Data / Medical devices / Negative Pressure Wound Therapy Powered Suction Pump / United States
FDA-registered makers of Negative Pressure Wound Therapy Powered Suction Pump in the United States: 27 establishments
27 establishments in the United States are registered with the FDA to make Negative Pressure Wound Therapy Powered Suction Pump (product code OMP). 19 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
- Negative Pressure Wound Therapy Powered Suction Pump
- Product code
- OMP
- Country
- United States
Makers of Negative Pressure Wound Therapy Powered Suction Pump in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Kci Usa, Inc. | San Antonio, TX, United States | Complaint file establishment, Specification developer | 22 | May 23, 2024 | 0 | 1 | 0 | api.fda.gov |
| Kci Usa, Inc. | San Antonio, TX, United States | Manufacturer | 22 | May 23, 2024 | 0 | 6 | 0 | api.fda.gov |
| Genadyne Biotechnologies, Inc. | Hicksville, NY, United States | Manufacturer, Specification developer | 13 | March 12, 2026 | 0 | 0 | 0 | api.fda.gov |
| Genadyne Biotechnologies, Inc. | Bohemia, NY, United States | Manufacturer | 12 | March 12, 2026 | 0 | 0 | 0 | api.fda.gov |
| Genadyne Biotechnologies, Inc. | Mystic, CT, United States | Repackager or relabeler, Specification developer | 9 | December 23, 2024 | 0 | 0 | 0 | api.fda.gov |
| Alleva Medical Devices | Pomona, CA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 6 | March 8, 2023 | 0 | 0 | 0 | api.fda.gov |
| Cork Medical, LLC | Indianapolis, IN, United States | Manufacturer | 5 | June 27, 2025 | 0 | 0 | 0 | api.fda.gov |
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 5 | June 4, 2021 | 0 | 0 | 0 | api.fda.gov |
| Deroyal Industries, Inc. | Powell, TN, United States | Complaint file establishment, Specification developer | 5 | November 21, 2025 | 0 | 0 | 0 | api.fda.gov |
| Clear Choice Therapeutics, Inc. | Raleigh, NC, United States | Specification developer | 3 | February 5, 2024 | 0 | 0 | 0 | api.fda.gov |
| KCI NORTH IX (Technical Services Center) | San Antonio, TX, United States | Manufacturer | 3 | July 8, 2020 | 0 | 0 | 0 | api.fda.gov |
| New Horizon Medical Solutions | Las Vegas, NV, United States | Specification developer | 3 | September 21, 2022 | 0 | 0 | 0 | api.fda.gov |
| Pensar Medical | Houston, TX, United States | Specification developer | 3 | October 23, 2020 | 0 | 1 | 0 | api.fda.gov |
| DeRoyal Industries, Inc. | New Tazewell, TN, United States | Contract manufacturer, Repackager or relabeler | 2 | April 28, 2017 | 0 | 0 | 0 | api.fda.gov |
| ARGENTUM MEDICAL, LLC dba Bravida Medical | Geneva, IL, United States | Contract manufacturer, Manufacturer | 1 | September 12, 2014 | 0 | 0 | 0 | api.fda.gov |
| Bechtel Medical Inc | Phoenixville, PA, United States | Complaint file establishment, Manufacturer | 1 | May 4, 2026 | 0 | 0 | 0 | api.fda.gov |
| Deroyal Industries, Inc. | New Tazewell, TN, United States | Contract manufacturer, Repackager or relabeler | 1 | April 28, 2017 | 0 | 0 | 0 | api.fda.gov |
| Med Way Inc. | Buford, GA, United States | Manufacturer | 1 | August 19, 2024 | 0 | 0 | 0 | api.fda.gov |
| Medela LLC | Mchenry, IL, United States | Contract manufacturer, Repackager or relabeler | 1 | June 8, 2006 | 0 | 2 | 0 | api.fda.gov |
| Averto Medical | Redwood City, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioseal | Placentia, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cadent Technologies, Inc. | Temecula, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Design Standards Corp. | Charlestown, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Harmac Medical Products, Inc. | Buffalo, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Haywood Vocational Opportunities Inc. | Waynesville, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Keystone Manufacturing | Kalamazoo, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smith & Nephew Inc. | Oklahoma City, OK, United States | Contract manufacturer | 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.