Data / Medical devices / System, Ablation, Microwave And Accessories / United States
FDA-registered makers of System, Ablation, Microwave And Accessories in the United States: 17 establishments
17 establishments in the United States are registered with the FDA to make System, Ablation, Microwave And Accessories (product code NEY). 11 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Device
- System, Ablation, Microwave And Accessories
- Product code
- NEY
- Country
- United States
Makers of System, Ablation, Microwave And Accessories in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Angiodynamics, Inc | Glens Falls, NY, United States | Manufacturer | 5 | March 27, 2023 | 0 | 1 | 0 | api.fda.gov |
| Angiodynamics, Inc. | Queensbury, NY, United States | Manufacturer | 5 | March 27, 2023 | 0 | 2 | 0 | api.fda.gov |
| AngioDynamics, Inc. | Marlborough, MA, United States | Specification developer | 5 | March 27, 2023 | 0 | 0 | 0 | api.fda.gov |
| Covidien | Lafayette, CO, United States | Specification developer | 5 | August 26, 2020 | 0 | 0 | 0 | api.fda.gov |
| Neuwave Medical, Inc. | Madison, WI, United States | Manufacturer, Specification developer | 4 | November 16, 2023 | 0 | 0 | 0 | api.fda.gov |
| Covidien | Plainfield, IN, United States | Contract manufacturer, Manufacturer | 2 | August 26, 2020 | 0 | 0 | 0 | api.fda.gov |
| Covidien | Boulder, CO, United States | Manufacturer | 2 | April 28, 2014 | 0 | 0 | 0 | api.fda.gov |
| MedWaves, Inc | San Diego, CA, United States | Manufacturer | 2 | November 25, 2020 | 0 | 0 | 0 | api.fda.gov |
| Varian Medical Systems, Inc | Austin, TX, United States | Complaint file establishment, Manufacturer, Specification developer | 2 | July 19, 2024 | 0 | 0 | 0 | api.fda.gov |
| Varian Medical Systems, Inc. | Shoreview, MN, United States | Specification developer | 2 | July 19, 2024 | 0 | 0 | 0 | api.fda.gov |
| miraDry, Inc. | San Jose, CA, United States | Complaint file establishment, Manufacturer | 1 | March 15, 2018 | 0 | 0 | 0 | api.fda.gov |
| CEA Medical Manufacturing, Inc. | Colorado Springs, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Command Medical Products, LLC. | Ormond Beach, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Covidien llc | Plymouth, MN, United States | Contract manufacturer, Manufacturer for export | 0 | 0 | 1 | 0 | api.fda.gov | |
| Linemaster Switch Corp. | Woodstock, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Modo Inc | Hillsboro, OR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Modo Inc. | Tualatin, OR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.