Where does the data come from?

openFDA device registration and listing endpoint (U.S. Food and Drug Administration). Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm

Isomedix Operations Inc. (contract sterilizer, Spartanburg, SC): 8 new FDA device listings, incl. drills, burrs, trephines & accessories (manual)

Q: How to monitor Isomedix Operations Inc. and peer contract sterilizer records

DeviceEstablishmentPulse lists new DeviceEstablishmentPulse records from openFDA device registration and listing endpoint (U.S. Food and Drug Administration) as they are published; a free weekly email digest and paid alerts follow South Carolina records like this one.

Isomedix Operations Inc. (Spartanburg, South Carolina): 8 new FDA device listings, incl. drills, burrs, trephines & accessories (manual). Its amount of 8 is top-decile (90th percentile of 2,709 records). Dated 22 days ago, it is in the active follow-up window. Score 90/100. As of 2026-11-04, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).

Data as of 2026-11-04 · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)

amount: 8 · 90th percentile of 2,709 DeviceEstablishmentPulse records · 4.0x the median

Free preview: all 15 published fields of this record are shown below. Locked: 15 related SC DeviceEstablishmentPulse records and the 5-column CSV export.

Field	Value
Establishment	Isomedix Operations Inc.
Owner / operator	STERIS Corporation
Role	Contract sterilizer
Establishment types	Sterilize Medical Device for Another Party (Contract Sterilizer); Manufacture Device in the United States for Export Only
Location	Spartanburg, SC, US
New listings	8
Devices	Drills, Burrs, Trephines & Accessories (Manual); Drills, Burrs, Trephines & Accessories (Simple, Powered); Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Catheter, Septostomy; Pump, Infusion, Insulin Bolus; Pump, Infusion, Insulin; Snare, Flexible
Product codes	HBG, HBE, JWH, DXF, OPP, LZG, FDI
Device classes	Class II
Medical specialties	Neurology, Orthopedic, Cardiovascular, General Hospital, Gastroenterology, Urology
Brand names	AdvancedConcept8660 (SP) - Freedom Total Knee System Titanium Tibial Base Plate*; AdvancedConcept8660 (SP) - Freedom TiNbN Coated Knee; US_Endoscopy4223 (SP) - Roth Net retriever select; US_Endoscopy4223 (SP) - Roth Net retriever - 360
First new listing	2026-05-28
Latest new listing	2026-10-14
FDA registration number	1047843
Registration expires	2027-12-31
amount percentile	90th of 2,709 (median 2, 4.0x median)
Peer records CSV (16 SC 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: 2026-10-14
Data refreshed: 2026-11-04
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Top DeviceEstablishmentPulse records (SC first): Isomedix Operations Inc. (contract sterilizer, Spartanburg, · Arthrex Manufacturing Inc. (contract manufacturer, Pendleton · North American Rescue, LLC. (manufacturer, Greer, SC) · NAR Medical Depot, LLC (manufacturer, Greer, SC) · Titanlinks Logistics LLC (repackager or relabeler, Newark, D · 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, 04 Nov 2026 21:52:36 GMT

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Peer benchmark and outreach value: Isomedix Operations Inc. and 16 South Carolina peers

Your role Typical deal size (USD) Assumed reply-to-deal rate (%)

South Carolina DeviceEstablishmentPulse records like this one: 16
Isomedix Operations Inc.'s amount: 90th percentile of 2,709 records
Timing: Medium: dated in the last 30 days
Estimated pipeline if you contact every South Carolina peer: $3,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

90 / 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.
Listed in the last 45 days.

What is the DeviceEstablishmentPulse record for Isomedix Operations Inc. in Spartanburg, South Carolina?

Isomedix Operations Inc. (Spartanburg, SC), a contract sterilizer, added 8 FDA device listings between 2026-05-28 and 2026-10-14.

How does Isomedix Operations Inc. compare to other South Carolina DeviceEstablishmentPulse records?

This is a top-decile record: its amount of 8 is 4.0x the median of 2 across 2,709 records. It is 22 days old, still within a typical 45-day follow-up window. Its Score of 90/100 puts it among the stronger signals in this feed.

Isomedix Operations Inc. vs. top 3 peers

Organization	Location	Amount	Percentile	Record date
Isomedix Operations Inc.	Spartanburg, SC	8	90th	2026-10-14
Isomedix Operations, Inc.	Temecula, CA	8	90th	2026-10-19
Isomedix Operations, Inc	Ontario, CA	7	90th	2026-10-15
Isomedix Operations, Inc.	Libertyville, IL	7	90th	2026-10-15

Compare Isomedix Operations Inc. vs Isomedix Operations Inc. →

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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.