Data / Medical devices / United States / Uromedica, Inc.
Uromedica, Inc.: FDA-registered device maker in Plymouth, MN, United States, 1 PMA approval
Uromedica, Inc. is registered with the FDA (registration 3003477176) in Plymouth, MN, United States. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated November 24, 2015. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003477176
- Address
- 1840 Berkshire Ln N, Plymouth, MN, United States, 55441
- Owner or operator
- UROMEDICA, INC. (9047760)
- Roles
- Manufacturer
- First device listed
- August 24, 2017
- Registered through
- 2026
- Brand names listed
- ProACT Adjustable Continence Therapy for Men, ProACT Blunt Trocar, ProACT Implantation Instrument Set, ProACT Tissue Expanding Device II
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Incontinence, Mechanical/Hydraulic | EZY | 3 | Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| November 24, 2015 | P130018 | PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN | EZY | 6 | February 11, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 22, 2021 | 89184 | Class II | Terminated | UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile. | The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the sheath during a ProACT implantation procedure. | accessdata.fda.gov |
| April 10, 2019 | 85486 | Class II | Terminated | ProACT Implantation Instrument Set, is a reusable, steam sterilizable surgical instrument set consisting of a U-Channel Sheath through which the Pro ACT balloon implant is introduced. | Potential issue with the manufacture and inspection of U-channel sheaths in Implantation Instruments Sets. Affected U-channel sheaths may be more likely to cause damage to ProACT implant devices when passes through the sheaths. | accessdata.fda.gov |
Compare with other makers
Updated February 11, 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.