Revmedx Inc

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
7
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2762-2015Class IIXGAUZE Trauma Dressing, catalog number FIN-0002-01. XGAUZE is a 3" x 36" z-folded rayon/polyesterAugust 12, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K253290XSTAT P15November 12, 2025
K210676XSTAT 30 PouchAugust 27, 2021
K180051XSTAT 30, 1-PackMay 18, 2018
K170334XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 PackMay 1, 2017
K161020XSTAT-12, 3-Pack, XSTAT-12, 1-PackJuly 28, 2016
K152624XSTAT 30, 3-PACK, XSTAT 30, 1-PACKDecember 7, 2015
DEN130016XSTATApril 3, 2014