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
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
Cleared
Oct 11, 2019
Protego Antimicrobial Wound Dressing
Global Health Solutions (Dba Turn Therapeutics)
General & Plastic Surgery
287d
Cleared
Sep 20, 2019
Clyra Wound Irrigation Solution
Clyra Medical Technologies, Inc.
General & Plastic Surgery
476d
Cleared
Sep 13, 2019
Roosin Xeroform Petrolatum Dressing
Roosin Medical Co., Ltd.
General & Plastic Surgery
465d
Cleared
Sep 12, 2019
Saline Wound Wash, SteriCleanse(TM)
Ascent Consumer Products, Inc.
General & Plastic Surgery
259d
Cleared
Aug 15, 2019
Suprasorb A + Ag “R”
Speciality Fibres and Materials, Ltd.
General & Plastic Surgery
269d
Cleared
Jul 25, 2019
Silicone PHMB Foam Wound Dressing
Advanced Medical Solutions, Ltd.
General & Plastic Surgery
115d
Cleared
Jul 18, 2019
Silverlon Wound Contact, Burn Contact Dressings
Argentum Medical, LLC
General & Plastic Surgery
154d
Cleared
May 31, 2019
Apis
Sweetbio, Inc.
General & Plastic Surgery
245d
Cleared
May 29, 2019
Silver High Performance Dressing
Advanced Medical Solutions, Ltd.
General & Plastic Surgery
154d
Cleared
Mar 08, 2019
Medline Burn and Wound Dressing (OTC)
Medline Industries, Inc.
General & Plastic Surgery
31d
Cleared
Feb 14, 2019
Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing
Winner Medical Co., Ltd.
General & Plastic Surgery
272d
Cleared
Jan 14, 2019
Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing)
Argentum Medical, LLC
General & Plastic Surgery
315d
Cleared
Dec 14, 2018
AC5 Topical Gel
Arch Therapeutics, Inc.
General & Plastic Surgery
79d
Cleared
Dec 10, 2018
Procellera Composite Antibacterial Wound Dressing
Vomaris Wound Care, Inc.
General & Plastic Surgery
285d
Cleared
Dec 06, 2018
KerraContact Ag Perf Advanced Perforated Silver Wound Dressing
Exciton Technologies, Inc.
General & Plastic Surgery
71d
Cleared
Nov 23, 2018
MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs)
Medcu Technologies , Ltd.
General & Plastic Surgery
256d
Cleared
Sep 07, 2018
AMSure Sterile Water, and Sterile Normal Saline for Wound Flush
Amsino International, Inc.
General & Plastic Surgery
99d
Cleared
Aug 17, 2018
Simple Science Antimicrobial Facial and Eyelid Cleanser
Simple Science, LLC
General & Plastic Surgery
115d
Cleared
Aug 13, 2018
BIAFINE
Valeant Pharmaceuticals
General & Plastic Surgery
270d