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 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
Cleared
Aug 09, 2018
Titan Ag 200
Specialty Fibres and Materials, Ltd.
General & Plastic Surgery
233d
Cleared
Aug 07, 2018
Surgical Silver Post Operative Dressing
Advanced Medical Solutions, Ltd.
General & Plastic Surgery
148d
Cleared
Aug 03, 2018
PHMB Foam Wound Dressing
Advanced Medical Solutions, Ltd.
General & Plastic Surgery
88d
Cleared
Jul 20, 2018
AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber
Convatec Limited
General & Plastic Surgery
232d
Cleared
Jul 19, 2018
Medline Burn and Wound Dressing
Medline Industries, Inc.
General & Plastic Surgery
209d