Data / Medical devices / Catheter, Balloon Type / United States
FDA-registered makers of Catheter, Balloon Type in the United States: 14 establishments
14 establishments in the United States are registered with the FDA to make Catheter, Balloon Type (product code GBA). 0 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
- Catheter, Balloon Type
- Product code
- GBA
- Country
- United States
Makers of Catheter, Balloon Type in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioseal | Placentia, CA, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Marlborough, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Spencer, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| JFD-PK Medical LLC | Center Valley, PA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medgyn Products, Inc. | Westmont, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nova Vascular LLC | New York, NY, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ondine Research Laboratories/Ondine Biomedical Inc. (us) | Bothell, WA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Prospect Life Sciences | Westminster, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spineology Inc. | Saint Paul, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| TeleMed Systems | Northborough, MA, 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 | |
| Zeek Medical Devices, LLC | Doral, FL, United States | Manufacturer for export | 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.