Uromedica Inc.
Plymouth, MN, US
UROMEDICA, INC. appears in FDA device records in Plymouth, MN. FDA records list no 510(k) clearances, 7 PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003477176 | 3003477176 | UROMEDICA, INC. | 1840 Berkshire Ln N, PLYMOUTH, MN 55441 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0458-2022 | 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. | Class II | Terminated | |
| Z-1808-2020 | 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. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain