Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Gri-Alleset, Inc.

FDA 510(k) & PMA Approved Devices — 4 products

Total Devices4
Categories3
Latest FDA decision2024-11-05
TypeNumberDevice NameCodeDateActions
510(k) K242664 gentleheel® Adult Incision DeviceFMK2024-11-05 View
510(k) K220917 gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel ToddlerFMK2022-05-18 View
510(k) K210860 Comfort Guard Mask, level 1, Comfort Guard Mask, level 3FXX2022-04-07 View
510(k) K210131 ComfortGuard Surgical Isolation GownFYC2021-08-26 View