FDA Product Code FRO: Dressing, Wound, Drug
FDA product code FRO covers drug-eluting wound dressings that combine a wound contact layer with an active pharmaceutical ingredient.
These dressings deliver antimicrobial agents, growth factors, or analgesics directly to the wound bed while maintaining a moist healing environment. The drug component provides local therapeutic activity beyond the mechanical protection of a standard dressing.
FRO devices are reviewed by the FDA General & Plastic Surgery panel.
Leading manufacturers include Huizhou Foryou Medical Devices Co., Ltd., Convatec, A Division of E.R. Squibb & Sons and Derma Sciences, Inc..
707
Total
707
Cleared
187d
Avg days
1978
Since
707 devices
Cleared
Jan 11, 2024
Copper Foam Dressing (Prescription and OTC)
Roosin Medical Co., Ltd.
General & Plastic Surgery
269d
Cleared
Jan 04, 2024
LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber Cover Dressing
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery
629d
Cleared
Dec 21, 2023
LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery
413d
Cleared
Dec 01, 2023
Antibacterial Gel Wound Dressing
Winner Medical Co., Ltd.
General & Plastic Surgery
232d
Cleared
Nov 17, 2023
Polyver Silver Alginate Dressing (Prescription and OTC)
Roosin Medical Co., Ltd.
General & Plastic Surgery
297d
Cleared
Nov 10, 2023
Skin and Wound Cleanser
Winner Medical Co., Ltd.
General & Plastic Surgery
163d
Cleared
Oct 26, 2023
Antimicrobial Gelling Fiber Dressing with PHMB
Advanced Medical Solutions, Ltd.
General & Plastic Surgery
728d
Cleared
Oct 13, 2023
APIS (R), VERIS (TM)
Sweetbio, Inc.
General & Plastic Surgery
450d
Cleared
Oct 11, 2023
G4Derm / G4Derm Plus Synthetic Wound Matrix
Gel4med, Inc.
General & Plastic Surgery
457d
Cleared
Sep 29, 2023
Antibacterial bandage
Allmed Medical Products Co., Ltd.
General & Plastic Surgery
486d
Cleared
Aug 18, 2023
ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Border Sacrum Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Surgical Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing
Smith & Nephew Medical Limited
General & Plastic Surgery
268d
Cleared
Jun 21, 2023
Antibacterial Bandage
Winner Medical Co., Ltd.
General & Plastic Surgery
412d
Cleared
May 24, 2023
coactiv+™ Antimicrobial Wound Gel
Kane Biotech, Inc.
General & Plastic Surgery
212d
Cleared
Apr 05, 2023
Antimicrobial Silicone PHMB Foam Wound Dressing
Advanced Medical Solutions Limited
General & Plastic Surgery
159d
Cleared
Mar 30, 2023
BIASURGE Advanced Surgical Solution
Rochal Technologies, LLC
General & Plastic Surgery
146d
Cleared
Mar 16, 2023
Sterile Silver Alginate Wound Dressing
Qingdao Bright Moon Biomedical Materials Co., Ltd.
General & Plastic Surgery
374d
Cleared
Jan 30, 2023
PHMB Wound Dressing
Winner Medical Co., Ltd.
General & Plastic Surgery
249d
Cleared
Jan 17, 2023
Ag Foam Dressing Non-Adhesive (OTC)
Winner Medical Co., Ltd.
General & Plastic Surgery
215d
Cleared
Jan 13, 2023
Spectricept Skin and Wound Cleanser
Spectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc.
General & Plastic Surgery
437d
Cleared
Jan 13, 2023
Antimicrobial gauze sponge dressing
Winner Medical Co., Ltd.
General & Plastic Surgery
211d
Cleared
Dec 21, 2022
ELECTROCYN soma
V3Bio Sdn. Bhd
General & Plastic Surgery
323d
Cleared
Dec 21, 2022
Extra Silver Gelling Fiber Dressing
Winner Medical Co., Ltd.
General & Plastic Surgery
191d
Cleared
Oct 26, 2022
Silverlon Wound Contact, Burn Contact Dressings
Argentum Medical, Inc.
General & Plastic Surgery
182d
Cleared
Oct 18, 2022
MEBO Wound Dressing
Mebo Life Science, Inc.
General & Plastic Surgery
46d