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
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
Cleared
Oct 19, 2021
Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use)
Winner Medical Co., Ltd.
General & Plastic Surgery
384d
Cleared
Sep 23, 2021
TorrentX Wound Wash
Next Science, LLC
General & Plastic Surgery
304d
Cleared
Sep 01, 2021
Omeza Collagen Matrix
Omeza, LLC
General & Plastic Surgery
69d
Cleared
May 12, 2021
High Performance Antimicrobial Gelling Fiber with Silver
Advanced Medical Solutions, Ltd.
General & Plastic Surgery
41d
Cleared
Apr 23, 2021
MIS Solution
Next Science, LLC
General & Plastic Surgery
114d
Cleared
Apr 14, 2021
AMSure® Single Use Saline Topical Solution
Amsino Medical, Inc.
General & Plastic Surgery
351d
Cleared
Feb 05, 2021
Antibacterial Bandage
Jiangsu Excellence Medical Supplies Co., Ltd.
General & Plastic Surgery
263d
Cleared
Jan 28, 2021
LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC use)
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery
286d
Cleared
Oct 19, 2020
anti-bacterial bandage
Planet (Suzhou) Medical Products Co., Ltd.
General & Plastic Surgery
203d
Cleared
Oct 08, 2020
SilverStream Gel
Enzysurge , Ltd.
General & Plastic Surgery
197d
Cleared
Sep 04, 2020
MEBO Wound Dressing
Mebo Life Science, Inc.
General & Plastic Surgery
268d
Cleared
Sep 04, 2020
3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad
3M Company
General & Plastic Surgery
157d
Cleared
Sep 03, 2020
HaloGUARD Protective Disc with CHG
Attwill Medical Solutions
General & Plastic Surgery
176d
Cleared
Jun 17, 2020
LT Antibacterial Alginate with Silver Dressing
Zhejiang Longterm Medical Technology Co., Ltd.
General & Plastic Surgery
281d
Cleared
May 14, 2020
Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border
Winner Medical Co., Ltd.
General & Plastic Surgery
314d
Cleared
May 14, 2020
PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing with Border
Winner Medical Co., Ltd.
General & Plastic Surgery
248d
Cleared
May 11, 2020
PuraDERM Gel
3-D Matrix, Inc.
General & Plastic Surgery
188d
Cleared
Mar 11, 2020
AC5 Topical Gel
Arch Therapeutics, Inc.
General & Plastic Surgery
408d
Cleared
Feb 21, 2020
Biatain Silicone Ag
Coloplast A/S
General & Plastic Surgery
256d