Stephens Instruments, Inc (repackager or relabeler, Lexington, KY): 13 new FDA device listings, incl. spoon, ophthalmic
Stephens Instruments, Inc (Lexington, Kentucky): 13 new FDA device listings, incl. spoon, ophthalmic. Its amount of 13 is top-decile (95th percentile of 2,570 records). Dated 126 days ago, it serves as a historical benchmark. Score 65/100. 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: 13 · 95th percentile of 2,570 DeviceEstablishmentPulse records · 13.0x the median
Free preview: all 15 published fields of this record are shown below. Locked: 5 related KY DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Stephens Instruments, Inc |
| Owner / operator | Stephens Instruments, Inc. |
| Role | Repackager or relabeler |
| Establishment types | Repack or Relabel Medical Device |
| Location | Lexington, KY, US |
| New listings | 13 |
| Devices | Spoon, Ophthalmic; Clip, Tantalum, Ophthalmic; Marker, Ocular; Holder, Needle, Gastroenterologic; Handle, Scalpel; Needle, Aspiration And Injection, Reusable; Dissector, Surgical, General & Plastic Surgery; Instrument, Measuring, Corneal Radius; Unit, Syringe, Air And/Or Water; Forceps |
| Product codes | HNB, HQW, HMR, FHQ, GDZ, GDM, GDI, HJB, ECB, HTD, OHW, HOD, HOG |
| Device classes | Class I, Class II |
| Medical specialties | Ophthalmic, Gastroenterology, Urology, General, Plastic Surgery, Dental |
| Brand names | Ophthalmic Spoon; Clip, Tantalum, Ophthalmic; Ocular Marker; Needle Holder; Scalpel; Aspiration Needle; Dissector; Corneal radius measurement instrument |
| First new listing | 2026-06-03 |
| Latest new listing | 2026-07-01 |
| FDA registration number | 1045379 |
| Registration expires | 2027-12-31 |
| amount percentile | 95th of 2,570 (median 1, 13.0x median) |
| Peer records CSV (6 KY 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: 2026-07-01
- 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: Stephens Instruments, Inc and 6 Kentucky peers
- Kentucky DeviceEstablishmentPulse records like this one: 6
- Stephens Instruments, Inc's amount: 95th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Kentucky peer: $1,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
65 / 100 Score
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.
What is the DeviceEstablishmentPulse record for Stephens Instruments, Inc in Lexington, Kentucky?
Stephens Instruments, Inc (Lexington, KY), a repackager or relabeler, added 13 FDA device listings between 2026-06-03 and 2026-07-01.
How does Stephens Instruments, Inc compare to other Kentucky DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 13 is 13.0x the median of 1 across 2,570 records. It is 126 days old; check the official source for later updates before acting.
Stephens Instruments, Inc vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Stephens Instruments, Inc | Lexington, KY | 13 | 95th | 2026-07-01 |
| Karl Storz Endoscopy-America, Inc. | Auburn, MA | 14 | 96th | 2026-09-28 |
| VIVE Health LLC | Naples, FL | 10 | 93rd | 2026-10-14 |
| Tpc Advanced Technology, Inc. | City Industry, CA | 4 | 83rd | 2026-09-28 |
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DeviceEstablishmentPulse: Repackager or relabeler DeviceEstablishmentPulse: U.S. establishment DeviceEstablishmentPulse: records in Kentucky
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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.