Uromedica Inc.
Medical device manufacturer in Plymouth, MN.
0510(k) clearances
1PMA approvals
2recalls
PMA approvals
- P130018 Proact Adjustable Continence Therapy for Men · 11/24/2015 · 6 supplements
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0458-2022 Class II | 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… | 11/22/2021Terminated |
| Z-1808-2020 Class II | ProACT Implantation Instrument Set, is a reusable, steam sterilizable surgical…Potential issue with the manufacture and inspection of U-channel sheaths in Implantation Instruments Sets.… | 04/10/2019Terminated |