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
289–312 of 707
Cleared May 02, 2011
DURAFIBER AG
K103793
Smith & Nephew, Inc.
General & Plastic Surgery · 126d
Cleared Apr 06, 2011
PRONTOSAN WOUND IRRIGATION SOLUTION
K110744
B.Braun Medical, Inc.
General & Plastic Surgery · 20d
Cleared Apr 01, 2011
HYLATOPICPLUS CREAM
K110727
Precision Dermatology Incorporated
General & Plastic Surgery · 16d
Cleared Mar 24, 2011
MANUKATEX
K110042
Manuka Medical Limited
General & Plastic Surgery · 77d
Cleared Mar 14, 2011
SILVER ANTIMICROBIAL WOUND GEL
K110458
Advanced Medical Solutions Limited
General & Plastic Surgery · 25d
Cleared Feb 22, 2011
MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEY
K101793
Derma Sciences, Inc.
General & Plastic Surgery · 239d
Cleared Dec 10, 2010
PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD
K100261
Tei Biosciences, Inc.
General & Plastic Surgery · 316d
Cleared Nov 03, 2010
PRONTOSAN ANTIMICROBIAL WOUND GEL
K101882
B.Braun Medical, Inc.
General & Plastic Surgery · 120d
Cleared Feb 17, 2010
BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM
K100218
Coloplast A/S
General & Plastic Surgery · 22d
Cleared Jan 07, 2010
MEDLINE CURAD WOUND DRESSINGS
K093349
Medline Industries, Inc.
General & Plastic Surgery · 72d
Cleared Jul 22, 2009
ACTICOAT FLEX 7 DRESSING
K083113
Smith & Nephew, Inc.
General & Plastic Surgery · 274d
Cleared Apr 08, 2009
PROWICK
K083007
Arthrex, Inc.
General & Plastic Surgery · 182d
Cleared Mar 17, 2009
PRONTOSAN ANTIMICROBIAL WOUND GEL
K090141
B.Braun Medical, Inc.
General & Plastic Surgery · 55d
Cleared Jun 19, 2008
PRONTOSAN WOUND IRRIGATION SOLUTION
K072876
B.Braun Medical, Inc.
General & Plastic Surgery · 254d
Cleared Jun 19, 2008
DERMA SCIENCES OTC MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY
K081584
Derma Sciences, Inc.
General & Plastic Surgery · 14d
Cleared Apr 25, 2008
PURACOL PLUS AG COLLAGEN MICROSCAFFOLD WOUND DRESSING
K071552
Medline Industries, Inc.
General & Plastic Surgery · 324d
Cleared Apr 23, 2008
DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY
K080315
Derma Sciences, Inc.
General & Plastic Surgery · 77d
Cleared Nov 09, 2007
PROWICK ANTIMICROBIAL POSTOPERATIVE WOUND DRESSING, SHOULDER AND KNEE, MODELS AR-1625, AR-1626
K072378
Arthrex, Inc.
General & Plastic Surgery · 77d
Cleared Nov 07, 2007
MEDIHONEY PRIMARY DRESSINGS WITH ACTIVE MANUKA HONEY
K072956
Derma Sciences, Inc.
General & Plastic Surgery · 19d
Cleared Aug 03, 2007
ALLEVYN AG DRESSING
K063835
Smith & Nephew, Inc.
General & Plastic Surgery · 220d
Cleared Apr 05, 2007
3M TEGADERM CHG DRESSING
K063458
3M Company
General & Plastic Surgery · 141d
Cleared Mar 19, 2007
SILVERLON DIRECT PRESSURE WOUND CLOSURE STRIP
K984204
Argentum International, LLC
General & Plastic Surgery · 3037d
Cleared Mar 19, 2007
SILVERLON ADHESIVE STRIP
K984205
Argentum International, LLC
General & Plastic Surgery · 3037d
Cleared Oct 11, 2006
SINCLAIR SEBORRHEA EMULSION
K050158
Sinclair Pharmaceuticals, Ltd.
General & Plastic Surgery · 624d