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Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
FDA product code MGQ · Class U · Unknown
137
Registered devices
97
Adverse events
14
Recalls
145
510(k) clearances
Devices with this code
RV-X1 — Gel4med, Inc.DeRoyal — DEROYAL INDUSTRIES, INC.Dash Topic — AIM MEDICAL INC.Medline — MEDLINE INDUSTRIES, INC.Burnshield — BURNSHIELD (PTY) LTDPeriovance — ORABIO, INC.Medline — MEDLINE INDUSTRIES, INC.Ameda, Inc. — AMEDA, INC.Canker-X Rincinol Mouth Sore Rinse — Alliance Pharma Inc.G4Derm Plus — Gel4med, Inc.BURNSHIELD — BURNSHIELD (PTY) LTDAmeda, Inc. — AMEDA, INC.BURNSHIELD — BURNSHIELD (PTY) LTDBioStom — Forward Science Technologies LLCWater-Jel — WATER-JEL TECHNOLOGIES, L.L.C.Burnshield — BURNSHIELD (PTY) LTDDeRoyal — DEROYAL INDUSTRIES, INC.Canker-X Mouth Sore Spray — Alliance Pharma Inc.Burnshield — BURNSHIELD (PTY) LTDSuprello — Gel4med, Inc.DeRoyal — DEROYAL INDUSTRIES, INC.BURNSHIELD — BURNSHIELD (PTY) LTDCanker-X Mouth Sore Gel — Alliance Pharma Inc.Water-Jel — WATER-JEL TECHNOLOGIES, L.L.C.
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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