Xomed, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 82
What Xomed, Inc. makes
Xomed, Inc. manufactures medical devices for otolaryngology, sinus surgery, and ear canal reconstruction, including ventilation tubes (Sheppard and silicone types), myringotomy tools, bone conduction hearing aids, ceramic ear canal prosthetics, and surgical instruments like monopolar energized blades and scissors. Their portfolio also includes otologic packing materials, sinus stents, and devices for repairing tympanic membrane perforations, such as the Kartush Patcher and Pope Umbrella Tube.
The company’s devices are classified under FDA categories Class I, Class II, and Unclassified (U), with most submissions recorded in the FDA’s 510(k) registry. Products are listed under U.S. jurisdiction, adhering to FDA regulatory requirements for their respective device classes. The manufacturer operates from the United States.
Catalogue
Search and filter all 82 devicesShowing 1-50 of 82
Frequently asked questions
How many devices does Xomed, Inc. have in the registry?
The registry currently lists 82 devices for Xomed, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Xomed, Inc.'s devices?
Among its 50 most recently registered devices, Xomed, Inc. has devices listed in FDA 510(k) (50 devices).
What risk classes do Xomed, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Xomed, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Xomed, Inc. in the registry?
The most recently registered devices listed for Xomed, Inc. include KARTUSH TM PATCHER, POPE UMBRELLA TUBE, VENTILATION TUBE TEFLON SHEPARD TYPE and MEROGEL OTOLOGIC PACK.