Ontogen Manufacturing LLC (contract manufacturer, Lisle, IL): 5 new FDA device listings, incl. adaptor, ureteral catheter

Ontogen Manufacturing LLC (Lisle, Illinois): 5 new FDA device listings, incl. adaptor, ureteral catheter. Its amount of 5 is above the median of 1 (87th percentile). Dated 65 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: 5 · 87th percentile of 2,570 DeviceEstablishmentPulse records · 5.0x the median

Free preview: all 13 published fields of this record are shown below. Locked: 94 related IL DeviceEstablishmentPulse records and the 5-column CSV export.

FieldValue
EstablishmentOntogen Manufacturing LLC
RoleContract manufacturer
Establishment typesManufacture Medical Device for Another Party (Contract Manufacturer)
LocationLisle, IL, US
New listings5
DevicesAdaptor, Ureteral Catheter; Plethysmograph, Photoelectric, Pneumatic Or Hydraulic; Ballistocardiograph; Electrocardiograph; Transmitters And Receivers, Physiological Signal, Radiofrequency
Product codesEYI, JOM, DXR, DPS, DRG
Device classesClass I, Class II
Medical specialtiesGastroenterology, Urology, Cardiovascular
First new listing2026-05-15
Latest new listing2026-08-31
FDA registration number3038472982
Registration expires2026-12-31
amount percentile87th of 2,570 (median 1, 5.0x 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: 2026-08-31
  • 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: Ontogen Manufacturing LLC and 95 Illinois peers

  • Illinois DeviceEstablishmentPulse records like this one: 95
  • Ontogen Manufacturing LLC's amount: 87th percentile of 2,570 records
  • Timing: Low: older than 30 days
  • Estimated pipeline if you contact every Illinois peer: $19,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

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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 Ontogen Manufacturing LLC in Lisle, Illinois?

Ontogen Manufacturing LLC (Lisle, IL), a contract manufacturer, added 5 FDA device listings between 2026-05-15 and 2026-08-31.

How does Ontogen Manufacturing LLC compare to other Illinois DeviceEstablishmentPulse records?

Its amount of 5 sits in the upper half (87th percentile) of 2,570 records; the median is 1. It is 65 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.

Ontogen Manufacturing LLC vs. top 3 peers

OrganizationLocationAmountPercentileRecord date
Ontogen Manufacturing LLCLisle, IL587th2026-08-31
NGInstruments, Inc dba Avalign Cutting InstrumentsWarsaw, IN483rd2026-10-16
Cook Medical LLCBloomington, IN483rd2026-10-13
Swiss-American CDMO,LLCCarrollton, TX483rd2026-10-12

Related records

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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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