Medical device makerLabelled 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 Biotex, Inc. with 10 510(k) clearances. The most recent is a 510(k) clearance dated May 21, 2024: troCarWash™ System.
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 |
|---|---|---|
| May 21, 2024 | troCarWash™ SystemK233442 · OCX | 510(k) clearances |
| Feb 17, 2023 | troCarWash™ SystemK222695 · OCX | 510(k) clearances |
| Jul 20, 2021 | The SlideK203712 · LQZ | 510(k) clearances |
| Dec 1, 2016 | Phasor DrillK161704 · HBE | 510(k) clearances |
| Oct 6, 2009 | PHOTEX30 DIODE LASER SERIES: 980, 810, 940K092197 · GEX | 510(k) clearances |
| Sep 10, 2008 | VISUALASE THERMAL THERAPY SYSTEMK081656 · LLZ | 510(k) clearances |
| Aug 31, 2007 | VISUALASE THERMAL THERAPY SYSTEMK071328 · GEX | 510(k) clearances |
| Dec 12, 2006 | VISUALASE ENVISION SOFTWARE SYSTEMK063505 · LLZ | 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
