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
121–144 of 707
Cleared Aug 09, 2018
Titan Ag 200
K173844
Specialty Fibres and Materials, Ltd.
General & Plastic Surgery · 233d
Cleared Aug 07, 2018
Surgical Silver Post Operative Dressing
K180634
Advanced Medical Solutions, Ltd.
General & Plastic Surgery · 148d
Cleared Aug 03, 2018
PHMB Foam Wound Dressing
K181197
Advanced Medical Solutions, Ltd.
General & Plastic Surgery · 88d
Cleared Jul 20, 2018
AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber
K173675
Convatec Limited
General & Plastic Surgery · 232d
Cleared Jul 19, 2018
Medline Burn and Wound Dressing
K173911
Medline Industries, Inc.
General & Plastic Surgery · 209d
Cleared Jul 02, 2018
Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP
K173276
Medline Industries, Inc.
General & Plastic Surgery · 263d
Cleared May 11, 2018
ALGS6 Ag Alginate Wound Dressing
K172570
Foshan United Medical Technologies, Ltd.
General & Plastic Surgery · 256d
Cleared May 01, 2018
LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing
K172554
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 250d
Cleared Apr 27, 2018
HYALURONIC ACID TOPICAL WOUND CREAM
K172747
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)
K180305
Aquilabs Us, LLC
General & Plastic Surgery · 70d
Cleared Apr 04, 2018
Algidex Ag Silver Alginate Wound Dressing
K173072
Deroyal Industries, Inc.
General & Plastic Surgery · 187d
Cleared Apr 02, 2018
Microcyn Antimicrobial Hydrogel
K173896
Sonoma Pharmaceuticals, Inc.
General & Plastic Surgery · 101d
Cleared Feb 21, 2018
Catasyn Advanced Technology Wound Hydrogel
K172338
Synedgen, Inc.
General & Plastic Surgery · 203d
Cleared Dec 01, 2017
Alevicyn SG Antimicrobial Gel
K171935
Sonoma Pharmaceuticals, Inc.
General & Plastic Surgery · 156d
Cleared Nov 21, 2017
3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced Securement Dressing
K170754
3M Company, 3M Healthcare
General & Plastic Surgery · 253d
Cleared Nov 21, 2017
Microcyn Antimicrobial Skin and Wound Cleanser
K172622
Sonoma Pharmaceuticals
General & Plastic Surgery · 81d
Cleared Nov 17, 2017
Endoform Silver Dermal Template
K172318
Aroa Biosurgery
General & Plastic Surgery · 108d
Cleared Nov 15, 2017
Microcyn Plus Antimicrobial Wound Care Solution
K172851
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
K172486
Anexa Biomedical, Inc.
General & Plastic Surgery · 35d
Cleared Aug 25, 2017
Hexagen Derm
K171191
Global Health Solutions, LLC
General & Plastic Surgery · 123d
Cleared Aug 22, 2017
NEOCERA Advanced Barrier Cream
K170911
Exeltis USA Dermatology, LLC
General & Plastic Surgery · 147d
Cleared Aug 22, 2017
SilverSeal
K171041
Alliqua Biomedical, Inc.
General & Plastic Surgery · 137d
Cleared Aug 21, 2017
Sorbact Wound Dressing-Ribbon Gauze
K171225
Abigo Medical AB
General & Plastic Surgery · 117d
Cleared Jul 26, 2017
Hydrocleanse Antimicrobial Skin and Wound Care Solution
K171727
Sonoma Pharmaceuticals
General & Plastic Surgery · 44d