Data / Medical devices / System, Hemodynamic, Implantable / United States
FDA-registered makers of System, Hemodynamic, Implantable in the United States: 8 establishments
8 establishments in the United States are registered with the FDA to make System, Hemodynamic, Implantable (product code MOM). 5 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
- System, Hemodynamic, Implantable
- Product code
- MOM
- Country
- United States
Makers of System, Hemodynamic, Implantable in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Abbott Medical | Atlanta, GA, United States | Manufacturer | 0 | 1 | 7 | 0 | api.fda.gov | |
| Abbott Medical | Atlanta, GA, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| ENDOTRONIX (Naperville) | Naperville, IL, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Thoratec Corp. | Pleasanton, CA, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Thoratec Corporation | San Ramon, CA, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Isomedix Operations Inc. | Spartanburg, SC, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Saline Lectronics | Saline, MI, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Uim Pressure Implant Inc | Ypsilanti, MI, United States | Manufacturer for export | 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.