Traferox Technologies, Inc.: PMA approval for TorEx Lung Perfusion System

Traferox Technologies, Inc. (Mississauga): PMA approval for TorEx Lung Perfusion System. Dated 112 days ago, it serves as a historical benchmark. Score 55/100. As of 2026-11-04, from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration).

Data as of · Compiled by Zalwin from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)

Free preview: all 8 published fields of this record are shown below. Locked: 499 related FdaApprovalPulse records and the 4-column CSV export.

FieldValue
SponsorTraferox Technologies, Inc.
ProductTorEx Lung Perfusion System
Generic / ingredientNormothermic preservation system for transplantation of initially unacceptable donor lungs
ApprovalPMA original approval (new class III device)
ApplicationP250025
Decided2026-07-15
Panel / classGastroenterology, Urology
Sponsor locationMississauga
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  • Source agency: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
  • Record date: 2026-07-15
  • Data refreshed: 2026-11-04
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LIVE PUBLIC DATA Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 06:06:18 GMT

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55 / 100 Score

  • A new product launch.

What is the FdaApprovalPulse record for Traferox Technologies, Inc. in Mississauga?

The FDA approved TorEx Lung Perfusion System (P250025) for Traferox Technologies, Inc. on 2026-07-15: PMA original approval (new class iii device).

How does Traferox Technologies, Inc. compare to other FdaApprovalPulse records?

It is 112 days old; check the official source for later updates before acting.

Traferox Technologies, Inc. vs. top 3 peers

OrganizationLocationRecord date
Traferox Technologies, Inc.Mississauga2026-07-15
Vivasure Medical , Ltd.Galway2026-10-16
Edwards Lifesciences, LLCIrvine, CA2026-10-01
Rejoni, Inc.Bedford, MA2026-09-28

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From openFDA (PMA and Drugs@FDA). openFDA can lag FDA decisions by days to weeks. Drug supplement types follow the FDA submission class (labeling and REMS, manufacturing/CMC, efficacy, other). Company and product level only. Verify on FDA databases before relying on an approval.

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