Omnisonics Medical Technologies
Country not established
- Devices
- 8
What Omnisonics Medical Technologies makes
Omnisonics Medical Technologies manufactures endovascular and surgical devices, including ultrasonic systems for thrombus removal and vascular interventions, such as the OmniWave and Resolution thromectomy systems. Their portfolio also includes ultrasonic probes for precision surgery, a flexible fiber optic endoscope with coupler for endoscopic procedures, and an endoscopic deflector for targeted interventions. These devices are designed for use in vascular and minimally invasive surgical applications.
The company’s devices are classified under FDA Class II and Unclassified (U) categories, with regulatory submissions recorded in the FDA 510(k) database. Their products are listed under U.S. regulatory authorities, and the manufacturer is based in the United States.
Catalogue
Modified Omniwave Endovascular System Ref K083335
Regimes: 510(k) Registry: 510(k)Resolution Thrombectomy System, Model Ev-2 Ref K041705
Regimes: 510(k) Registry: 510(k)Omnisonics Ultrasonic Surgery System, Model Sti Ref K003824
Regimes: 510(k) Registry: 510(k)Omnisonic Endoscopic Deflector Ref K993445
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Omniwave Endovascular System Ref K071762
Regimes: 510(k) Registry: 510(k)Omnisonics Ultrasonic Probes Ref K993628
Regimes: 510(k) Registry: 510(k)Resolution Endovascular System Ref K052428
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Omnisonics Medical Technologies have in the registry?
The registry currently lists 8 devices for Omnisonics Medical Technologies. Devices recorded under merged duplicate company entries are counted once.
Which registries list Omnisonics Medical Technologies's devices?
Among its 8 most recently registered devices, Omnisonics Medical Technologies has devices listed in FDA 510(k) (8 devices).
What risk classes do Omnisonics Medical Technologies's devices fall under?
Among its 8 most recently registered devices, the classes recorded for Omnisonics Medical Technologies's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Omnisonics Medical Technologies in the registry?
The most recently registered devices listed for Omnisonics Medical Technologies include MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM, RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2, OMNISONICS ULTRASONIC SURGERY SYSTEM, MODEL STI and OMNISONIC ENDOSCOPIC DEFLECTOR.