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 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
Cleared
Jul 02, 2018
Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP
Medline Industries, Inc.
General & Plastic Surgery
263d
Cleared
May 11, 2018
ALGS6 Ag Alginate Wound Dressing
Foshan United Medical Technologies, Ltd.
General & Plastic Surgery
256d
Cleared
May 01, 2018
LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery
250d
Cleared
Apr 27, 2018
HYALURONIC ACID TOPICAL WOUND CREAM
Virchow Biotech Pvt, Ltd.
General & Plastic Surgery
227d
Cleared
Apr 13, 2018
Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC)
Aquilabs Us, LLC
General & Plastic Surgery
70d
Cleared
Apr 04, 2018
Algidex Ag Silver Alginate Wound Dressing
Deroyal Industries, Inc.
General & Plastic Surgery
187d
Cleared
Apr 02, 2018
Microcyn Antimicrobial Hydrogel
Sonoma Pharmaceuticals, Inc.
General & Plastic Surgery
101d
Cleared
Feb 21, 2018
Catasyn Advanced Technology Wound Hydrogel
Synedgen, Inc.
General & Plastic Surgery
203d
Cleared
Dec 01, 2017
Alevicyn SG Antimicrobial Gel
Sonoma Pharmaceuticals, Inc.
General & Plastic Surgery
156d
Cleared
Nov 21, 2017
3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced Securement Dressing
3M Company, 3M Healthcare
General & Plastic Surgery
253d
Cleared
Nov 21, 2017
Microcyn Antimicrobial Skin and Wound Cleanser
Sonoma Pharmaceuticals
General & Plastic Surgery
81d
Cleared
Nov 17, 2017
Endoform Silver Dermal Template
Aroa Biosurgery
General & Plastic Surgery
108d
Cleared
Nov 15, 2017
Microcyn Plus Antimicrobial Wound Care Solution
Sonoma Pharmaceuticals, Inc.
General & Plastic Surgery
56d
Cleared
Sep 21, 2017
Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 120 mL cup, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 100mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 250mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 500mL bottle
Anexa Biomedical, Inc.
General & Plastic Surgery
35d
Cleared
Aug 25, 2017
Hexagen Derm
Global Health Solutions, LLC
General & Plastic Surgery
123d
Cleared
Aug 22, 2017
NEOCERA Advanced Barrier Cream
Exeltis USA Dermatology, LLC
General & Plastic Surgery
147d
Cleared
Aug 22, 2017
SilverSeal
Alliqua Biomedical, Inc.
General & Plastic Surgery
137d
Cleared
Aug 21, 2017
Sorbact Wound Dressing-Ribbon Gauze
Abigo Medical AB
General & Plastic Surgery
117d
Cleared
Jul 26, 2017
Hydrocleanse Antimicrobial Skin and Wound Care Solution
Sonoma Pharmaceuticals
General & Plastic Surgery
44d