Data / Medical devices / System/Device, Pharmacy Compounding / United States
FDA-registered makers of System/Device, Pharmacy Compounding in the United States: 15 establishments
15 establishments in the United States are registered with the FDA to make System/Device, Pharmacy Compounding (product code NEP). 0 have a 510(k) clearance or PMA approval on file and 5 have a recall event. FDA data exported November 2, 2026.
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- Device
- System/Device, Pharmacy Compounding
- Product code
- NEP
- Country
- United States
Makers of System/Device, Pharmacy Compounding in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| ARxIUM, INC. | Buffalo Grove, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aseptikits, LLC | North Salt Lake, UT, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B. Braun Medical Inc. | Bethlehem, PA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B. Braun Us Device Manufacturing LLC | Allentown, PA, United States | Contract manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Baxter Healthcare Corporation | Round Lake, IL, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 1 | 1 | api.fda.gov | |
| Biovire, Inc. | Brighton, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cadence Device, Inc. | Cranberry Township, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Icu Medical, Inc | Salt Lake City, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Icu Medical, Inc. | San Clemente, CA, United States | Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| ICU Medical, Inc. | Dublin, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MPS Pharma & Medical, Inc. | Brea, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Omnicell, Inc. | Cranberry Township, PA, United States | Complaint file establishment, Specification developer | 0 | 0 | 1 | 1 | api.fda.gov | |
| Omnicell, Inc. | Warrendale, PA, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| PDV MedTech | Morgan Hill, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plexus Corp. | Buffalo Grove, IL, 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.