Mc3, Inc.
Mc3, Inc. holds FDA 510(k) medical device clearances, first cleared 2021, most recent 2023, with 2 FDA device recalls on record.
Top product codes for Mc3, Inc.
FDA recalls by Mc3, Inc.
- Z-1310-2024 — NautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Product Number: 48135, 48135E
- Z-1309-2024 — NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Product Number: (1) 48145; (2) 48145E
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Mc3, Inc.
Data sourced from openFDA. This site is unofficial and independent of the FDA.