Data / Medical devices / Balloon, Epistaxis / United States
FDA-registered makers of Balloon, Epistaxis in the United States: 17 establishments
17 establishments in the United States are registered with the FDA to make Balloon, Epistaxis (product code EMX). 5 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Balloon, Epistaxis
- Product code
- EMX
- Country
- United States
Makers of Balloon, Epistaxis in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Beaver-Visitec International, Inc. | Waltham, MA, United States | Specification developer | 2 | February 12, 1993 | 0 | 0 | 0 | api.fda.gov |
| Boston Medical Products, Inc. | Shrewsbury, MA, United States | Contract manufacturer, Manufacturer | 1 | June 26, 1997 | 0 | 0 | 0 | api.fda.gov |
| Gyrus Acmi, Inc. | Bartlett, TN, United States | Manufacturer, Repackager or relabeler | 1 | September 14, 1999 | 0 | 0 | 0 | api.fda.gov |
| Gyrus ACMI, Inc. | Brooklyn Park, MN, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | September 14, 1999 | 0 | 0 | 0 | api.fda.gov |
| Hemostasis, LLC | Saint Paul, MN, United States | Manufacturer | 1 | November 14, 2022 | 0 | 0 | 0 | api.fda.gov |
| ArthroCare Corporation | Austin, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carwild Corp. | New London, CT, United States | Contract manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coagco LLC | Cleveland, OH, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DeRoyal Industries, Inc. | New Tazewell, TN, United States | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hydrofera, LLC. | Manchester, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Invotec International, Inc. | Jacksonville, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integra LifeSciences Production Corporation | Mansfield, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Xomed, Inc. | Jacksonville, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Summit Medical LLC | Saint Paul, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Instruments | Portage, MI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wright Medical Technology, Inc. | Arlington, TN, 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.