FRO

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
73–96 of 707
Cleared Aug 19, 2022
Bonvadis Topical Cream
K212554
Stemcyte, Inc.
General & Plastic Surgery · 371d
Cleared Apr 22, 2022
LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel
K211123
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
K210718
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 378d
Cleared Feb 24, 2022
PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing
K210135
3M Healthcare Business Group
General & Plastic Surgery · 401d
Cleared Jan 14, 2022
Silver Gelling Fiber Dressing
K210466
Winner Medical Co., Ltd.
General & Plastic Surgery · 332d
Cleared Oct 19, 2021
Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use)
K202982
Winner Medical Co., Ltd.
General & Plastic Surgery · 384d
Cleared Sep 23, 2021
TorrentX Wound Wash
K203446
Next Science, LLC
General & Plastic Surgery · 304d
Cleared Sep 01, 2021
Omeza Collagen Matrix
K211972
Omeza, LLC
General & Plastic Surgery · 69d
Cleared May 12, 2021
High Performance Antimicrobial Gelling Fiber with Silver
K210974
Advanced Medical Solutions, Ltd.
General & Plastic Surgery · 41d
Cleared Apr 23, 2021
MIS Solution
K203835
Next Science, LLC
General & Plastic Surgery · 114d
Cleared Apr 14, 2021
AMSure® Single Use Saline Topical Solution
K201138
Amsino Medical, Inc.
General & Plastic Surgery · 351d
Cleared Feb 05, 2021
Antibacterial Bandage
K201324
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)
K201016
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 286d
Cleared Oct 19, 2020
anti-bacterial bandage
K200821
Planet (Suzhou) Medical Products Co., Ltd.
General & Plastic Surgery · 203d
Cleared Oct 08, 2020
SilverStream Gel
K200767
Enzysurge , Ltd.
General & Plastic Surgery · 197d
Cleared Sep 04, 2020
MEBO Wound Dressing
K193439
Mebo Life Science, Inc.
General & Plastic Surgery · 268d
Cleared Sep 04, 2020
3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad
K200835
3M Company
General & Plastic Surgery · 157d
Cleared Sep 03, 2020
HaloGUARD Protective Disc with CHG
K200641
Attwill Medical Solutions
General & Plastic Surgery · 176d
Cleared Jun 17, 2020
LT Antibacterial Alginate with Silver Dressing
K192478
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
K191819
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
K192463
Winner Medical Co., Ltd.
General & Plastic Surgery · 248d
Cleared May 11, 2020
PuraDERM Gel
K193085
3-D Matrix, Inc.
General & Plastic Surgery · 188d
Cleared Mar 11, 2020
AC5 Topical Gel
K190129
Arch Therapeutics, Inc.
General & Plastic Surgery · 408d
Cleared Feb 21, 2020
Biatain Silicone Ag
K191536
Coloplast A/S
General & Plastic Surgery · 256d