Sxwell USA LLC (specification developer, New York, NY): 4 new FDA device listings, incl. lubricant, personal
Sxwell USA LLC (New York, New York): 4 new FDA device listings, incl. lubricant, personal. Its amount of 4 is above the median of 1 (83rd percentile). Dated 52 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: 4 · 83th percentile of 2,570 DeviceEstablishmentPulse records · 4.0x the median
Free preview: all 15 published fields of this record are shown below. Locked: 55 related NY DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Sxwell USA LLC |
| Owner / operator | Sxwell USA LLC. |
| Role | Specification developer (outsources manufacturing) |
| Establishment types | Develop Specifications But Do Not Manufacture At This Facility |
| Location | New York, NY, US |
| New listings | 4 |
| Devices | Lubricant, Personal |
| Product codes | NUC |
| Device classes | Class II |
| Medical specialties | Obstetrics/Gynecology |
| Brand names | SKYN ULTRA THICK ANAL LUBE; SKYN PURE LUBE; SKYN STRAWBERRY LUBRICANT; SKYN SILICONE LUBE |
| First new listing | 2026-09-14 |
| Latest new listing | 2026-09-14 |
| FDA registration number | 3013388459 |
| Registration expires | 2026-12-31 |
| amount percentile | 83th of 2,570 (median 1, 4.0x median) |
| Peer records CSV (56 NY 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: 2026-09-14
- 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: Sxwell USA LLC and 56 New York peers
- New York DeviceEstablishmentPulse records like this one: 56
- Sxwell USA LLC's amount: 83rd percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every New York peer: $11,200 (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 Sxwell USA LLC in New York, New York?
Sxwell USA LLC (New York, NY), a specification developer (outsources manufacturing), added 4 FDA device listings on 2026-09-14.
How does Sxwell USA LLC compare to other New York DeviceEstablishmentPulse records?
Its amount of 4 sits in the upper half (83th percentile) of 2,570 records; the median is 1. It is 52 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.
Sxwell USA LLC vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Sxwell USA LLC | New York, NY | 4 | 83rd | 2026-09-14 |
| 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 |
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- 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 New York
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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.