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 Convatec, A Division of E.R. Squibb & Sons, Winner Medical Co., Ltd. and Huizhou Foryou Medical Devices Co., Ltd..
705
Total
705
Cleared
187d
Avg days
1978
Since
705 devices
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
Cleared
Aug 19, 2022
Bonvadis Topical Cream
Stemcyte, Inc.
General & Plastic Surgery
371d
Cleared
Apr 22, 2022
LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery
372d
Cleared
Mar 23, 2022
LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery
378d
Cleared
Feb 24, 2022
PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing
3M Healthcare Business Group
General & Plastic Surgery
401d
Cleared
Jan 14, 2022
Silver Gelling Fiber Dressing
Winner Medical Co., Ltd.
General & Plastic Surgery
332d