Bigfoot Biomedical, Inc.

Medical device manufacturer in Milpitas, CA.

2510(k) clearances
0PMA approvals
1recalls

Device types

510(k) clearances

510(k)DeviceDecision
K222280Bigfoot Unity® Diabetes Management SystemQLG · Traditional 03/01/2023SE
K202145Bigfoot Unity Diabetes Management SystemQLG · Traditional 05/07/2021SE

Recalls

RecallProductInitiated
Z-1997-2025 Class IIBigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP…Due to a software/firmware issue diabetes management system may provide a device error and cause the insulin… 05/21/2025Open, Classified