Data / Medical devices / Intra-Abdominal Pressure Monitoring Device / United States
FDA-registered makers of Intra-Abdominal Pressure Monitoring Device in the United States: 5 establishments
5 establishments in the United States are registered with the FDA to make Intra-Abdominal Pressure Monitoring Device (product code PHU). 2 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
- Intra-Abdominal Pressure Monitoring Device
- Product code
- PHU
- Country
- United States
Makers of Intra-Abdominal Pressure Monitoring Device in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| C.R. Bard, Inc. | Covington, GA, United States | Contract sterilizer, Specification developer | 1 | August 1, 2007 | 0 | 1 | 0 | api.fda.gov |
| Sentinel Medical Technologies, LLC | Jacksonville, FL, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | October 29, 2021 | 0 | 0 | 0 | api.fda.gov |
| Cathtek LLC | Walkertown, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Potrero Medical, Inc. | Hayward, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tecan Cdmo Solutions MH, Corp. | Morgan Hill, CA, 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.