Sterigenics U.S., LLC (contract sterilizer, Schaumburg, IL): 7 new FDA device listings, incl. intervertebral fusion device with bone graft, lumbar
Sterigenics U.S., LLC (Schaumburg, Illinois): 7 new FDA device listings, incl. intervertebral fusion device with bone graft, lumbar. Its amount of 7 is top-decile (90th percentile of 2,570 records). Dated 132 days ago, it serves as a historical benchmark. Score 80/100. 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: 7 · 90th percentile of 2,570 DeviceEstablishmentPulse records · 7.0x the median
Free preview: all 14 published fields of this record are shown below. Locked: 94 related IL DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Sterigenics U.S., LLC |
| Owner / operator | Sotera Health LLC |
| Role | Contract sterilizer |
| Establishment types | Sterilize Medical Device for Another Party (Contract Sterilizer) |
| Location | Schaumburg, IL, US |
| New listings | 7 |
| Devices | Intervertebral Fusion Device With Bone Graft, Lumbar; Appliance, Fixation, Spinal Intervertebral Body; Powered Laser Surgical Instrument |
| Product codes | MAX, KWQ, GEX |
| Device classes | Class II |
| Medical specialties | Orthopedic, General, Plastic Surgery |
| First new listing | 2026-05-13 |
| Latest new listing | 2026-06-25 |
| FDA registration number | 1420032 |
| Registration expires | 2026-12-31 |
| amount percentile | 90th of 2,570 (median 1, 7.0x median) |
| Peer records CSV (95 IL 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: 2026-06-25
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (IL first): MEDLINE INDUSTRIES, LP - Northfield (specification developer · Isomedix Operations, Inc. (contract sterilizer, Libertyville · Icu Medical, Inc. (specification developer, Lake Forest, IL) · Maya Medical Top Trade Ltd. (foreign exporter, Tsofit Centra · Sterigenics US LLC (contract sterilizer, Gurnee, IL) · 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: Sterigenics U.S., LLC and 95 Illinois peers
- Illinois DeviceEstablishmentPulse records like this one: 95
- Sterigenics U.S., LLC's amount: 90th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Illinois peer: $19,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
80 / 100 Score
- Contract manufacturer or sterilizer adding work.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.
What is the DeviceEstablishmentPulse record for Sterigenics U.S., LLC in Schaumburg, Illinois?
Sterigenics U.S., LLC (Schaumburg, IL), a contract sterilizer, added 7 FDA device listings between 2026-05-13 and 2026-06-25.
How does Sterigenics U.S., LLC compare to other Illinois DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 7 is 7.0x the median of 1 across 2,570 records. It is 132 days old; check the official source for later updates before acting. Its Score of 80/100 puts it among the stronger signals in this feed.
Sterigenics U.S., LLC vs. top 2 peers
| Organization | Location | Amount | Percentile | Record date | Compare |
|---|---|---|---|---|---|
| Sterigenics U.S., LLC | Schaumburg, IL | 7 | 90th | 2026-06-25 | This record |
| Isomedix Operations, Inc. | Libertyville, IL | 7 | 90th | 2026-10-15 | Compare Sterigenics U.S., LLC vs Isomedix Operations, Inc. → |
| Isomedix Operations, Inc. | Libertyville, IL | 124 | 99th | 2026-10-14 | View record → |
Related records
DeviceEstablishmentPulse: Contract sterilizer DeviceEstablishmentPulse: U.S. establishment DeviceEstablishmentPulse: records in Illinois
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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.