Isomedix Operations, Inc. (contract sterilizer, Minneapolis, MN): 16 new FDA device listings, incl. electrosurgical, cutting & coagulation & accessories

Isomedix Operations, Inc. (Minneapolis, Minnesota): 16 new FDA device listings, incl. electrosurgical, cutting & coagulation & accessories. Its amount of 16 is top-decile (96th percentile of 2,709 records). Dated 15 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 · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)

amount: 16 · 96th percentile of 2,709 DeviceEstablishmentPulse records · 8.0x the median

Free preview: all 15 published fields of this record are shown below. Locked: 44 related MN DeviceEstablishmentPulse records and the 5-column CSV export.

FieldValue
EstablishmentIsomedix Operations, Inc.
Owner / operatorSTERIS Corporation
RoleContract sterilizer
Establishment typesSterilize Medical Device for Another Party (Contract Sterilizer); Manufacture Device in the United States for Export Only
LocationMinneapolis, MN, US
New listings16
DevicesElectrosurgical, Cutting & Coagulation & Accessories; Device, Vascular, For Promoting Embolization; Catheter, Percutaneous; Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System; Syringe, Antistick; Needle, Hypodermic, Single Lumen; Syringe, Piston; Electrode, Depth; Intervertebral Body Graft Containment Device; Negative Pressure Wound Therapy Powered Suction Pump
Product codesGEI, KRD, DQY, ONB, MEG, FMI, FMF, GZL, OQB, OMP, KNQ, FGE
Device classesClass II
Medical specialtiesGeneral, Plastic Surgery, Cardiovascular, General Hospital, Neurology, Orthopedic, Gastroenterology, Urology
Brand namesOlympus2295 (MN) - POWERSEAL OPEN EXTENDED JAW; AbbottStructural (MN) - Amplatzer Valvular Plug III; AbbottStructural (MN) - Amplatzer TorqVue Exchange System; Spineology5627 (MN) - OptiMesh HA Nano Multiplanar Expandable Interbody Fusion; AbbottStructural (MN) - Amplatzer TorqVue LP Catheter; AbbottStructural (MN) - Amplatzer TorqVue LP Delivery System; AbbottStructural (MN) - Amplatzer Piccolo Delivery System; AbbottStructural (MN) - Amplatzer TorqVue Delivery System
First new listing2026-05-29
Latest new listing2026-10-21
FDA registration number2183744
Registration expires2027-12-31
amount percentile96th of 2,709 (median 2, 8.0x median)
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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: 2026-10-21
  • Data refreshed: 2026-11-04
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Top DeviceEstablishmentPulse records (MN first): Boston Scientific Corporation (manufacturer, Saint Paul, MN) · EPIC MedTec OEM Catheter & Wire LLC (contract manufacturer, · Isomedix Operations, Inc. (contract sterilizer, Minneapolis, · Rms Co. (contract manufacturer, Minneapolis, MN) · Boston Scientific Corporation (specification developer, Mapl · 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 45 Minnesota peers

  • Minnesota DeviceEstablishmentPulse records like this one: 45
  • Isomedix Operations, Inc.'s amount: 96th percentile of 2,709 records
  • Timing: Medium: dated in the last 30 days
  • Estimated pipeline if you contact every Minnesota peer: $9,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

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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 Minneapolis, Minnesota?

Isomedix Operations, Inc. (Minneapolis, MN), a contract sterilizer, added 16 FDA device listings between 2026-05-29 and 2026-10-21.

How does Isomedix Operations, Inc. compare to other Minnesota DeviceEstablishmentPulse records?

This is a top-decile record: its amount of 16 is 8.0x the median of 2 across 2,709 records. It is 15 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

OrganizationLocationAmountPercentileRecord date
Isomedix Operations, Inc.Minneapolis, MN1696th2026-10-21
Isomedix Operations Inc.Sandy, UT1395th2026-10-15
Isomedix Operations Inc.Spartanburg, SC1193rd2026-10-19
C.R. Bard, Inc.Madison, GA1092nd2026-10-14

Related records

DeviceEstablishmentPulse: Contract sterilizer DeviceEstablishmentPulse: U.S. establishment DeviceEstablishmentPulse: records in Minnesota

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FdaApprovalPulse: records in Minnesota (61)

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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.

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