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 Sigma with 6 510(k) clearances and 1 device recall. The most recent is a device recall dated Apr 23, 2012: SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. Product Usag….
| Date | Record | Source |
|---|---|---|
| Apr 23, 2012 | SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. Product Usage: A customized in-house library of all IV and epidClass III · Sigma is a safety alert for the Master Drug Library (MDL) Editor software associated with the SIGMA Spectrum Infusion Pu | Device recalls |
| Jan 10, 1997 | SMART ADJUSTER (SA201)K962239 · LXM | 510(k) clearances |
| Aug 31, 1993 | SIGMA 7000 AND SIGMA70002K926191 · FRN | 510(k) clearances |
| May 15, 1985 | MCDB-110 MED. M6520 W/L-GLUTAMINE-25M M HERPES &K851737 · KIT | 510(k) clearances |
| May 15, 1985 | MCDB-105 MED. M6395, W/L-GLUTAMINE, 25M M HERPES &K851738 · KIT | 510(k) clearances |
| Jan 26, 1983 | SIGMA 7000-6000 INFUSION PUMPSK830038 · FRN | 510(k) clearances |
| Jan 26, 1983 | SIGMA 7000K820038 · FRN | 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
