Diagnostics 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.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Mesa Labs and its 1 subsidiaries with 24 510(k) clearances and 3 device recalls. The most recent is a 510(k) clearance dated Sep 2, 2020: SmartHDM-510 System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Mesa Labs and its 1 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Sep 2, 2020 | SmartHDM-510 SystemK201765 · FIZ | 510(k) clearances |
| Aug 5, 2019 | TDS Standard SolutionK191496 · FKH | 510(k) clearances |
| Apr 4, 2016 | ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus stearothermophilus, Catalog Number: PS-6-50, contaiClass II · Product resistance has fallen outside of label claim within expiry. | Device recalls |
| Sep 21, 2015 | Phoenix XL Dialysate MeterK150657 · FIZ | 510(k) clearances |
| Dec 3, 2014 | STERRAD CYCLESURE 24 PLUS BIOLOGICAL INDICATORK140589 · FRC | 510(k) clearances |
| Apr 18, 2013 | COMINED STANDARD SOLUTIONK130100 · FKH | 510(k) clearances |
| Mar 26, 2013 | SMART-WELL INCUBATORK122362 · FRC | 510(k) clearances |
| Jan 30, 2012 | SMART READ EZTEST STEAMK112018 · FRC | 510(k) clearances |
| Oct 21, 2009 | RAVEN PROTEST - STEAM BIOLOGICAL INDICATORK082756 · FRC | 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
