I-Tek Medical, Inc. (contract manufacturer, White Bear Lake, MN): 2 new FDA device listings, incl. cannula, surgical, general & plastic surgery
I-Tek Medical, Inc. (White Bear Lake, Minnesota): 2 new FDA device listings, incl. cannula, surgical, general & plastic surgery. Its amount of 2 is above the median of 2 (69th percentile). Dated 45 days ago, it serves as a historical benchmark. Score 60/100. As of 2026-11-04, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 2 · 69th percentile of 2,709 DeviceEstablishmentPulse records · 1.0x the median
Free preview: all 14 published fields of this record are shown below. Locked: 44 related MN DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | I-Tek Medical, Inc. |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer); Complaint File Establishment per 21 CFR 820.198 |
| Location | White Bear Lake, MN, US |
| New listings | 2 |
| Devices | Cannula, Surgical, General & Plastic Surgery; Dropper, Ent |
| Product codes | GEA, KCM |
| Device classes | Class I |
| Medical specialties | General, Plastic Surgery, Ear, Nose, Throat |
| Brand names | 2-CAN |
| First new listing | 2026-05-19 |
| Latest new listing | 2026-09-21 |
| FDA registration number | 3008627763 |
| Registration expires | 2026-12-31 |
| amount percentile | 69th of 2,709 (median 2, 1.0x median) |
| Peer records CSV (45 MN records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-09-21
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (MN first): Boston Scientific Corporation (manufacturer, Saint Paul, MN) · Isomedix Operations, Inc. (contract sterilizer, Minneapolis, · EPIC MedTec OEM Catheter & Wire LLC (contract manufacturer, · Isomedix Operations, Inc. (contract sterilizer, Minneapolis, · Rms Co. (contract manufacturer, Minneapolis, MN) · Browse all by state and category →
LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 21:52:36 GMT
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Peer benchmark and outreach value: I-Tek Medical, Inc. and 45 Minnesota peers
- Minnesota DeviceEstablishmentPulse records like this one: 45
- I-Tek Medical, Inc.'s amount: 69th percentile of 2,709 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Minnesota peer: $9,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
60 / 100 Score
- Contract manufacturer or sterilizer adding work.
- U.S. establishment.
- Listed in the last 45 days.
What is the DeviceEstablishmentPulse record for I-Tek Medical, Inc. in White Bear Lake, Minnesota?
I-Tek Medical, Inc. (White Bear Lake, MN), a contract manufacturer, added 2 FDA device listings between 2026-05-19 and 2026-09-21.
How does I-Tek Medical, Inc. compare to other Minnesota DeviceEstablishmentPulse records?
Its amount of 2 sits in the upper half (69th percentile) of 2,709 records; the median is 2. It is 45 days old, still within a typical 45-day follow-up window.
I-Tek Medical, Inc. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| I-Tek Medical, Inc. | White Bear Lake, MN | 2 | 69th | 2026-09-21 |
| Tecomet Inc. | Wilmington, MA | 3 | 77th | 2026-10-15 |
| Bard Shannon Limited | Humacao, PR | 3 | 77th | 2026-10-14 |
| Orchid Orthopedic Solutions Oregon, Inc. | Oregon City, OR | 3 | 77th | 2026-10-05 |
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- Karl Storz Endoscopy-America, Inc.
- Orchid Orthopedic Solutions Oregon, Inc.
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DeviceEstablishmentPulse: Contract manufacturer DeviceEstablishmentPulse: U.S. establishment DeviceEstablishmentPulse: records in Minnesota
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From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.