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
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
May 23, 2017
Prontosan Wound Gel
B.Braun Medical, Inc.
General & Plastic Surgery
167d
Cleared
Nov 10, 2016
Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL
B.Braun Medical, Inc.
General & Plastic Surgery
150d
Cleared
Oct 08, 2013
PRONTOSAN WOUND GEL X
B.Braun Medical, Inc.
General & Plastic Surgery
194d
Cleared
Feb 28, 2013
3M TEGADERM CHG CHLORHEXIDINE GLUCONATE I.V. PORT DRESSING
3M Company
General & Plastic Surgery
90d
Cleared
Apr 12, 2012
CURAD ANTIBACTERIAL BANDAGE
Medline Industries, Inc.
General & Plastic Surgery
129d
Cleared
Apr 05, 2012
BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X4 INCHES, & 5X5 INCHES
Coloplast A/S
General & Plastic Surgery
17d
Cleared
Dec 07, 2011
3M TEGADERM MATRIX DRESSING
3M Company
General & Plastic Surgery
293d
Cleared
May 02, 2011
DURAFIBER AG
Smith & Nephew, Inc.
General & Plastic Surgery
126d
Cleared
Apr 06, 2011
PRONTOSAN WOUND IRRIGATION SOLUTION
B.Braun Medical, Inc.
General & Plastic Surgery
20d
Cleared
Nov 03, 2010
PRONTOSAN ANTIMICROBIAL WOUND GEL
B.Braun Medical, Inc.
General & Plastic Surgery
120d
Cleared
Feb 17, 2010
BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM
Coloplast A/S
General & Plastic Surgery
22d
Cleared
Jan 07, 2010
MEDLINE CURAD WOUND DRESSINGS
Medline Industries, Inc.
General & Plastic Surgery
72d
Cleared
Jul 22, 2009
ACTICOAT FLEX 7 DRESSING
Smith & Nephew, Inc.
General & Plastic Surgery
274d
Cleared
Apr 08, 2009
PROWICK
Arthrex, Inc.
General & Plastic Surgery
182d
Cleared
Mar 17, 2009
PRONTOSAN ANTIMICROBIAL WOUND GEL
B.Braun Medical, Inc.
General & Plastic Surgery
55d
Cleared
Jun 19, 2008
PRONTOSAN WOUND IRRIGATION SOLUTION
B.Braun Medical, Inc.
General & Plastic Surgery
254d