. manufactures the NeuroWave System 2, a device for neurological monitoring, along with disposable surface EEG electrodes for electroencephalogram recordings. The company also produces wound care products, including wedge pressure dressings and butterfly dressings for minor skin injuries.
The portfolio includes Class I and Class II devices, with some classified as unclassified (U), and these products are listed under the FDA’s 510(k) clearance process. The company is based in the United States.
Catalogue
Neurowave System 2 Ref K883557
510(k) 510(k)Electrode, Surface Eeg Electrode Ref K842271
510(k) 510(k)Wedge Pressure Dressing Ref K891189
510(k) 510(k)Butterfly Dressing Ref K912160
510(k) 510(k)
Frequently asked questions
How many devices does Durden Enterprises, Inc. have in the registry?
The registry currently lists 4 devices for Durden Enterprises, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Durden Enterprises, Inc.'s devices?
Among its 4 most recently registered devices, Durden Enterprises, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Durden Enterprises, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Durden Enterprises, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Durden Enterprises, Inc. in the registry?
The most recently registered devices listed for Durden Enterprises, Inc. include NEUROWAVE SYSTEM 2, ELECTRODE, SURFACE EEG ELECTRODE, WEDGE PRESSURE DRESSING and BUTTERFLY DRESSING.