Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Infinite Biomedical Technologies, LLC with 6 510(k) clearances and 1 AI-enabled device. The most recent is a 510(k) clearance dated Apr 15, 2024: Glide (91000-GL-X).
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.
| Apr 15, 2024 | Glide (91000-GL-X)K240884 · GXY | 510(k) clearances |
| Oct 5, 2018 | Sense System with IBT ElectrodesK182112 · GXY | 510(k) clearances |
| Oct 5, 2018 | Sense System with IBT ElectrodesK182112 · Neurology | AI-enabled devices |
| Mar 21, 2018 | Element System with IBT ElectrodesK173571 · GXY | 510(k) clearances |
| Jul 30, 2010 | VIGILANT EEG MONITOR MODEL VIGILANT 2.0K101386 · GWQ | 510(k) clearances |
| Nov 6, 2009 | VIGILANT EEG MONITOR, VIGILANT 2.0K091963 · OLT | 510(k) clearances |
| Feb 15, 2008 | MODEL I-2000 MONITORK072382 · OLT | 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
