Home › Device types › NAE
Dressing, Wound, Hydrogel Without Drug And/Or Biologic
FDA product code NAE · Class 1 · General, Plastic Surgery
312
Registered devices
107
Adverse events
6
Recalls
29
510(k) clearances
Devices with this code
DermaGauze — Sion Brands LLCAnscare Hydrocolloid Dressing(Sterile) — BENQ MATERIALS CORP.Mueller Sports Medicine — Mueller Sports Medicine, Inc.Mueller Blister Kit — Mueller Sports Medicine, Inc.Simpurity — SAFE N' SIMPLE LLCSimpurity — SAFE N' SIMPLE LLCLavior — Lavior Pharma Inc.REXALL ADV HEALING HYDROCOLLOID BANDAGES ASSTD. 8CT — Shanghai CareUs Medical Product Co., Ltd.CARE SCIENCE — Aso LLCSimpurity — SAFE N' SIMPLE LLCCVS Health — WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDBurnFree — WATER-JEL TECHNOLOGIES, L.L.C.3M™ Tegaderm™ — 3M COMPANYSimpurity — SAFE N' SIMPLE LLCKerraLite Cool Border — CRAWFORD HEALTHCARE LIMITEDActivHeal — ADVANCED MEDICAL SOLUTIONS LIMITEDMcKesson — MCKESSON MEDICAL-SURGICAL INC.H&H — TRONJEN MEDICAL TECHNOLOGY INC.Cutimed® — BSN medical GmbHAquasite® — Derma Sciences Canada IncAquaDerm — Sion Brands LLCKendall — Cardinal Health 200, LLCGEMCORE360 — ADVANCED MEDICAL SOLUTIONS LIMITEDLavior — Lavior Pharma 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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