Gentell, Inc

FDA Regulatory Profile

Summary

Total Recalls
11
510(k) Clearances
1
Inspections
4
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1909-2020Class IIGentell Honey Hydrogel 4"x8" Saturated Gauze- A hydrating wound dressing containing hydrogel and honMarch 26, 2020
Z-1908-2020Class IIGentell Honey Hydrogel 4"x4" Saturated Gauze- A hydrating wound dressing containing hydrogel and honMarch 26, 2020
Z-1910-2020Class IIGentell Honey Hydrogel Hydrogel 4oz. Tube. Wound dressing containing hydrogel and honey (100% LeptoMarch 26, 2020
Z-1907-2020Class IIGentell Honey Hydrogel 2"x2" Saturated Gauze- A hydrating wound dressing containing hydrogel and honMarch 26, 2020
Z-1626-2020Class IIGentell Hydrogel Ag 4oz. Tube, model no. - Product Usage: Under the care of a healthcare professionaFebruary 27, 2020
Z-1624-2020Class IIGentell Hydrogel Ag 4x4, model no. GEN-11420 - Product Usage: Under the care of a healthcare professFebruary 27, 2020
Z-1625-2020Class IIGentell Hydrogel Ag 4x8, model no. GEN-11820 - Product Usage: Under the care of a healthcare professFebruary 27, 2020
Z-1623-2020Class IIGentell Hydrogel Ag 2x2, model no GEN-11220 - Product Usage: Under the care of a healthcare professiFebruary 27, 2020
D-0866-2017Class IIShield and Protect Moisture Barrier Cream, 1.1% Clotrimazole, Net Weight 4 oz - 115 g Anti-Fungal, GApril 19, 2017
D-0243-2017Class IIGentell Hydrogel Wound Dressing REGULAR, 4 oz. tube, Manufactured by: Gentell, 2701 Bristol, PA 1900December 15, 2016
D-0242-2017Class IIGentell Hydrogel Ag Saturated Gauze, 2"x2"(NDC 61551-112-20), 4x4(NDC 61554-114-24) and 4"x8"(NDC 6December 15, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K990440GENTELL HYDROGEL SPRAY GEL, APPLIGARD SQUEEZEAugust 12, 1999