Uromedica, Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Uromedica, Inc.”, plus 1 PMA decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EZY | Device, Incontinence, Mechanical/Hydraulic | 1 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P130018 | PMA | PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN | 2015-11-24 |
Recalls
2 product recalls in 2 recall events; 1 initiated in the last five years. Most recent: 2021-11-22.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Uromedica, Inc. is the lead sponsor of 4 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT04248283: Adjustable Continence Therapy (ACT) for the Treatment of Female SUI (Recruiting, started 2021-01-26)
- NCT03767595: ProACT Post-Approval Study (Recruiting, started 2019-02-19)
- NCT00277095: ProACT Therapy for the Treatment of Stress Urinary Incontinence in Males (Completed, started 2005-08)
- NCT00113555: Adjustable Continence Therapy (ACT) Device for the Treatment of Female Stress Urinary Incontinence (Completed, started 2001-12)
Frequently asked questions
How many FDA 510(k) clearances are listed under Uromedica, Inc.?
FDA lists 0 510(k) clearances under the applicant name “Uromedica, Inc.”, plus 1 PMA decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Uromedica, Inc.?
The most frequent FDA product codes under this applicant name are EZY (Device, Incontinence, Mechanical/Hydraulic, 1).
Next steps
- See all 0 Uromedica, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EZY, Uromedica, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.