Data / Medical devices / Needle, Biopsy, Cardiovascular / United States
FDA-registered makers of Needle, Biopsy, Cardiovascular in the United States: 11 establishments
11 establishments in the United States are registered with the FDA to make Needle, Biopsy, Cardiovascular (product code DWO). 2 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Needle, Biopsy, Cardiovascular
- Product code
- DWO
- Country
- United States
Makers of Needle, Biopsy, Cardiovascular 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 | Contract manufacturer, Manufacturer | 1 | June 19, 1992 | 0 | 0 | 0 | api.fda.gov |
| Argon Medical Devices, Inc. | Wheeling, IL, United States | Contract manufacturer, Manufacturer | 1 | April 11, 1989 | 0 | 1 | 0 | api.fda.gov |
| Bioseal | Placentia, CA, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hart Enterprises, Inc. | Sparta, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Merit Medical Systems, Inc. | South Jordan, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mermaid Medical A/S (FL Site) | University Park, FL, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phoenix Instruments, Inc. | Lisle, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sabin Corporation | Blmgtn, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 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 |
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.