Data / Medical devices / Enema Kit / United States
FDA-registered makers of Enema Kit in the United States: 12 establishments
12 establishments in the United States are registered with the FDA to make Enema Kit (product code FCE). 0 have 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
- Enema Kit
- Product code
- FCE
- Country
- United States
Makers of Enema Kit in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Apothecary Products, LLC. | Burnsville, MN, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CC Wellness LLC | Valencia, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dignity Lifts LLC | Clarkston, MI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Entana LLC | Savannah, GA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Healthmerica, Inc. | Fullerton, CA, United States | Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hollister Incorporated | Libertyville, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ICU Medical, Inc. | Dublin, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medegen Medical Products | Gallaway, TN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sealcath, LLC | Mount Pleasant, SC, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sterilab, Inc. | Naples, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Velentium Medical | Richmond, TX, 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.