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
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
Cleared
Feb 07, 2020
Rochal Antimicrobial Wound Gel
Rochal Industries, LLC
General & Plastic Surgery
147d
Cleared
Dec 20, 2019
IODOSORB
Smith & Nephew Medical, Ltd.
General & Plastic Surgery
274d
Cleared
Dec 20, 2019
IODOFLEX
Smith & Nephew Medical, Ltd.
General & Plastic Surgery
270d
Cleared
Nov 06, 2019
Hydrofera Blue READY - Border
Hydrofera, LLC
General & Plastic Surgery
271d
Cleared
Oct 18, 2019
BIAFINE Topical Cream
Bausch Health Americas Incorporated
General & Plastic Surgery
246d