Gri-Alleset, Inc. FDA Approvals

0 new drug approvals and 4 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
gentleheel® Adult Incision Device510(k)Nov 5, 2024General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Nov 5, 2024
gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler510(k)May 18, 2022General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	May 18, 2022
Comfort Guard Mask, level 1, Comfort Guard Mask, level 3510(k)Apr 7, 2022General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Apr 7, 2022
ComfortGuard Surgical Isolation Gown510(k)Aug 26, 2021General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Aug 26, 2021