Gentell, Inc
FDA Regulatory Profile
Gentell, Inc appears in FDA public data with 11 recalls, 1 510(k) clearance, 4 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1909-2020, Class II) was initiated on March 26, 2020. Its most recent 510(k) clearance was granted on August 12, 1999.
Summary
- Total Recalls
- 11
- 510(k) Clearances
- 1
- Inspections
- 4
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1909-2020 | Class II | Gentell Honey Hydrogel 4"x8" Saturated Gauze- A hydrating wound dressing containing hydrogel and hon | March 26, 2020 |
| Z-1908-2020 | Class II | Gentell Honey Hydrogel 4"x4" Saturated Gauze- A hydrating wound dressing containing hydrogel and hon | March 26, 2020 |
| Z-1910-2020 | Class II | Gentell Honey Hydrogel Hydrogel 4oz. Tube. Wound dressing containing hydrogel and honey (100% Lepto | March 26, 2020 |
| Z-1907-2020 | Class II | Gentell Honey Hydrogel 2"x2" Saturated Gauze- A hydrating wound dressing containing hydrogel and hon | March 26, 2020 |
| Z-1626-2020 | Class II | Gentell Hydrogel Ag 4oz. Tube, model no. - Product Usage: Under the care of a healthcare professiona | February 27, 2020 |
| Z-1624-2020 | Class II | Gentell Hydrogel Ag 4x4, model no. GEN-11420 - Product Usage: Under the care of a healthcare profess | February 27, 2020 |
| Z-1623-2020 | Class II | Gentell Hydrogel Ag 2x2, model no GEN-11220 - Product Usage: Under the care of a healthcare professi | February 27, 2020 |
| Z-1625-2020 | Class II | Gentell Hydrogel Ag 4x8, model no. GEN-11820 - Product Usage: Under the care of a healthcare profess | February 27, 2020 |
| D-0866-2017 | Class II | Shield and Protect Moisture Barrier Cream, 1.1% Clotrimazole, Net Weight 4 oz - 115 g Anti-Fungal, G | April 19, 2017 |
| D-0242-2017 | Class II | Gentell Hydrogel Ag Saturated Gauze, 2"x2"(NDC 61551-112-20), 4x4(NDC 61554-114-24) and 4"x8"(NDC 6 | December 15, 2016 |
| D-0243-2017 | Class II | Gentell Hydrogel Wound Dressing REGULAR, 4 oz. tube, Manufactured by: Gentell, 2701 Bristol, PA 1900 | December 15, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K990440 | GENTELL HYDROGEL SPRAY GEL, APPLIGARD SQUEEZE | August 12, 1999 |