MedtechSourcebook

Innovize

Contract manufacturer · North Oaks, MN

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

FDA registration
2135339 (openFDA record; or search FDA's registration database)
FEI number
3007867940
Registered for
FDA registration year 2026
Establishment types
Contract manufacturer
Owner or operator
Innovize (FDA owner/operator no. 10026450)
Registered address
500 Oak Grove Parkway, North Oaks, MN 55127
Contract listings
16 device listings, 13 product codes, first listed Feb 13, 2013
Certification
Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product codeDevice (FDA name)ClassCategoryRoleFirst listed
FRODressing, Wound, DrugUnclassifiedGeneral and plastic surgeryContract manufacturingApr 30, 2021
FZZMarker, SkinClass IGeneral and plastic surgeryContract manufacturingApr 30, 2015
GXYElectrode, CutaneousClass IINeurologyContract manufacturingJun 25, 2014
HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)Class IOphthalmicContract manufacturingJun 20, 2014
HXTTape, OrthopedicClass IGeneral and plastic surgeryContract manufacturingJan 12, 2023
KGXTape And Bandage, AdhesiveClass IGeneral hospitalContract manufacturingFeb 13, 2013
LYASplint, Intranasal SeptalClass IEar, nose and throatContract manufacturingSep 27, 2016
NADDressing, Wound, OcclusiveClass IGeneral and plastic surgeryContract manufacturingNov 18, 2014
NKJCushion, Pad, Denture, Wax Impregnated Cotton, Over The CounterClass IDentalContract manufacturingApr 18, 2019
OLROral Wound DressingUnclassifiedDentalContract manufacturingJan 12, 2015
QCDContinuous Glucose Monitor, Implanted, Adjunctive UseClass IIIClinical chemistryContract manufacturingJan 17, 2019
QPXNegative Pressure Wound Therapy, Non-Powered Suction Pump, ChemicalClass IIGeneral and plastic surgeryContract manufacturingNov 9, 2021
QSYHemostatic Wound Dressing Without Thrombin Or Other BiologicsUnclassifiedGeneral and plastic surgeryContract manufacturingJun 25, 2014