Sterigenics US, LLC (contract sterilizer, Lewis Center, OH): 38 new FDA device listings, incl. injector and syringe, angiographic
Sterigenics US, LLC (Lewis Center, Ohio): 38 new FDA device listings, incl. injector and syringe, angiographic. Its amount of 38 is top-decile (99th percentile of 2,570 records). Dated 71 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: 38 · 99th percentile of 2,570 DeviceEstablishmentPulse records · 38.0x the median
Free preview: all 15 published fields of this record are shown below. Locked: 41 related OH DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Sterigenics US, LLC |
| Owner / operator | Sotera Health LLC |
| Role | Contract sterilizer |
| Establishment types | Sterilize Medical Device for Another Party (Contract Sterilizer) |
| Location | Lewis Center, OH, US |
| New listings | 38 |
| Devices | Injector And Syringe, Angiographic; Injector, Contrast Medium, Automatic; Orthopedic Augmented Reality; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented; Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing |
| Product codes | DXT, IZQ, SBF, MBL, LPH, OQG, LZO, KRO, JDI, NRA, MAX, KWZ, MEH, LWJ, KWY |
| Device classes | Class II, Class III |
| Medical specialties | Cardiovascular, Neurology, Orthopedic |
| Brand names | MEDRAD® Centargo Day Set (CENT-DS); Zimmer Biomet OSS Orthopedic Salvage System OsseoTi Sleeves and Augments; Oxford Vivacit-E Bearings; Symmetrix L Spinal System; Z1 Hip System; CD Horizon ModuLeX FNS Screw Set with nanoLOCK; CD Horizon ModuLeX Spinal System with nanoLOCK; Screws and Navigated Instruments |
| First new listing | 2026-05-13 |
| Latest new listing | 2026-08-26 |
| FDA registration number | 1526534 |
| Registration expires | 2026-12-31 |
| amount percentile | 99th of 2,570 (median 1, 38.0x median) |
| Peer records CSV (42 OH 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: 2026-08-26
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (OH first): Aps Materials, Inc. (contract manufacturer, Dayton, OH) · Health Care Logistics, Inc. (repackager or relabeler, Urbanc · Hammill Mfg. Co. (contract manufacturer, Maumee, OH) · Guardian Medical USA, Inc (contract manufacturer, Swanton, O · Neoconcepts LLC (other, Lewis Center, OH) · 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 US, LLC and 42 Ohio peers
- Ohio DeviceEstablishmentPulse records like this one: 42
- Sterigenics US, LLC's amount: 99th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Ohio peer: $8,400 (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 US, LLC in Lewis Center, Ohio?
Sterigenics US, LLC (Lewis Center, OH), a contract sterilizer, added 38 FDA device listings between 2026-05-13 and 2026-08-26.
How does Sterigenics US, LLC compare to other Ohio DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 38 is 38.0x the median of 1 across 2,570 records. It is 71 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 US, LLC vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Sterigenics US, LLC | Lewis Center, OH | 38 | 99th | 2026-08-26 |
| Isomedix Operations Inc. | Whippany, NJ | 26 | 98th | 2026-09-28 |
| Isomedix Operations Inc. | S Plainfield, NJ | 16 | 96th | 2026-09-28 |
| Isomedix Operations Inc. | Sandy, UT | 13 | 95th | 2026-10-15 |
Related records
DeviceEstablishmentPulse: Contract sterilizer DeviceEstablishmentPulse: U.S. establishment DeviceEstablishmentPulse: records in Ohio
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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.