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 13, 2026, FDA's public records list Baxano with 10 510(k) clearances. The most recent is a 510(k) clearance dated Jul 27, 2012: IO-TOME DEVICE.
| Date | Record | Source |
|---|---|---|
| Jul 27, 2012 | IO-TOME DEVICEK113073 · HAE | 510(k) clearances |
| Apr 11, 2012 | NEURO CHECK DEVICE WITH IO-FLEX WIREK113533 · HAE | 510(k) clearances |
| Jul 7, 2011 | NEURO CHECK DEVICE WITH IO-FLEX WIREK110696 · ETN | 510(k) clearances |
| Jan 19, 2011 | IO-FLEX CATHETERK102594 · BSO | 510(k) clearances |
| Jul 23, 2010 | MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIESK100958 · HAE | 510(k) clearances |
| Oct 2, 2009 | BAXANO NEURO CHECK DEVICEK092729 · ETN | 510(k) clearances |
| Sep 17, 2008 | BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25K081742 · ETN | 510(k) clearances |
| Mar 4, 2008 | BAXANO ULTRA LOW PROFILE RONGEURK080494 · HAE | 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