EarGear LLC (specification developer, Eden Prairie, MN): 4 new FDA device listings, incl. prosthesis, adhesive, external
EarGear LLC (Eden Prairie, Minnesota): 4 new FDA device listings, incl. prosthesis, adhesive, external. Its amount of 4 is above the median of 1 (83rd percentile). Dated 125 days ago, it serves as a historical benchmark. Score 70/100. As of 2026-10-28, 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: 4 · 83th percentile of 2,570 DeviceEstablishmentPulse records · 4.0x the median
Free preview: all 14 published fields of this record are shown below. Locked: 42 related MN DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | EarGear LLC |
| Role | Specification developer (outsources manufacturing) |
| Establishment types | Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility |
| Location | Eden Prairie, MN, US |
| New listings | 4 |
| Devices | Prosthesis, Adhesive, External; Plastic Surgery And Accessories Kit; Material, External Aesthetic Restoration, No Adhesive; Splint, Extremity, Non-Inflatable, External, Non-Sterile |
| Product codes | GBJ, FTN, NOK, NOC |
| Device classes | Class I |
| Medical specialties | General, Plastic Surgery |
| Brand names | EarGear; EarGear Molding System; EarGear Otoputty |
| First new listing | 2026-06-29 |
| Latest new listing | 2026-07-02 |
| FDA registration number | 3047515274 |
| Registration expires | 2026-12-31 |
| amount percentile | 83th of 2,570 (median 1, 4.0x median) |
| Peer records CSV (43 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: 2026-07-02
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (MN first): Boston Scientific Corporation (manufacturer, Saint Paul, MN) · EPIC MedTec OEM Catheter & Wire LLC (contract manufacturer, · Isomedix Operations, Inc. (contract sterilizer, Minneapolis, · Rms Co. (contract manufacturer, Minneapolis, MN) · Boston Scientific Corporation (specification developer, Mapl · 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, 28 Oct 2026 20:51:27 GMT
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Peer benchmark and outreach value: EarGear LLC and 43 Minnesota peers
- Minnesota DeviceEstablishmentPulse records like this one: 43
- EarGear LLC's amount: 83rd percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Minnesota peer: $8,600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
70 / 100 Score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Several new listings at once.
- U.S. establishment.
What is the DeviceEstablishmentPulse record for EarGear LLC in Eden Prairie, Minnesota?
EarGear LLC (Eden Prairie, MN), a specification developer (outsources manufacturing), added 4 FDA device listings between 2026-06-29 and 2026-07-02.
How does EarGear LLC compare to other Minnesota DeviceEstablishmentPulse records?
Its amount of 4 sits in the upper half (83th percentile) of 2,570 records; the median is 1. It is 125 days old; check the official source for later updates before acting. Its Score of 70/100 puts it among the stronger signals in this feed.
EarGear LLC vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| EarGear LLC | Eden Prairie, MN | 4 | 83rd | 2026-07-02 |
| Alc Enterprises Inc | Brooklyn, NY | 4 | 83rd | 2026-10-18 |
| Deka Research & Development Corp. | Manchester, NH | 4 | 83rd | 2026-09-25 |
| Davol Inc., Sub. C.R. Bard, Inc. | Warwick, RI | 3 | 77th | 2026-10-14 |
Related records
- Alc Enterprises Inc
- Boston Scientific Corporation
- SHOULDER INNOVATIONS, Inc
- Davol Inc., Sub. C.R. Bard, Inc.
- MEDLINE INDUSTRIES, LP - Northfield
- Ge Medical Systems, LLC
- Align Technology, Inc.
- Orthopediatrics, Corp
- Sol-Millennium Medical, Inc.
- Wright Medical Technology, Inc.
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- Deka Research & Development Corp.
DeviceEstablishmentPulse: Specification developer (outsources manufacturing) 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.