Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Omnisonics Medical Technologies with 8 510(k) clearances. The most recent is a 510(k) clearance dated Dec 15, 2008: MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM.
| Dec 15, 2008 | MODIFIED OMNIWAVE ENDOVASCULAR SYSTEMK083335 · QEY | 510(k) clearances |
| Sep 27, 2007 | OMNIWAVE ENDOVASCULAR SYSTEMK071762 · QEY | 510(k) clearances |
| Dec 8, 2005 | RESOLUTION ENDOVASCULAR SYSTEMK052428 · QEY | 510(k) clearances |
| Sep 1, 2004 | RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2K041705 · QEY | 510(k) clearances |
| Mar 8, 2001 | OMNISONICS ULTRASONIC SURGERY SYSTEM, MODEL STIK003824 · LFL | 510(k) clearances |
| Dec 15, 1999 | OMNISONICS ULTRASONIC PROBESK993628 · LFL | 510(k) clearances |
| Dec 6, 1999 | OMNISONIC ENDOSCOPIC DEFLECTORK993445 · GCM | 510(k) clearances |
| Jul 12, 1999 | OMNISONICS FLEXIBLE FIBER OPTIC ENDOSCOPE AND COUPLERK991377 · GCJ | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
