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., part of Natus MedicalLabelled by claude-sonnet-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 14, 2026, FDA's public records list Nicolet Biomedical with 18 510(k) clearances. The most recent is a 510(k) clearance dated Apr 21, 2003: NICOLET PIONEER TC8080.
| Apr 21, 2003 | NICOLET PIONEER TC8080K020754 · IYN | 510(k) clearances |
| Aug 23, 2002 | BRAINETK021986 · GXY | 510(k) clearances |
| Jun 24, 2002 | SUBDURAL STRIP ELECTRODEK021144 · GYC | 510(k) clearances |
| Apr 22, 2002 | SNAP EEG MONITORK020218 · OLW | 510(k) clearances |
| Apr 18, 2002 | VERSALAB APMK013281 · HGM | 510(k) clearances |
| Apr 17, 2002 | NICOLET ELECTROCAUTERY DETECTORK020955 · ETN | 510(k) clearances |
| Dec 20, 2001 | NICOLET ELECTROMAGNETIC NAVIGATION SYSTEMK013419 · LLZ | 510(k) clearances |
| Sep 6, 2001 | STERILE EMG ELECTRODESK011818 · IKT | 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
