Data / Medical devices / Syringe, Balloon Inflation / United States
FDA-registered makers of Syringe, Balloon Inflation in the United States: 14 establishments
14 establishments in the United States are registered with the FDA to make Syringe, Balloon Inflation (product code MAV). 12 have a 510(k) clearance or PMA approval on file and 4 have a recall event. FDA data exported November 2, 2026.
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- Device
- Syringe, Balloon Inflation
- Product code
- MAV
- Country
- United States
Makers of Syringe, Balloon Inflation in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Atrion Medical Products, Inc. | Arab, AL, United States | Manufacturer | 2 | July 12, 2006 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 2 | April 17, 2014 | 0 | 0 | 0 | api.fda.gov |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer, Specification developer | 2 | April 17, 1996 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Vascular | Danvers, MA, United States | Specification developer | 2 | April 13, 2022 | 0 | 2 | 0 | api.fda.gov |
| Abbott Vascular | Temecula, CA, United States | Complaint file establishment, Specification developer | 1 | May 8, 1996 | 0 | 3 | 0 | api.fda.gov |
| Abbott Vascular | Santa Clara, CA, United States | Specification developer | 1 | May 8, 1996 | 0 | 0 | 0 | api.fda.gov |
| Allwell Medical Corporation | Raleigh, NC, United States | Repackager or relabeler, Specification developer | 1 | December 19, 2012 | 0 | 0 | 0 | api.fda.gov |
| Argon Medical Devices Inc. | Athens, TX, United States | Manufacturer, Repackager or relabeler | 1 | April 17, 1996 | 0 | 0 | 0 | api.fda.gov |
| Bard Peripheral Vascular, Inc. | Tempe, AZ, United States | Specification developer | 1 | January 12, 2015 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Marlborough, MA, United States | Complaint file establishment, Specification developer | 1 | December 8, 1992 | 0 | 1 | 0 | api.fda.gov |
| Cook Incorporated | Spencer, IN, United States | Manufacturer | 1 | December 3, 1990 | 0 | 0 | 0 | api.fda.gov |
| ICU Medical, Inc. | Dublin, OH, United States | Manufacturer | 1 | August 11, 1994 | 0 | 0 | 0 | api.fda.gov |
| Merit Medical Systems, Inc. | South Jordan, UT, United States | Manufacturer | 0 | 0 | 3 | 0 | api.fda.gov | |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 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.