Home › Device types › MGQ
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
FDA product code MGQ · Class U · Unknown
141
Registered devices
97
Adverse events
14
Recalls
145
510(k) clearances
Devices with this code
Water-Jel — WATER-JEL TECHNOLOGIES, L.L.C.RV-X1 — Gel4med, Inc.GlucanPro 3000 — STELLEN MEDICAL, LLCBURNSHIELD — BURNSHIELD (PTY) LTDPuraGel 5mL — 3-D MATRIX INC.FASTRACT — BENCO DENTAL SUPPLY CO.Periovance — ORABIO, INC.Burnshield — BURNSHIELD (PTY) LTDCARDINAL HEALTH — Cardinal Health 200, LLCBurnshield — BURNSHIELD (PTY) LTDBurnFree — WATER-JEL TECHNOLOGIES, L.L.C.Promiseb Topical Cream — Primus Pharmaceuticals, Inc.Dash Topic — AIM MEDICAL INC.DeRoyal — DEROYAL INDUSTRIES, INC.Hyalo4 Care Clear Hydrogel, 30g — FIDIA FARMACEUTICI SPABURNSHIELD — BURNSHIELD (PTY) LTDWater-Jel — WATER-JEL TECHNOLOGIES, L.L.C.BenaCel — UNICARE BIOMEDICAL INC.Water-Jel — WATER-JEL TECHNOLOGIES, L.L.C.Burn Stop — WATER-JEL TECHNOLOGIES, L.L.C.BURNSHIELD — BURNSHIELD (PTY) LTDBurnshield — BURNSHIELD (PTY) LTDBenaCel — UNICARE BIOMEDICAL INC.Medline — MEDLINE INDUSTRIES, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-03-03 | Covidien LLC | Product sterility is compromised due to breach of sterile barrier |
| 2015-03-26 | PhotoMedex, Inc. | The labeling for the Iamin family of medical devices (e.g. printed and internet text) is not consistent with the intended uses and limitations identified at the |
| 2015-02-25 | Amerx Health Care Corp. | Nonapproved labeling claims (Sterile) |
| 2014-09-26 | Amerx Health Care Corp. | Formulation deviation |
| 2014-09-26 | Amerx Health Care Corp. | Formulation deviation |
| 2014-09-26 | Amerx Health Care Corp. | Formulation deviation |
| 2014-09-26 | Amerx Health Care Corp. | Formulation deviation |
| 2014-07-11 | Amerx Health Care Corp. | Not approved labeling claims (antimicrobial and autolytic debridement) |
| 2014-07-11 | Amerx Health Care Corp. | Not approved labeling claims (antimicrobial and autolytic debridement) |
| 2014-07-11 | Amerx Health Care Corp. | Not approved labeling claims (antimicrobial and autolytic debridement) |
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