Isomedix Operations Inc. (contract sterilizer, Northborough, MA): 18 new FDA device listings, incl. introducer, catheter
Isomedix Operations Inc. (Northborough, Massachusetts): 18 new FDA device listings, incl. introducer, catheter. Its amount of 18 is top-decile (97th percentile of 2,570 records). Dated 40 days ago, it serves as a historical benchmark. 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: 18 · 97th percentile of 2,570 DeviceEstablishmentPulse records · 18.0x the median
Free preview: all 15 published fields of this record are shown below. Locked: 69 related MA 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 | Northborough, MA, US |
| New listings | 18 |
| Devices | Introducer, Catheter; Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use; Fastener, Fixation, Nondegradable, Soft Tissue; Clamp, Vascular; Screw Sleeve Bone Fixation Device, Spine; Thoracolumbosacral Pedicle Screw System; Hydrogel Spacer; Prosthesis, Vascular Graft, Of Less Then 6mm Diameter; Prosthesis, Vascular Graft, Of 6mm And Greater Diameter; Appliance, Fixation, Spinal Interlaminal |
| Product codes | DYB, JQC, MBI, DXC, QVI, NKB, OVB, DYF, DSY, KWP, KWQ, DQO, NQQ, KWD, OPP |
| Device classes | Class I, Class II |
| Medical specialties | Cardiovascular, Clinical Chemistry, Orthopedic, Radiology, General Hospital |
| Brand names | TerumoMed3380 (NR) -Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding; TerumoMed3380 (NR) - TR Band; TR BAND Radial Compression Device; Woven10921 (NR,CH1*) - Ogmend Implant Enhancement System; Atrium1623 (NR) - Flixene Vascular Graft >6mm; Atrium1623 (NR) - Advanta VXT Vascular Graft >6mm; Atrium1623 (NR) - Flixene Vascular Graft <6mm; Atrium1623 (NR) - Advanta VXT Vascular Graft <6mm; Gentuity7546 (NR) - Gentuity HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter |
| First new listing | 2026-06-01 |
| Latest new listing | 2026-09-25 |
| FDA registration number | 1220477 |
| Registration expires | 2027-12-31 |
| amount percentile | 97th of 2,570 (median 1, 18.0x median) |
| Peer records CSV (70 MA 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: 2026-09-25
- 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 70 Massachusetts peers
- Massachusetts DeviceEstablishmentPulse records like this one: 70
- Isomedix Operations Inc.'s amount: 97th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Massachusetts peer: $14,000 (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 Northborough, Massachusetts?
Isomedix Operations Inc. (Northborough, MA), a contract sterilizer, added 18 FDA device listings between 2026-06-01 and 2026-09-25.
How does Isomedix Operations Inc. compare to other Massachusetts DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 18 is 18.0x the median of 1 across 2,570 records. It is 40 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. | Northborough, MA | 18 | 97th | 2026-09-25 |
| Isomedix Operations, Inc. | Minneapolis, MN | 12 | 95th | 2026-10-14 |
| C.R. Bard, Inc. | Madison, GA | 10 | 93rd | 2026-10-14 |
| Sterigenics US LLC | Los Angeles, CA | 8 | 91st | 2026-09-30 |
Related records
DeviceEstablishmentPulse: Contract sterilizer DeviceEstablishmentPulse: U.S. establishment DeviceEstablishmentPulse: records in Massachusetts
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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.