Data / Medical devices / Cardiovascular Procedure Kit / United States
FDA-registered makers of Cardiovascular Procedure Kit in the United States: 19 establishments
19 establishments in the United States are registered with the FDA to make Cardiovascular Procedure Kit (product code OEZ). 0 have a 510(k) clearance or PMA approval on file and 6 have a recall event. FDA data exported November 2, 2026.
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- Device
- Cardiovascular Procedure Kit
- Product code
- OEZ
- Country
- United States
Makers of Cardiovascular Procedure Kit in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Argon Medical Devices Inc. | Athens, TX, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 1 | 1 | api.fda.gov | |
| Avid Medical, Inc. A Medical Action Ind. Company 305 | Toano, VA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 8 | 3 | api.fda.gov | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | Chelmsford, MA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Johns Creek, GA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health 200, LLC | El Paso, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cordis US Corp. | Miami Lakes, FL, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ENDOTRONIX (Naperville) | Naperville, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GRI-Alleset, Inc. | Flowery Branch, GA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Invenio Alternate Care Solutions, LLC | Peachtree Corners, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ivy Biomedical Systems, Inc. | Branford, CT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Action Industries, Inc. 306 | Arden, NC, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 1 | 1 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Laredo | Laredo, TX, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medline Industries, LP - SPT | Waukegan, IL, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 1 | 0 | api.fda.gov | |
| Merit Medical Systems, Inc | Chester, VA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Merit Medical Systems, Inc. | South Jordan, UT, United States | Contract manufacturer, Manufacturer | 0 | 0 | 4 | 0 | api.fda.gov | |
| MG Medical Products LLC | Cincinnati, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medline Industries (NAMIC Division) - Glen Falls | Glens Falls, NY, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shockwave Medical, Inc. | Santa Clara, CA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Terumo Cardiovascular Systems Corporation | Elkton, MD, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 1 | 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.