Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Bionix Development Corporation with 13 510(k) clearances. The most recent is a 510(k) clearance dated Oct 24, 2018: GastroFlush.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Oct 24, 2018 | GastroFlushK180605 · KNT | 510(k) clearances |
| Mar 8, 2016 | TruGuard Custom Tongue and Jaw PositionerK153270 · IYE | 510(k) clearances |
| Mar 7, 2013 | LITTLE ANGELS SWADDLING BLANKETK123411 · PDH | 510(k) clearances |
| May 3, 2012 | EMBRACE THERMOPLASTICK120335 · IYE | 510(k) clearances |
| May 11, 2010 | OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500K100691 · IYE | 510(k) clearances |
| Apr 9, 2010 | T-FORM EXTREMITY IMMOBILIZER, MODEL RT-6060K100264 · IYE | 510(k) clearances |
| Apr 1, 2005 | THIGH AND FOOT POSITIONER, SUPRONE PLUS, MODEL RT-6010K050701 · IYE | 510(k) clearances |
| Apr 9, 2004 | PELVIS BELLYBOARD PLUS PATIENT POSITIONING SYSTEMK040773 · IYE | 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
