Gri-Alleset, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
4
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K242664gentleheel® Adult Incision DeviceNovember 5, 2024
K220917gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel ToddlerMay 18, 2022
K210860Comfort Guard Mask, level 1, Comfort Guard Mask, level 3April 7, 2022
K210131ComfortGuard Surgical Isolation GownAugust 26, 2021