Fiagon Na LLC (manufacturer, Saint Paul, MN): 3 new FDA device listings, incl. balloon, nasal airway
Fiagon Na LLC (Saint Paul, Minnesota): 3 new FDA device listings, incl. balloon, nasal airway. Its amount of 3 is above the median of 1 (77th percentile). Dated 63 days ago, it serves as a historical benchmark. Score 85/100. 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: 3 · 77th percentile of 2,570 DeviceEstablishmentPulse records · 3.0x the median
Free preview: all 15 published fields of this record are shown below. Locked: 42 related MN DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Fiagon Na LLC |
| Owner / operator | Fiagon NA LLC |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | Saint Paul, MN, US |
| New listings | 3 |
| Devices | Balloon, Nasal Airway; Eustachian Tube Balloon Dilation Device; Instrument, Ent Manual Surgical |
| Product codes | QGK, PNZ, LRC |
| Device classes | Class I, Class II |
| Medical specialties | Ear, Nose, Throat |
| Brand names | Shape Nasal Airway Dilation System |
| First new listing | 2026-08-04 |
| Latest new listing | 2026-09-02 |
| FDA registration number | 3025490805 |
| Registration expires | 2026-12-31 |
| amount percentile | 77th of 2,570 (median 1, 3.0x 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: 2026-09-02
- 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: Fiagon Na LLC and 43 Minnesota peers
- Minnesota DeviceEstablishmentPulse records like this one: 43
- Fiagon Na LLC's amount: 77th 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)
85 / 100 Score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.
What is the DeviceEstablishmentPulse record for Fiagon Na LLC in Saint Paul, Minnesota?
Fiagon Na LLC (Saint Paul, MN), a manufacturer, added 3 FDA device listings between 2026-08-04 and 2026-09-02.
How does Fiagon Na LLC compare to other Minnesota DeviceEstablishmentPulse records?
Its amount of 3 sits in the upper half (77th percentile) of 2,570 records; the median is 1. It is 63 days old; check the official source for later updates before acting. Its Score of 85/100 puts it among the stronger signals in this feed.
Fiagon Na LLC vs. top 2 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Fiagon Na LLC | Saint Paul, MN | 3 | 77th | 2026-09-02 |
| Piraeus Medical, Inc. | Maple Grove, MN | 4 | 83rd | 2026-10-12 |
| Boston Scientific Corporation | Saint Paul, MN | 24 | 98th | 2026-10-16 |
Related records
DeviceEstablishmentPulse: 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.