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
Jul 25, 2012
AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBER
Convatec, Inc.
General & Plastic Surgery
89d
Cleared
Jul 09, 2012
OXYBAND WOUND DRESSING
O2s, LLC
General & Plastic Surgery
60d
Cleared
Jun 27, 2012
POLYFIT ABSORBING ANTIMICROBIAL DRESSINGS (OTC)
Polyremedy, Inc.
General & Plastic Surgery
35d
Cleared
May 31, 2012
CELVER
Cellulose Concepts, LLC
General & Plastic Surgery
380d
Cleared
May 23, 2012
MANUKA IG
Links Medical Products, Inc.
General & Plastic Surgery
51d
Cleared
May 23, 2012
MANUKA FILL
Links Medical Products, Inc.
General & Plastic Surgery
30d
Cleared
May 04, 2012
IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER
Covalontechnologies, Inc.
General & Plastic Surgery
246d
Cleared
Apr 20, 2012
SALINE WOUND WASH
Nanoplas, Inc.
General & Plastic Surgery
220d
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
Mar 07, 2012
DEXERYL CREAM
Pierre Fabre Medical Devices
General & Plastic Surgery
75d
Cleared
Feb 09, 2012
HPR EMOLLIENT FOAM
Prugen IP Holdings, Inc.
General & Plastic Surgery
49d
Cleared
Feb 09, 2012
HPR PLUS EMOLLIENT FOAM
Prugen IP Holdings, Inc.
General & Plastic Surgery
49d
Cleared
Dec 15, 2011
EXSALT T7 WOUND DRESSING
Exciton Technologies, Inc.
General & Plastic Surgery
13d
Cleared
Dec 13, 2011
PRECISION SKIN EMULSION
Precision Dermatology Incorporated
General & Plastic Surgery
232d
Cleared
Dec 07, 2011
3M TEGADERM MATRIX DRESSING
3M Company
General & Plastic Surgery
293d
Cleared
Nov 18, 2011
AVO BARRIER TOPICAL EMULSION
Trigen Laboratories, Inc.
General & Plastic Surgery
245d
Cleared
Sep 23, 2011
CORELEADER COLLA-ALGI FIBER MODEL CAW
Coreleader Biotech Co., Ltd.
General & Plastic Surgery
108d
Cleared
Sep 01, 2011
MEDIPLUS-FOAM AG
Medipurpose Pte. , Ltd.
General & Plastic Surgery
234d
Cleared
Aug 19, 2011
SONAFINE WOUND DRESSING
Stratus Pharmaceutical
General & Plastic Surgery
211d
Cleared
Aug 19, 2011
TL-CERMIDE SKIN BARRIER EMULSION
Trigen Laboratories, Inc.
General & Plastic Surgery
154d
Cleared
Jul 27, 2011
MEDIHONEY HYDROGEL SHEET DRESSINGS WITH ACTIVE LEPTOSPERMUM HONEY
Derma Sciences, Inc.
General & Plastic Surgery
152d
Cleared
Jun 16, 2011
ELTA WOUND CLEANSER
Swiss American Products, Inc.
General & Plastic Surgery
177d
Cleared
Jun 03, 2011
EMULSION SB
Prugen IP Holdings, Inc.
General & Plastic Surgery
79d