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 13, 2026, FDA's public records list Mc3 Incorporated with 6 510(k) clearances and 2 device recalls. The most recent is a device recall dated Oct 11, 2023: NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support p….
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 |
|---|---|---|
| Oct 11, 2023 | NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide Class II · May have increased water path restriction within the heat exchanger, leading to degraded heat exchange performance durin | Device recalls |
| Oct 11, 2023 | NautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxidClass II · May have increased water path restriction within the heat exchanger, leading to degraded heat exchange performance durin | Device recalls |
| Oct 4, 2023 | Nautilus VF ECMO OxygenatorK232767 · BYS | 510(k) clearances |
| May 3, 2021 | MC3 Crescent Jugular Dual Lumen CatheterK203409 · PZS | 510(k) clearances |
| Apr 9, 2020 | Nautilus Smart ECMO ModuleK191935 · BYS | 510(k) clearances |
| Oct 29, 2018 | MC3 Vascular Access Kit 21030K182914 · DRE | 510(k) clearances |
| Jul 16, 2018 | MC3 Jugular Dual Lumen CatheterK180151 · PZS | 510(k) clearances |
| Nov 16, 2017 | MC3 QuickFlow Dual Lumen CatheterK171610 · PZS | 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
