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