Ivenix, Inc.

Medical device manufacturer in North Andover, MA.

2510(k) clearances
0PMA approvals
1recalls

Device types

510(k) clearances

510(k)DeviceDecision
K213089Ivenix Infusion System, LVP Epidural Administraion Set NRFit ConnectorFPA · Special 11/10/2021SE
K183311Ivenix Infusion System (IIS)FRN · Traditional 06/07/2019SE

Recalls

RecallProductInitiated
Z-1381-2022 Class IIIvenix Infusion System (IIS)Downstream occlusion alarm is sometimes immediately followed by a pump problem alarm. 04/22/2022Terminated