Sterigenics U.S., LLC (contract sterilizer, Atlanta, GA): 10 new FDA device listings, incl. prosthesis, ankle, semi-constrained, cemented, metal/polymer
Sterigenics U.S., LLC (Atlanta, Georgia): 10 new FDA device listings, incl. prosthesis, ankle, semi-constrained, cemented, metal/polymer. Its amount of 10 is top-decile (93rd percentile of 2,570 records). Dated 153 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: 10 · 93th percentile of 2,570 DeviceEstablishmentPulse records · 10.0x the median
Free preview: all 15 published fields of this record are shown below. Locked: 42 related GA 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 | Atlanta, GA, US |
| New listings | 10 |
| Devices | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer; Prosthesis, Toe, Constrained, Polymer; Fastener, Fixation, Nondegradable, Soft Tissue; Arthroscope |
| Product codes | HSN, KWH, MBI, HRX |
| Device classes | Class II |
| Medical specialties | Orthopedic |
| Brand names | Cadence Total Ankle System; Silicone Toe System - CGT; Morphix XT; 8.4MM/50MM CANNULA 10 EA; 8.4MM/75MM CANNULA 10 EA; 6MM/75MM CANNULA 10 EA; TRUSHOT WITH Y-KNOT 1.8MM ALL-SUTURE ANCHOR WITH TWO NO.2 (5 METRIC) HI-FI SUTURE WITH NEEDLES; TRUSHOT WITH Y-KNOT 1.3MM ALL-SUTURE ANCHOR WITH ONE NO.2 (5 METRIC) HI-FI SUTURE WITH NEEDLES |
| First new listing | 2026-05-21 |
| Latest new listing | 2026-06-04 |
| FDA registration number | 1018470 |
| Registration expires | 2026-12-31 |
| amount percentile | 93th of 2,570 (median 1, 10.0x median) |
| Peer records CSV (43 GA 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: 2026-06-04
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (GA first): Drive Northpoint, LLC (manufacturer, Palmetto, GA) · Hsg-S Corp (manufacturer, Savannah, GA) · C.R. Bard, Inc. (contract sterilizer, Covington, GA) · Emsere, Inc. (repackager or relabeler, Peachtree City, GA) · O&M Halyard, Inc. (manufacturer, Alpharetta, GA) · 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 43 Georgia peers
- Georgia DeviceEstablishmentPulse records like this one: 43
- Sterigenics U.S., LLC's amount: 93rd percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Georgia peer: $8,600 (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 Atlanta, Georgia?
Sterigenics U.S., LLC (Atlanta, GA), a contract sterilizer, added 10 FDA device listings between 2026-05-21 and 2026-06-04.
How does Sterigenics U.S., LLC compare to other Georgia DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 10 is 10.0x the median of 1 across 2,570 records. It is 153 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 3 peers
| Organization | Location | Amount | Percentile | Record date | Compare |
|---|---|---|---|---|---|
| Sterigenics U.S., LLC | Atlanta, GA | 10 | 93rd | 2026-06-04 | This record |
| C.R. Bard, Inc. | Madison, GA | 10 | 93rd | 2026-10-14 | Compare Sterigenics U.S., LLC vs C.R. Bard, Inc. → |
| Isomedix Operations Inc. | Spartanburg, SC | 8 | 91st | 2026-10-14 | View record → |
| Isomedix Operations, Inc. | Minneapolis, MN | 12 | 95th | 2026-10-14 | View record → |
Related records
DeviceEstablishmentPulse: Contract sterilizer DeviceEstablishmentPulse: U.S. establishment DeviceEstablishmentPulse: records in Georgia
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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.