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
265–288 of 707
Cleared Jul 25, 2012
AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBER
K121275
Convatec, Inc.
General & Plastic Surgery · 89d
Cleared Jul 09, 2012
OXYBAND WOUND DRESSING
K121407
O2s, LLC
General & Plastic Surgery · 60d
Cleared Jun 27, 2012
POLYFIT ABSORBING ANTIMICROBIAL DRESSINGS (OTC)
K121522
Polyremedy, Inc.
General & Plastic Surgery · 35d
Cleared May 31, 2012
CELVER
K111382
Cellulose Concepts, LLC
General & Plastic Surgery · 380d
Cleared May 23, 2012
MANUKA IG
K120976
Links Medical Products, Inc.
General & Plastic Surgery · 51d
Cleared May 23, 2012
MANUKA FILL
K121227
Links Medical Products, Inc.
General & Plastic Surgery · 30d
Cleared May 04, 2012
IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER
K112549
Covalontechnologies, Inc.
General & Plastic Surgery · 246d
Cleared Apr 20, 2012
SALINE WOUND WASH
K112666
Nanoplas, Inc.
General & Plastic Surgery · 220d
Cleared Apr 12, 2012
CURAD ANTIBACTERIAL BANDAGE
K113583
Medline Industries, Inc.
General & Plastic Surgery · 129d
Cleared Apr 05, 2012
BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X4 INCHES, & 5X5 INCHES
K120828
Coloplast A/S
General & Plastic Surgery · 17d
Cleared Mar 07, 2012
DEXERYL CREAM
K113807
Pierre Fabre Medical Devices
General & Plastic Surgery · 75d
Cleared Feb 09, 2012
HPR EMOLLIENT FOAM
K113772
Prugen IP Holdings, Inc.
General & Plastic Surgery · 49d
Cleared Feb 09, 2012
HPR PLUS EMOLLIENT FOAM
K113774
Prugen IP Holdings, Inc.
General & Plastic Surgery · 49d
Cleared Dec 15, 2011
EXSALT T7 WOUND DRESSING
K113564
Exciton Technologies, Inc.
General & Plastic Surgery · 13d
Cleared Dec 13, 2011
PRECISION SKIN EMULSION
K111168
Precision Dermatology Incorporated
General & Plastic Surgery · 232d
Cleared Dec 07, 2011
3M TEGADERM MATRIX DRESSING
K110457
3M Company
General & Plastic Surgery · 293d
Cleared Nov 18, 2011
AVO BARRIER TOPICAL EMULSION
K110762
Trigen Laboratories, Inc.
General & Plastic Surgery · 245d
Cleared Sep 23, 2011
CORELEADER COLLA-ALGI FIBER MODEL CAW
K111578
Coreleader Biotech Co., Ltd.
General & Plastic Surgery · 108d
Cleared Sep 01, 2011
MEDIPLUS-FOAM AG
K110062
Medipurpose Pte. , Ltd.
General & Plastic Surgery · 234d
Cleared Aug 19, 2011
SONAFINE WOUND DRESSING
K110172
Stratus Pharmaceutical
General & Plastic Surgery · 211d
Cleared Aug 19, 2011
TL-CERMIDE SKIN BARRIER EMULSION
K110757
Trigen Laboratories, Inc.
General & Plastic Surgery · 154d
Cleared Jul 27, 2011
MEDIHONEY HYDROGEL SHEET DRESSINGS WITH ACTIVE LEPTOSPERMUM HONEY
K110546
Derma Sciences, Inc.
General & Plastic Surgery · 152d
Cleared Jun 16, 2011
ELTA WOUND CLEANSER
K103713
Swiss American Products, Inc.
General & Plastic Surgery · 177d
Cleared Jun 03, 2011
EMULSION SB
K110732
Prugen IP Holdings, Inc.
General & Plastic Surgery · 79d