Data / Medical devices / Immunoglobulin G (Igg) Infusion System / United States
FDA-registered makers of Immunoglobulin G (Igg) Infusion System in the United States: 6 establishments
6 establishments in the United States are registered with the FDA to make Immunoglobulin G (Igg) Infusion System (product code PKP). 1 has a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Immunoglobulin G (Igg) Infusion System
- Product code
- PKP
- Country
- United States
Makers of Immunoglobulin G (Igg) Infusion System in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Emed Technologies Corporation | El Dorado Hills, CA, United States | Specification developer | 7 | December 22, 2025 | 0 | 0 | 0 | api.fda.gov |
| Dimcogray Corp. Dba DG Medical | Centerville, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Innovative Health Sciences | Chester, NY, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Koru Medical Systems, Inc. | Mahwah, NJ, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PRIDE Industries | Roseville, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Taurus Engineering And Manufacturing, Inc. | Saint Paul, MN, 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.