Medtronic Xomed, Inc. - FDA 510(k) Cleared Devices

Medtronic Xomed, Inc. is a medical device manufacturer based in Jacksonville, US. The company specializes in ear, nose, and throat surgical devices and related technologies.

Medtronic Xomed has maintained a strong FDA 510(k) regulatory record since 2001. The company has received 37 FDA 510(k) clearances from 37 total submissions, with no denied submissions. The latest clearance was granted in 2026, demonstrating continued active development and market presence in specialized surgical instrumentation.

The company's cleared device portfolio focuses primarily on ear, nose, and throat (ENT) surgical devices, including nerve monitoring systems, endotracheal tubes, surgical probes, sinus dilation systems, and rigid endoscopes. Notable product lines include the NIM Vital Nerve Integrity Monitor and the NuVent Eustachian Tube Dilation Balloon, reflecting expertise in both diagnostic monitoring and minimally invasive surgical solutions.

Explore the complete list of cleared devices, product codes, and clearance dates to review Medtronic Xomed's full regulatory history and device specifications.