Axion USA LLC (specification developer, Carteret, NJ): 1 new FDA device listing, incl. stimulator, electrical, non-implantable, for incontinence
Axion USA LLC (Carteret, New Jersey): 1 new FDA device listing, incl. stimulator, electrical, non-implantable, for incontinence. Its amount of 1 is above the median of 1 (50th percentile). Dated 145 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: 1 · 50th percentile of 2,570 DeviceEstablishmentPulse records · 1.0x the median
Free preview: all 15 published fields of this record are shown below. Locked: 48 related NJ DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Axion USA LLC |
| Owner / operator | Axion USA |
| Role | Specification developer (outsources manufacturing) |
| Establishment types | Develop Specifications But Do Not Manufacture At This Facility |
| Location | Carteret, NJ, US |
| New listings | 1 |
| Devices | Stimulator, Electrical, Non-Implantable, For Incontinence |
| Product codes | KPI |
| Device classes | Class II |
| Medical specialties | Gastroenterology, Urology |
| Brand names | Pelvic Floor Trainer STIM-PRO I-3000 |
| First new listing | 2026-06-12 |
| Latest new listing | 2026-06-12 |
| FDA registration number | 3027329006 |
| Registration expires | 2026-12-31 |
| amount percentile | 50th of 2,570 (median 1, 1.0x median) |
| Peer records CSV (49 NJ 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: 2026-06-12
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
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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: Axion USA LLC and 49 New Jersey peers
- New Jersey DeviceEstablishmentPulse records like this one: 49
- Axion USA LLC's amount: 50th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every New Jersey peer: $9,800 (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.
- Class II or III devices: QMS and regulatory demands.
- U.S. establishment.
What is the DeviceEstablishmentPulse record for Axion USA LLC in Carteret, New Jersey?
Axion USA LLC (Carteret, NJ), a specification developer (outsources manufacturing), added 1 FDA device listing on 2026-06-12.
How does Axion USA LLC compare to other New Jersey DeviceEstablishmentPulse records?
Its amount of 1 sits in the upper half (50th percentile) of 2,570 records; the median is 1. It is 145 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.
Axion USA LLC vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Axion USA LLC | Carteret, NJ | 1 | 50th | 2026-06-12 |
| Davol Inc., Sub. C.R. Bard, Inc. | Warwick, RI | 3 | 77th | 2026-10-14 |
| Ge Medical Systems, LLC | Waukesha, WI | 3 | 77th | 2026-10-06 |
| Align Technology, Inc. | San Jose, CA | 3 | 77th | 2026-09-30 |
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DeviceEstablishmentPulse: Specification developer (outsources manufacturing) DeviceEstablishmentPulse: U.S. establishment DeviceEstablishmentPulse: records in New Jersey
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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.