Uromedica Inc
Country not established
- Devices
- 9
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Uromedica Inc makes
Uromedica Inc manufactures devices for the treatment of male urinary incontinence, including implantable systems and associated instrumentation. Their portfolio includes adjustable continence therapy implants, trocars, and tissue expansion tools designed for surgical placement and adjustment. These products are intended for patients requiring long-term management of urinary control issues.
The company’s devices are classified as Class III under US regulations, requiring premarket approval (PMA) or unique device identifiers (UDI) for compliance. Their products are listed in the FDA’s regulatory databases, reflecting their authorised status for distribution in the United States. The manufacturer is based in the US.
Catalogue
- GUDID
- GUDID
- GUDID
- GUDID
- GUDID
- GUDID
- GUDID
- GUDID
ProACT Adjustable Continence Therapy for Men Ref P130018
PMA PMA
Company details
- DUNS number
- 080378479
FDA recalls
FDA recall records list 2 recalls initiated by UROMEDICA INC, the earliest on 2019-04-10 and the most recent on 2021-11-22. By recorded status: 2 terminated. The reasons filed fall into these groups: manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 1
- 2020 0
- 2021 1
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2021
- 22 Nov 2021 Z-0458-2022 Class II Terminated The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the sheath during a ProACT implantation procedure.
2019
- 10 Apr 2019 Z-1808-2020 Class II Terminated 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.
Frequently asked questions
How many devices does UROMEDICA INC have in the registry?
The registry currently lists 9 devices for UROMEDICA INC. Devices recorded under merged duplicate company entries are counted once.
Which registries list UROMEDICA INC's devices?
Among its 9 most recently registered devices, UROMEDICA INC has devices listed in FDA PMA (1 device) and FDA GUDID (8 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do UROMEDICA INC's devices fall under?
Among its 9 most recently registered devices, the classes recorded for UROMEDICA INC's devices are Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for UROMEDICA INC?
FDA recall records list 2 recalls initiated by UROMEDICA INC, the most recent initiated on 2021-11-22. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from UROMEDICA INC in the registry?
The most recently registered devices listed for UROMEDICA INC include ProACT - Replacement Actuator - Tissue Expanding Device II 750043, ProACT - Implantation Instrument Set 750041, ProACT Adjustable Continence Therapy for Men – 12 cm Single Implant - Revision 800022-12 and ProACT Adjustable Continence Therapy for Men – 12 cm Implants - Patient Pack 800018-12.