Data / Medical devices / Device, Cystometric, Hydraulic / United States
FDA-registered makers of Device, Cystometric, Hydraulic in the United States: 14 establishments
14 establishments in the United States are registered with the FDA to make Device, Cystometric, Hydraulic (product code FEN). 8 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
- Device, Cystometric, Hydraulic
- Product code
- FEN
- Country
- United States
Makers of Device, Cystometric, Hydraulic in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Laborie Medical Technologies Corp. | Portsmouth, NH, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 2 | March 30, 1995 | 0 | 1 | 0 | api.fda.gov |
| C.R. Bard, Inc. | Covington, GA, United States | Contract sterilizer, Specification developer | 1 | September 21, 1993 | 0 | 0 | 0 | api.fda.gov |
| Coopersurgical, Inc. | Trumbull, CT, United States | Manufacturer | 1 | January 18, 1996 | 0 | 0 | 0 | api.fda.gov |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 1 | October 8, 1993 | 0 | 0 | 0 | api.fda.gov |
| Cook Incorporated | Spencer, IN, United States | Manufacturer | 1 | October 8, 1993 | 0 | 0 | 0 | api.fda.gov |
| SRS Medical | Chelmsford, MA, United States | Manufacturer | 1 | December 21, 2021 | 0 | 0 | 0 | api.fda.gov |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 1 | June 15, 1995 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 1 | June 15, 1995 | 0 | 0 | 0 | api.fda.gov |
| C.R. Bard, Inc. | Queensbury, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Clinical Innovations, LLC | Murray, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cogentix Medical, Inc. | Westborough, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gemini Medical Technologies, LLC | Largo, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ICU Medical, Inc. | Dublin, OH, United States | Contract manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| The Prometheus Group | Dover, NH, United States | 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.