Data / Medical devices / United States / Revmedx, Inc.

Revmedx, Inc.: FDA-registered device maker in Wilsonville, OR, United States, 4 510(k) clearances

Name: Revmedx, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Revmedx, Inc. is registered with the FDA (registration 3009035955) in Wilsonville, OR, United States. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated November 12, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Revmedx, Inc.

FDA registration number: 3009035955
Address: 25749 SW Canyon Creek RD Ste 300, Wilsonville, OR, United States, 97070
Owner or operator: RevMedx, Inc. (10045345)
Roles: Manufacturer, Specification developer
First device listed: November 7, 2013
Registered through: 2026
Brand names listed: AirWrap, AirWrap XL, TX2, TX3, XGAUZE Trauma Pad, XSTAT, XSTAT 12, XSTAT 30, XSTAT 30 Gen2 and more

Devices it lists

Device	Product code	Class	Role	Source
Dressing, Compression	MHW	1	Manufacturer, Specification developer	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Manufacturer, Specification developer	accessdata.fda.gov
Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use	PGZ	2	Manufacturer	accessdata.fda.gov
Tourniquet, Nonpneumatic	GAX	1	Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 12, 2025	K253290	XSTAT P15	PGZ	Substantially Equivalent	Revmedx, Inc.	accessdata.fda.gov
August 27, 2021	K210676	XSTAT 30 Pouch	PGZ	Substantially Equivalent	Revmedx, Inc.	accessdata.fda.gov
May 18, 2018	K180051	XSTAT 30, 1-Pack	PGZ	Substantially Equivalent	Revmedx, Inc.	accessdata.fda.gov
May 1, 2017	K170334	XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack	PGZ	Substantially Equivalent	Revmedx, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
August 12, 2015	72019	Class II	Terminated	XGAUZE Trauma Dressing, catalog number FIN-0002-01. XGAUZE is a 3" x 36" z-folded rayon/polyester dressing embedded with individual compressed cellulose sponges. Upon contact with blood or exudate, the sponges expand, th	The XGAUZE Trauma Dressing was recalled because the packages may acquire small tears or pinholes during shipping due to use of shipping containers that lacked adequate protective materials. If present, these small tears or pinholes may disrupt package integrity and render the device unsterile.	accessdata.fda.gov

Compare with other makers

Updated November 12, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.