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
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
Apr 01, 2011
HYLATOPICPLUS CREAM
Precision Dermatology Incorporated
General & Plastic Surgery
16d
Cleared
Mar 24, 2011
MANUKATEX
Manuka Medical Limited
General & Plastic Surgery
77d
Cleared
Mar 14, 2011
SILVER ANTIMICROBIAL WOUND GEL
Advanced Medical Solutions Limited
General & Plastic Surgery
25d
Cleared
Feb 22, 2011
MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEY
Derma Sciences, Inc.
General & Plastic Surgery
239d
Cleared
Dec 10, 2010
PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD
Tei Biosciences, Inc.
General & Plastic Surgery
316d
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
Cleared
Jun 19, 2008
DERMA SCIENCES OTC MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY
Derma Sciences, Inc.
General & Plastic Surgery
14d
Cleared
Apr 25, 2008
PURACOL PLUS AG COLLAGEN MICROSCAFFOLD WOUND DRESSING
Medline Industries, Inc.
General & Plastic Surgery
324d
Cleared
Apr 23, 2008
DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY
Derma Sciences, Inc.
General & Plastic Surgery
77d
Cleared
Nov 09, 2007
PROWICK ANTIMICROBIAL POSTOPERATIVE WOUND DRESSING, SHOULDER AND KNEE, MODELS AR-1625, AR-1626
Arthrex, Inc.
General & Plastic Surgery
77d
Cleared
Nov 07, 2007
MEDIHONEY PRIMARY DRESSINGS WITH ACTIVE MANUKA HONEY
Derma Sciences, Inc.
General & Plastic Surgery
19d
Cleared
Aug 03, 2007
ALLEVYN AG DRESSING
Smith & Nephew, Inc.
General & Plastic Surgery
220d
Cleared
Apr 05, 2007
3M TEGADERM CHG DRESSING
3M Company
General & Plastic Surgery
141d
Cleared
Mar 19, 2007
SILVERLON DIRECT PRESSURE WOUND CLOSURE STRIP
Argentum International, LLC
General & Plastic Surgery
3037d
Cleared
Mar 19, 2007
SILVERLON ADHESIVE STRIP
Argentum International, LLC
General & Plastic Surgery
3037d
Cleared
Oct 11, 2006
SINCLAIR SEBORRHEA EMULSION
Sinclair Pharmaceuticals, Ltd.
General & Plastic Surgery
624d