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BIGFOOT BIOMEDICAL, INC.

US

Last updated September 17, 2026

Information

Country
US
Address
1820 McCarthy Boulevard, Milpitas, CA, 95035
Website
—
LinkedIn
—
Facebook
—
Email
—
Phone
—
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
3016525500
DUNS Number
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Catalogue (63)

Page 1 of 2
DeviceModel / ReferenceRegistriesClassStatus
Bigfoot Unity Diabetes Management System FG-300198
FDA UDI
Class IIActive
Bigfoot Unity Diabetes Management System ASM-10048
FDA UDI
Class IIActive
Bigfoot Unity Diabetes Management System FG-300171
FDA UDI
Class IIActive
Bigfoot Unity Diabetes Management System FG-300191
FDA UDI
Class IIActive
Bigfoot Unity Diabetes Management System FG-300190
FDA UDI
Class IIActive
Bigfoot Unity Diabetes Management System FG-300178
FDA UDI
Class IIActive
Bigfoot Unity Diabetes Management System FG-300174
FDA UDI
Class IIActive
Bigfoot Unity Diabetes Management System FG-300203
FDA UDI
Class IIActive
Bigfoot Unity FG-300992
FDA UDI
Class IIActive
Bigfoot Unity Diabetes Management System ASM-10053
FDA UDI
Class IIActive
Bigfoot Unity Diabetes Management System FG-300186
FDA UDI
Class IIActive
Bigfoot Meter Blood Glucose Monitoring System FG-10027
FDA UDI
Class IIActive
Bigfoot Unity FG-300993
FDA UDI
Class IIActive
Bigfoot Unity FG-301191
FDA UDI
Class IIActive
Bigfoot Alcohol Prep Pads, 70% v/v Isopropyl Alcohol FG-300145
FDA UDI
Class IActive
Bigfoot Unity Diabetes Management System ASM-10051
FDA UDI
Class IIActive
Bigfoot Test Strips Blood Glucose Test Strips FG-300295
FDA UDI
Class IIActive
Bigfoot Unity Diabetes Management System FG-300172
FDA UDI
Class IIActive
Bigfoot Unity Diabetes Management System FG-300197
FDA UDI
Class IIActive
Bigfoot Lancets 33 Gauge FG-300294
FDA UDI
Class IIActive
Bigfoot Unity FG-300995
FDA UDI
Class IIActive
Bigfoot Unity Diabetes Management System ASM-10046
FDA UDI
Class IIActive
Bigfoot Unity FG-300994
FDA UDI
Class IIActive
Bigfoot Unity FG-300997
FDA UDI
Class IIActive
Bigfoot Unity Diabetes Management System FG-300205
FDA UDI
Class IIActive
Bigfoot Unity Diabetes Management System FG-300188
FDA UDI
Class IIActive
Bigfoot Unity Diabetes Management System FG-300194
FDA UDI
Class IIActive
Bigfoot Unity Diabetes Management System SW-300842
FDA UDI
Class IIActive
Bigfoot Unity Diabetes Management System FG-300185
FDA UDI
Class IIActive
Bigfoot Unity Diabetes Management System FG-300187
FDA UDI
Class IIActive
Bigfoot Unity FG-301189
FDA UDI
Class IIActive
Bigfoot Unity Diabetes Management System FG-300184
FDA UDI
Class IIActive
Bigfoot Unity FG-300999
FDA UDI
Class IIActive
Bigfoot Unity Diabetes Management System ASM-10049
FDA UDI
Class IIActive
Bigfoot Unity Diabetes Management System FG-300193
FDA UDI
Class IIActive
Bigfoot Unity Diabetes Management System ASM-10043
FDA UDI
Class IIActive
Bigfoot Unity Diabetes Management System ASM-10050
FDA UDI
Class IIActive
Bigfoot Unity FG-301187
FDA UDI
Class IIActive
Bigfoot Unity FG-301184
FDA UDI
Class IIActive
Bigfoot Unity Diabetes Management System FG-300202
FDA UDI
Class IIActive
Bigfoot Unity Diabetes Management System FG-300179
FDA UDI
Class IIActive
Bigfoot Unity Diabetes Management System FG-300177
FDA UDI
Class IIActive
Bigfoot Unity FG-301188
FDA UDI
Class IIActive
Bigfoot Unity Diabetes Management System FG-300196
FDA UDI
Class IIActive
Bigfoot Unity Diabetes Management System FG-300199
FDA UDI
Class IIActive
Bigfoot Unity FG-300998
FDA UDI
Class IIActive
Bigfoot Pen Needles FG-300161
FDA UDI
Class IIActive
Bigfoot Unity FG-301186
FDA UDI
Class IIActive
Bigfoot Unity FG-300996
FDA UDI
Class IIActive
Bigfoot Unity Diabetes Management System ASM-10027
FDA UDI
Class IIActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
May 21, 2025Z-1997-2025—open, classified

Due to a software/firmware issue diabetes management system may provide a device error and cause the insulin pen to become unresponsive and unable to function. This error may pose a potential health risk for people living with diabetes as they may not have all information necessary to make a timely treatment decision.