Isomedix Operations, Inc. (contract sterilizer, Temecula, CA): 7 new FDA device listings, incl. percutaneous catheter, ultrasound
Isomedix Operations, Inc. (Temecula, California): 7 new FDA device listings, incl. percutaneous catheter, ultrasound. Its amount of 7 is top-decile (90th percentile of 2,570 records). Dated 21 days ago, it is in the active follow-up window. Score 90/100. 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 15 published fields of this record are shown below. Locked: 283 related CA 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) |
| Location | Temecula, CA, US |
| New listings | 7 |
| Devices | Percutaneous Catheter, Ultrasound; Catheter, Retention Type, Balloon; Stylet, Catheter; Catheter, Electrode Recording, Or Probe, Electrode Recording; Stimulator, Spinal-Cord, Implanted (Pain Relief); Stimulator, Spinal-Cord, Totally Implanted For Pain Relief; Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy |
| Product codes | PPN, EZL, DRB, DRF, GZB, LGW, QRB |
| Device classes | Class II, Class III |
| Medical specialties | Cardiovascular, Gastroenterology, Urology, Neurology |
| Brand names | Merit1383 (TM) - Bulldog Lead Extender |
| First new listing | 2026-06-05 |
| Latest new listing | 2026-10-14 |
| FDA registration number | 2030624 |
| Registration expires | 2027-12-31 |
| amount percentile | 90th of 2,570 (median 1, 7.0x median) |
| Peer records CSV (284 CA 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: 2026-10-28
- 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: Isomedix Operations, Inc. and 284 California peers
- California DeviceEstablishmentPulse records like this one: 284
- Isomedix Operations, Inc.'s amount: 90th percentile of 2,570 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every California peer: $56,800 (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 Temecula, California?
Isomedix Operations, Inc. (Temecula, CA), a contract sterilizer, added 7 FDA device listings between 2026-06-05 and 2026-10-14.
How does Isomedix Operations, Inc. compare to other California 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 21 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 2 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Isomedix Operations, Inc. | Temecula, CA | 7 | 90th | 2026-10-14 |
| Isomedix Operations, Inc | Ontario, CA | 7 | 90th | 2026-10-15 |
| Sterigenics US LLC | Los Angeles, CA | 8 | 91st | 2026-09-30 |
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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.