Home › Device types › NAE
Dressing, Wound, Hydrogel Without Drug And/Or Biologic
FDA product code NAE · Class 1 · General, Plastic Surgery
304
Registered devices
105
Adverse events
6
Recalls
29
510(k) clearances
Devices with this code
BurnFree — WATER-JEL TECHNOLOGIES, L.L.C.Discount Drug Mart Food Fair — DISCOUNT DRUG MART, INC.DynaSafety XeroBurn Sterile Burn Dressing, 8" x 18" — Dynarex CorporationWound Seal Kit — H&H MEDICAL CORPORATIONSion Biotext Medical Ltd. — SION BIOTEXT MEDICAL LTDLeukomed® — BSN medical GmbHExchange Select — AafesMedline — MEDLINE INDUSTRIES, INC.Curaplex — BOUND TREE MEDICAL, LLCUp&Up — TARGET CORPORATIONEMSRUN — Wuxi Emsrun Technology Co., Ltd.XeroBurn Sterile Burn Dressings, 4" x 4" — Dynarex CorporationComfort Tape — Orthonu LLCBurnFree — WATER-JEL TECHNOLOGIES, L.L.C.DUODERM PASTE AND GELS — CONVATEC, PURCHASING DEPARTMENTProCure — Twin Med, LLCNAR — NORTH AMERICAN RESCUE, LLCvaginal virgin gel/tightening gel cream — Jiaoyue Pharmaceuticals (Huizhou) Co., Ltd.3M™ Nu-Gel™ — 3M Deutschland GmbH3M™ Kerralite Cool™ — 3M Deutschland GmbHBurnFree — WATER-JEL TECHNOLOGIES, L.L.C.GEMCORE360 — ADVANCED MEDICAL SOLUTIONS LIMITEDSolventum™ Nu-Gel™ — Solventum Germany GmbHZeni Medical — Focus Health Group, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-02-11 | Nelson Innovaions, Llc | Foreign material near or along the edge of the hydrogel adhesive within the pouch packaging |
| 2018-08-22 | Safe N Simple, LLC | The sterilization process used was unqualified. |
| 2018-08-22 | Safe N Simple, LLC | The sterilization process used was unqualified. |
| 2016-09-01 | CellEra LLC | Adhesive border was not sticky enough. |
| 2015-09-30 | O-Two Medical Technologies, Inc. | For lack of evidence to validate effectiveness of sterilization dose, O-Two Medical Technologies Inc. hereby announces a voluntary medical device recall of the |
| 2006-11-09 | Embeem Inc. | Foreign material- this device, a sterile wound care product, was found to be contaminated with clumps of brown/black foreign material |
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