Data / Medical devices / Ear, Nose, And Throat Stereotaxic Instrument / United States
FDA-registered makers of Ear, Nose, And Throat Stereotaxic Instrument in the United States: 12 establishments
12 establishments in the United States are registered with the FDA to make Ear, Nose, And Throat Stereotaxic Instrument (product code PGW). 5 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.
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- Device
- Ear, Nose, And Throat Stereotaxic Instrument
- Product code
- PGW
- Country
- United States
Makers of Ear, Nose, And Throat Stereotaxic Instrument in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Acclarent, Inc. | Irvine, CA, United States | Specification developer | 8 | July 21, 2023 | 0 | 3 | 0 | api.fda.gov |
| Medtronic Navigation, Inc. | Lafayette, CO, United States | Manufacturer, Specification developer | 6 | March 16, 2026 | 0 | 1 | 0 | api.fda.gov |
| Hill-Rom, Inc. | Batesville, IN, United States | Manufacturer | 2 | June 26, 2020 | 0 | 0 | 0 | api.fda.gov |
| Stryker Instruments | Portage, MI, United States | Complaint file establishment, Specification developer | 2 | February 21, 2020 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Xomed, Inc. | Jacksonville, FL, United States | Manufacturer | 1 | September 4, 2026 | 0 | 0 | 0 | api.fda.gov |
| Comdel Innovation, LLC | Wahpeton, ND, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Midwest Products And Engineering | Milwaukee, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MSK Precision Products, Inc. | Tamarac, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Multisource Manufacturing LLC | Longmont, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NextPhase Medical Devices LLC | Rochester, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Corp. | Kalamazoo, MI, United States | Contract manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Viant AS&O Holdings, LLC | Laconia, NH, 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.