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 Winner Medical Co., Ltd..

707
Total
707
Cleared
187d
Avg days
1978
Since
707 devices
241–264 of 707
Cleared Jul 24, 2013
NEUTROPHASE(R) SKIN AND WOUND CLEANSER OTC
K131542
Novabay Pharmaceuticals, Inc.
General & Plastic Surgery · 56d
Cleared Jul 03, 2013
ABSOCLEAR
K130553
Pharmaplast S.A.E.
General & Plastic Surgery · 121d
Cleared Jul 02, 2013
PROCELLERA
K130350
Vomaris Innovations, Inc.
General & Plastic Surgery · 140d
Cleared Jun 06, 2013
CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSING
K123394
Coreleader Biotech Co., Ltd.
General & Plastic Surgery · 216d
Cleared Jun 06, 2013
AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE
K123481
Convatec, Inc.
General & Plastic Surgery · 205d
Cleared May 01, 2013
HYDROPERMEATE TOPICAL EMULSION, ANSWER2SKIN SUNBURN RELIEF CREAM, ANSWER2SKIN FIRST AID CREAM
K122595
Dermal Life, LLC
General & Plastic Surgery · 250d
Cleared Apr 05, 2013
MEPILEX TRANSFER AG
K123892
Molnlycke Health Care
General & Plastic Surgery · 108d
Cleared Mar 18, 2013
URGOCLEAN ABSORBENT WOUND DRESSING
K123219
Laboratoires Urgo
General & Plastic Surgery · 154d
Cleared Mar 12, 2013
IODOFOAM IODOPHOR FOAM DRESSING
K122634
Progressive Wound Care Technologies, LLC
General & Plastic Surgery · 195d
Cleared Feb 28, 2013
3M TEGADERM CHG CHLORHEXIDINE GLUCONATE I.V. PORT DRESSING
K123679
3M Company
General & Plastic Surgery · 90d
Cleared Feb 14, 2013
LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM
K120181
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 391d
Cleared Feb 14, 2013
VASHE WOUND THERAPY SOLUTION
K123072
Puricore, Inc.
General & Plastic Surgery · 136d
Cleared Jan 24, 2013
VASHE SKIN AND WOUND HYDROGEL
K123071
Puricore, Inc.
General & Plastic Surgery · 115d
Cleared Dec 11, 2012
NIXALL TM WOUND AND SKIN CARE
K113693
Seriously Clean, Ltd.
General & Plastic Surgery · 361d
Cleared Dec 11, 2012
L.A.M. IMP WOUND GEL
K123113
Glycobiosciences, Inc.
General & Plastic Surgery · 69d
Cleared Nov 30, 2012
CURALINE POLYURETHANE FOAM AWC DRESSING
K121361
Curaline, Inc.
General & Plastic Surgery · 207d
Cleared Nov 30, 2012
HYLATOPICPLUS LOTION
K121559
Precision Dermatology Incorporated
General & Plastic Surgery · 185d
Cleared Oct 26, 2012
CHG ANTIBACTERIAL FOAM DRESSING, CHG ANTIBACTERIAL PATCH, CHG ANTIBACTERIAL FOAM PATCH, CHG PATCH, CHG DRESSING
K120930
Medtrade Products , Ltd.
General & Plastic Surgery · 213d
Cleared Sep 24, 2012
BENEHOLD CHG TRANSPARENT FILM DRESSING (10X12CM) (8.5X12CM) (6.5X7 CM)
K113836
Avery Dennison Belgie Bvba
General & Plastic Surgery · 271d
Cleared Sep 06, 2012
LOUTREX TOPICAL CREAM
K120730
Acella Pharmaceuticals, LLC
General & Plastic Surgery · 181d
Cleared Aug 28, 2012
ENLUXTRA HUMIFIBER WOUND DRESSING
K122297
Basf Venture Capital America, Inc.
General & Plastic Surgery · 28d
Cleared Aug 13, 2012
SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER
K121819
Covalontechnologies, Inc.
General & Plastic Surgery · 53d
Cleared Aug 08, 2012
NEUTROPHASE ANTIMICROBIAL WOUND CLEANSER
K113820
Novabay Pharmaceuticals
General & Plastic Surgery · 225d
Cleared Jul 25, 2012
TL TRISEB CREAM
K121134
Trigen Laboratories, Inc.
General & Plastic Surgery · 103d