Theramed, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Theramed, Inc. makes
Theramed, Inc. manufactures cerebrospinal fluid (CSF) management devices, including 2-way and 3-way FURUI shunts and hydrocephalus shunt systems designed for low, medium, and high-pressure applications. These products are intended for surgical placement to regulate CSF flow in patients with hydrocephalus.
The company’s portfolio is classified under FDA’s Class II medical devices and is listed via the 510(k) clearance pathway. The devices are regulated under US jurisdiction, with Theramed, Inc. headquartered in the United States.
Catalogue
Furui Shunt, 2-Way And 3-Way Ref K910004
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Theramed, Inc. have in the registry?
The registry currently lists 2 devices for Theramed, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Theramed, Inc.'s devices?
Among its 2 most recently registered devices, Theramed, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Theramed, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Theramed, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Theramed, Inc. in the registry?
The most recently registered devices listed for Theramed, Inc. include FURUI SHUNT, 2-WAY AND 3-WAY and HYDROCEPHALUS SHUNT SYSTEM, LOW/MEDIUM/HIGH PRESS..