Contract manufacturerContract sterilizerI-Tek Medical, Inc. (White Bear Lake, MN)MinnesotaCardiovascularGastroenterology and urologyGeneral and plastic surgeryNeurologyRadiologyOrthopedicClass IIClass I
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
- 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 code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| DQX | Wire, Guide, Catheter | Class II | Cardiovascular | Contract manufacturing | Oct 10, 2014 |
| DQY | Catheter, Percutaneous | Class II | Cardiovascular | Contract manufacturing | Oct 10, 2014 |
| DXX | System, Catheter Control, Steerable | Class II | Cardiovascular | Contract manufacturing | Oct 10, 2014 |
| FDG | Retractor, Fiberoptic | Class I | Gastroenterology and urology | Contract manufacturing | Oct 10, 2014 |
| FDS | Gastroscope And Accessories, Flexible/Rigid | Class II | Gastroenterology and urology | Contract manufacturing | Sep 16, 2022 |
| GEA | Cannula, Surgical, General & Plastic Surgery | Class I | General and plastic surgery | Contract manufacturing | Sep 21, 2026 |
| GEX | Powered Laser Surgical Instrument | Class II | General and plastic surgery | Contract manufacturing | Oct 10, 2014 |
| HAW | Neurological Stereotaxic Instrument | Class II | Neurology | Contract manufacturing | Oct 10, 2014 |
| ITX | Transducer, Ultrasonic, Diagnostic | Class II | Radiology | Contract manufacturing | Sep 16, 2022 |
| IWW | Shield, Vial | Class I | Radiology | Contract manufacturing | Mar 14, 2017 |
| KDD | Kit, Surgical Instrument, Disposable | Class I | General and plastic surgery | Contract sterilization | Jul 13, 2023 |
| LXH | Orthopedic Manual Surgical Instrument | Class I | Orthopedic | Contract manufacturing | Mar 20, 2026 |
| MJN | Catheter, Intravascular Occluding, Temporary | Class II | Cardiovascular | Contract manufacturing | Oct 10, 2014 |
| NEU | Marker, Radiographic, Implantable | Class II | General and plastic surgery | Contract manufacturing | Dec 30, 2021 |
| OTN | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | Class II | General and plastic surgery | Contract manufacturing | Dec 20, 2023 |