Omnisonics Medical Technologies
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 8
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K083335 | MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM | December 15, 2008 |
| K071762 | OMNIWAVE ENDOVASCULAR SYSTEM | September 27, 2007 |
| K052428 | RESOLUTION ENDOVASCULAR SYSTEM | December 8, 2005 |
| K041705 | RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2 | September 1, 2004 |
| K003824 | OMNISONICS ULTRASONIC SURGERY SYSTEM, MODEL STI | March 8, 2001 |
| K993628 | OMNISONICS ULTRASONIC PROBES | December 15, 1999 |
| K993445 | OMNISONIC ENDOSCOPIC DEFLECTOR | December 6, 1999 |
| K991377 | OMNISONICS FLEXIBLE FIBER OPTIC ENDOSCOPE AND COUPLER | July 12, 1999 |