Prodeon Medical, Inc.
United StatesFDA applicant, unverified FDA FEI 3045323889
- Devices
- 4
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Prodeon Medical, Inc. makes
Prodeon Medical, Inc. manufactures the Urocross Expander System (Model Numbers ES2018 and ES3025) and the Prodeon Urethral Sheath System, which are medical devices used in urological procedures.
These devices are classified as Class II and are listed in the FDA 510(k) registry. Prodeon Medical, Inc. is based in the US.
Catalogue
- Registry: GUDID
Urocross Expander System (UES-2018-C1) Ref K261342
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Prodeon Urethral Sheath System Ref K252572
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3045323889
- DUNS number
- 111233815
- Address
- 2200 Zanker Rd Ste F, San Jose, CA, 95131
Frequently asked questions
How many devices does Prodeon Medical, Inc. have in the registry?
The registry currently lists 4 devices for Prodeon Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Prodeon Medical, Inc.'s devices?
Among its 4 most recently registered devices, Prodeon Medical, Inc. has devices listed in FDA 510(k) (3 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Prodeon Medical, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Prodeon Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Prodeon Medical, Inc. in the registry?
The most recently registered devices listed for Prodeon Medical, Inc. include Prodeon Urethral Sheath System PUS1832, Urocross Expander System (UES-2018-C1), Urocross Expander System (Model Numbers ES2018 and ES3025) and Prodeon Urethral Sheath System.