Data / Medical devices / Pump, Breast, Non-Powered / United States
FDA-registered makers of Pump, Breast, Non-Powered in the United States: 11 establishments
11 establishments in the United States are registered with the FDA to make Pump, Breast, Non-Powered (product code HGY). 3 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Pump, Breast, Non-Powered
- Product code
- HGY
- Country
- United States
Makers of Pump, Breast, Non-Powered in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Ameda, Inc. | Austin, TX, United States | Complaint file establishment, Specification developer | 2 | August 15, 2001 | 0 | 1 | 0 | api.fda.gov |
| Medela LLC | Mchenry, IL, United States | Manufacturer | 2 | February 25, 1985 | 0 | 0 | 0 | api.fda.gov |
| Mai/Genesis | Elmwood, WI, United States | Manufacturer | 1 | February 10, 1997 | 0 | 0 | 0 | api.fda.gov |
| Entana LLC | Savannah, GA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Evenflo Feeding Incorporated | West Chester, OH, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FridaBaby LLC | Miami, FL, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hygeia Ii Medical Group, Inc. | Carlsbad, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Luv N' Care, Ltd. | Monroe, LA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Munchkin Inc. | Van Nuys, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Neotech Products, LLC | Valencia, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Willow Innovations Inc. | Mountain View, CA, United States | Manufacturer, Repackager or relabeler, 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.