REVMEDX, INC.

FDA Device Registration & Listing · Wilsonville, OR, US · Registration 3009035955

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009035955
FEI Number
3009035955
Entity Name
REVMEDX, INC.
City/State/Country
Wilsonville, OR, US
Establishment Address
25749 SW CANYON CREEK RD STE 300, Wilsonville, OR 97070, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
RevMedx, Inc. (Owner Number: 10045345)
Owner / Operator Contact Address
25749 SW Canyon Creek Rd Ste 300, Wilsonville, OR 97070, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K180051
PMA Number
N/A

All Registered Proprietary Names

XSTAT P15 XSTAT P30 TX3 TX2 XSTAT 12 XSTAT XGAUZE Trauma Pad XSTAT 30 Generation 2 XSTAT 30 XSTAT 30 Gen2

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PGZ Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use General, Plastic Surgery Class 2 878.4452 2026-06-15
NAB Gauze / Sponge,Nonresorbable For External Use General, Plastic Surgery Class 1 878.4014 2026-06-15
NAB Gauze / Sponge,Nonresorbable For External Use General, Plastic Surgery Class 1 878.4014 2021-09-20
PGZ Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use General, Plastic Surgery Class 2 878.4452 2021-09-20
GAX Tourniquet, Nonpneumatic General, Plastic Surgery Class 1 878.5900 2015-02-24
PGZ Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use General, Plastic Surgery Class 2 878.4452 2017-05-15
NAB Gauze / Sponge,Nonresorbable For External Use General, Plastic Surgery Class 1 878.4014 2015-01-21
NAB Gauze / Sponge,Nonresorbable For External Use General, Plastic Surgery Class 1 878.4014 2018-07-17
PGZ Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use General, Plastic Surgery Class 2 878.4452 2018-07-17

Official Correspondent

Amy Pointer

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

RevMedx, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009035955. Last updated year: 2026. Please use registration number 3009035955 when referencing this establishment in official correspondence.
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