MedtechSourcebook

I-Tek Medical, Inc.

Contract manufacturer and sterilizer ยท White Bear Lake, MN

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

2014Product codes first listed, by year (tallest: 7)2026
FDA registration
3008627763 (openFDA record; or search FDA's registration database)
FEI number
3008627763
Registered for
FDA registration year 2026
Establishment types
Complaint file establishment; Manufacturer; Contract manufacturer; Contract sterilizer
Owner or operator
I-Tek Medical, Inc. (FDA owner/operator no. 10047604)
Registered address
1837 Buerkle Rd, White Bear Lake, MN 55110
Contract listings
13 device listings, 15 product codes, first listed Oct 10, 2014
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
DQXWire, Guide, CatheterClass IICardiovascularContract manufacturingOct 10, 2014
DQYCatheter, PercutaneousClass IICardiovascularContract manufacturingOct 10, 2014
DXXSystem, Catheter Control, SteerableClass IICardiovascularContract manufacturingOct 10, 2014
FDGRetractor, FiberopticClass IGastroenterology and urologyContract manufacturingOct 10, 2014
FDSGastroscope And Accessories, Flexible/RigidClass IIGastroenterology and urologyContract manufacturingSep 16, 2022
GEACannula, Surgical, General & Plastic SurgeryClass IGeneral and plastic surgeryContract manufacturingSep 21, 2026
GEXPowered Laser Surgical InstrumentClass IIGeneral and plastic surgeryContract manufacturingOct 10, 2014
HAWNeurological Stereotaxic InstrumentClass IINeurologyContract manufacturingOct 10, 2014
ITXTransducer, Ultrasonic, DiagnosticClass IIRadiologyContract manufacturingSep 16, 2022
IWWShield, VialClass IRadiologyContract manufacturingMar 14, 2017
KDDKit, Surgical Instrument, DisposableClass IGeneral and plastic surgeryContract sterilizationJul 13, 2023
LXHOrthopedic Manual Surgical InstrumentClass IOrthopedicContract manufacturingMar 20, 2026
MJNCatheter, Intravascular Occluding, TemporaryClass IICardiovascularContract manufacturingOct 10, 2014
NEUMarker, Radiographic, ImplantableClass IIGeneral and plastic surgeryContract manufacturingDec 30, 2021
OTNMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or TransobturatorClass IIGeneral and plastic surgeryContract manufacturingDec 20, 2023