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
Aug 28, 2014
SILVERLON ISLAND WOUND DRESSING
Argentum Medical
General & Plastic Surgery
77d
Cleared
Aug 21, 2014
IONSIL GEL
Virchow Biotech Pvt, Ltd.
General & Plastic Surgery
391d
Cleared
Aug 08, 2014
HYDROCLEANSE WOUND CARE SOLUTION
Oculus Innovative Sciences
General & Plastic Surgery
109d
Cleared
Jun 19, 2014
HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER
The Hymed Group Corp.
General & Plastic Surgery
276d
Cleared
May 20, 2014
ASAP OTC WOUND DRESSING GEL
Abl Medical, LLC
General & Plastic Surgery
83d
Cleared
May 12, 2014
ROSS RU SKIN DISCONTINUITIES
Biotd S.A.
General & Plastic Surgery
382d
Cleared
May 02, 2014
MANUKA FOAM HC, MANUKA FOAM HC (WITH ACRYLIC ADHESIVE BORDER), MANUKA FOAM HC (WITH SILICONE ADHESIVE BORDER)
Links Medical Products, Inc.
General & Plastic Surgery
130d
Cleared
May 01, 2014
SILVERLON ISLAND WOUND DRESSING
Argentum Medical, LLC
General & Plastic Surgery
594d
Cleared
Apr 28, 2014
PURACYN PLUS SKIN AND WOUND
Innovacyn, Inc.
General & Plastic Surgery
161d
Cleared
Apr 22, 2014
BCT ANTIMICROBIAL DRESSING & BCT SILVER BANDAGE
Bio-Medical Carbon Technology Co., Ltd.
General & Plastic Surgery
90d
Cleared
Mar 31, 2014
VASHE WOUND SOLUTION (4.0 OZ), (8.5 OZ & (16.0 OZ)
Puricore, Inc.
General & Plastic Surgery
283d
Cleared
Mar 26, 2014
EXSALT SD7 WOUND DRESSING WITH ADHESIVE BACKING
Exciton Technologies, Inc.
General & Plastic Surgery
104d
Cleared
Mar 14, 2014
MANUKA FILL WOUND DRESSING
Links Medical Products, Inc.
General & Plastic Surgery
269d
Cleared
Mar 13, 2014
CHLORASHIELD IV DRESSING WITH CHG ANTIMICROBIAL
Avery Dennison Belgie Bvba
General & Plastic Surgery
92d
Cleared
Mar 03, 2014
IPM WOUND GEL BIO
Glycobiosciences, Inc.
General & Plastic Surgery
508d
Cleared
Feb 14, 2014
L.A.M. IPM WOUND GEL, IPM DERM GEL
Glycobiosciences, Inc.
General & Plastic Surgery
330d
Cleared
Feb 12, 2014
MEPITEL AG
Molnlycke Health Care
General & Plastic Surgery
401d
Cleared
Jan 02, 2014
HYDROFERA BLUE PU BACTERIOSTATIC DRESSING
Hydrofera, LLC
General & Plastic Surgery
296d
Cleared
Dec 20, 2013
NIVATOPIC PLUS
Nivagen Pharmaceuticals, Inc.
General & Plastic Surgery
147d
Cleared
Dec 16, 2013
HYALMIX CREAM
Igi Laboratories, Inc.
General & Plastic Surgery
381d
Cleared
Oct 29, 2013
WOUNDWASH SALINE SPRAY
Neilmed Pharmaceuticals, Inc.
General & Plastic Surgery
314d
Cleared
Oct 08, 2013
PRONTOSAN WOUND GEL X
B.Braun Medical, Inc.
General & Plastic Surgery
194d
Cleared
Aug 28, 2013
DERMISEB CREAM
Igi Laboratories, Inc.
General & Plastic Surgery
267d
Cleared
Aug 07, 2013
PROTHELIAL
Mueller Medical International, LLC
General & Plastic Surgery
231d