Valeritas, Incorporated

Medical device manufacturer in Marlborough, MA.

2510(k) clearances
0PMA approvals
5recalls

Device types

510(k) clearances

510(k)DeviceDecision
K103825V-Go Insulin Delivery SystemLZG · Traditional 02/23/2011SE
K100504V-Go Disposable Insulin Delivery Device, Model# V-Go 20, V-Go 30, V-GO40LZG · Traditional 12/01/2010SE

Recalls

RecallProductInitiated
Z-0199-2020 Class IIDEMO No Needle Corrugated Carton 30 U/D, Part Number 2568-02There is a potential for "No Needle Demo Units" to contain a needle. 07/03/2019Terminated
Z-0198-2020 Class IIDEMO No Needle Corrugated Carton 20 U/D, Part Number 2568-03There is a potential for "No Needle Demo Units" to contain a needle. 07/03/2019Terminated
Z-0197-2020 Class IIDEMO No Needle Corrugated Carton 40 U/D, Part Number 2260-01There is a potential for "No Needle Demo Units" to contain a needle. 07/03/2019Terminated
Z-0196-2020 Class IIDEMO No Needle Corrugated Carton 30 U/D, Part Number 2260-02There is a potential for "No Needle Demo Units" to contain a needle. 07/03/2019Terminated
Z-0195-2020 Class IIDEMO No Needle Corrugated Carton 20 U/D, Part Number 2260-03There is a potential for "No Needle Demo Units" to contain a needle. 07/03/2019Terminated