Data / Medical devices / Pump, Breast, Powered / United States
FDA-registered makers of Pump, Breast, Powered in the United States: 13 establishments
13 establishments in the United States are registered with the FDA to make Pump, Breast, Powered (product code HGX). 13 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
- Pump, Breast, Powered
- Product code
- HGX
- Country
- United States
Makers of Pump, Breast, Powered in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Medela LLC | Mchenry, IL, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 11 | April 10, 2026 | 0 | 3 | 0 | api.fda.gov |
| Hygeia Ii Medical Group, Inc. | Carlsbad, CA, United States | Complaint file establishment, Specification developer | 7 | September 11, 2024 | 0 | 0 | 0 | api.fda.gov |
| Willow Innovations Inc. | Mountain View, CA, United States | Manufacturer, Specification developer | 7 | September 27, 2024 | 0 | 0 | 0 | api.fda.gov |
| Ameda, Inc. | Austin, TX, United States | Complaint file establishment, Specification developer | 5 | March 20, 2025 | 0 | 1 | 0 | api.fda.gov |
| Evenflo Feeding Incorporated | West Chester, OH, United States | Specification developer | 3 | November 3, 2023 | 0 | 0 | 0 | api.fda.gov |
| Genadyne Biotechnologies, Inc. | Hicksville, NY, United States | Manufacturer | 2 | May 10, 2012 | 0 | 0 | 0 | api.fda.gov |
| Limerick Incorporate | Burbank, CA, United States | Complaint file establishment, Specification developer | 2 | February 20, 2015 | 0 | 0 | 0 | api.fda.gov |
| Babyation Inc. | Saint Louis, MO, United States | Manufacturer | 1 | April 4, 2018 | 0 | 0 | 0 | api.fda.gov |
| Bear Down Brands, LLC | Fullerton, CA, United States | Complaint file establishment, Specification developer | 1 | December 21, 2015 | 0 | 0 | 0 | api.fda.gov |
| Interfocus Inc. | Mountain View, CA, United States | Specification developer | 1 | December 19, 2025 | 0 | 0 | 0 | api.fda.gov |
| Luv N' Care, Ltd. | Monroe, LA, United States | Repackager or relabeler, Specification developer | 1 | March 24, 2010 | 0 | 0 | 0 | api.fda.gov |
| Pumpables Inc. | Middletown, DE, United States | Specification developer | 1 | May 6, 2022 | 0 | 0 | 0 | api.fda.gov |
| Wrex Products Inc. | Chico, CA, United States | Contract manufacturer, Repackager or relabeler | 1 | August 13, 2010 | 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.