Twin Star Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Twin Star Medical, Inc. makes
Twin Star Medical, Inc. manufactures compartment syndrome monitoring systems, including standalone pressure monitors and integrated catheter systems for fluid collection. These devices are designed to detect and manage elevated pressure in soft tissues, aiding in the prevention of compartment syndrome. The portfolio includes models for general use and extremity-specific applications, combining pressure monitoring with fluid drainage capabilities.
The company’s devices are classified as Class II (U) under FDA regulations and are listed via the 510(k) pathway. These products are intended for use in the United States, where they are subject to FDA oversight. No additional international registries are specified.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Twin Star Medical, Inc. have in the registry?
The registry currently lists 4 devices for Twin Star Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Twin Star Medical, Inc.'s devices?
Among its 4 most recently registered devices, Twin Star Medical, Inc. has devices listed in FDA 510(k) (4 devices).
What are the newest devices from Twin Star Medical, Inc. in the registry?
The most recently registered devices listed for Twin Star Medical, Inc. include TWIN STAR COMPARTMENT PRESSURE MONITORING AND FLUID COLLECTION MONITOR (CMS MONITOR), TWIN STAR COMPARTMENT PRESSURE MONITOR AND FLUID COLLECTION CATHETER SYSTEM (CMS-II), TWIN STAR COMPARTMENT SYNDROME PRESSURE MONITORING AND FLUID COLLECTION CATHETER SYSTEM and TWIN STAR EXTREMITY COMPARTMENT SYNDROME MONITOR AND FLUID COLLECTION CATHETER SYSTEM.