Data / Medical devices / Wound Dressing Kit / United States
FDA-registered makers of Wound Dressing Kit in the United States: 12 establishments
12 establishments in the United States are registered with the FDA to make Wound Dressing Kit (product code MCY). 2 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.
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- Device
- Wound Dressing Kit
- Product code
- MCY
- Country
- United States
Makers of Wound Dressing Kit in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Busse Hospital Disposables | Hauppauge, NY, United States | Manufacturer, Manufacturer for export, Repackager or relabeler | 1 | July 14, 1995 | 0 | 2 | 1 | api.fda.gov |
| Customed, Inc. | Fajardo, PR, United States | Manufacturer | 1 | June 7, 1993 | 0 | 4 | 1 | api.fda.gov |
| Border Opportunity Saver Systems, Inc. | Del Rio, TX, United States | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bound Tree Medical, LLC | Grand Prairie, TX, 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 | |
| Deroyal Industries, Inc. | Powell, TN, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Deroyal Industries, Inc. | New Tazewell, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hologic, Inc. | Marlborough, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Action Industries, Inc. 306 | Arden, NC, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Laredo | Laredo, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Polymer Science, Inc. | Monticello, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Instruments | Portage, MI, 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.