Xomed-Treace, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 12
What Xomed-Treace, Inc. makes
Xomed-Treace, Inc. manufactures surgical and diagnostic tools for otolaryngology, neurosurgery, and anesthesia, including nerve monitoring devices like the Nerve Integrity Monitor-2 (NIM-2 XL), footpedal suction controls, disposable endoscope light sources, and air drills. Their portfolio also includes ventilation tubes for tympanostomy, rigid rod lens endoscopes, endotracheal tubes with EMG capabilities, and accessories like endoscope sheaths and ventilation tubes. Specialized systems such as the BlackStar™ Star System are designed for precise surgical visualization and support.
The company’s devices are classified under FDA regulations as Class I and Class II, with most requiring 510(k) clearance. Products are listed in the FDA’s 510(k) registry, reflecting their regulatory authorization status. The manufacturer operates from the United States.
Catalogue
Search and filter all 12 devicesFrequently asked questions
How many devices does Xomed-Treace, Inc. have in the registry?
The registry currently lists 12 devices for Xomed-Treace, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Xomed-Treace, Inc.'s devices?
Among its 12 most recently registered devices, Xomed-Treace, Inc. has devices listed in FDA 510(k) (12 devices).
What risk classes do Xomed-Treace, Inc.'s devices fall under?
Among its 12 most recently registered devices, the classes recorded for Xomed-Treace, 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-Treace, Inc. in the registry?
The most recently registered devices listed for Xomed-Treace, Inc. include NERVE INTEGRITY MONITOR-2 (NIM-2 XL), XOMED-TREACE POSITROL FOOTPEDAL SUCTION CONTROL, BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE and X-T AIR DRILL.