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 02, 2006
AGCEL WOUND DRESSING,AGCEL BURN DRESSING
Modern Medical Equipment Mfg., Ltd.
General & Plastic Surgery
488d
Cleared
May 17, 2006
EUROMED SURESKIN III WITH SILVER WOUND DRESSINGS
Euromed, Inc.
General & Plastic Surgery
495d
Cleared
Mar 17, 2006
TRIOSYN T40 ANTIMICROBIAL WOUND DRESSING
Triosyn Corp.
General & Plastic Surgery
280d
Cleared
Feb 17, 2006
BRENNEN MEDICAL SILVER GLUCAN WOUND DRESSING
Brennen Medical, Inc.
General & Plastic Surgery
400d
Cleared
Feb 03, 2006
SUCRALFATE AND CARAFATE PASTE KITS
Patrick D. Mcgrath Ph.D
General & Plastic Surgery
402d
Cleared
Dec 16, 2005
3M TEGADERM SILVER (AG) MESH
3M Company
General & Plastic Surgery
24d
Cleared
Dec 05, 2005
SILVERSEAL SILVERAID WITH X-STATIC
Noble Fiber Technologies, Inc.
General & Plastic Surgery
262d
Cleared
Nov 08, 2005
FORTADERM ANTIMICROBIAL WOUND DRESSING
Organogenesis, Inc.
General & Plastic Surgery
140d
Cleared
Oct 20, 2005
MEDLINE IODOFORM PACKING STRIPS
Medline Industries, Inc.
General & Plastic Surgery
21d
Cleared
Oct 17, 2005
BIODERM SCIENCES WOUND CREAM
Bioderm Sciences, Inc.
General & Plastic Surgery
413d
Cleared
Aug 22, 2005
MILLIKEN SILVER WOUND DRESSINGS
Milliken Chemical
General & Plastic Surgery
81d
Cleared
Jun 15, 2005
BIODERM SCIENCES WOUND HEALING SPRAY
Bioderm Sciences, Inc.
General & Plastic Surgery
316d
Cleared
Jun 13, 2005
SILVERSEAL CONTACTING WOUND DRESSING WITH X-STATIC
Noble Fiber Technologies, Inc.
General & Plastic Surgery
91d
Cleared
Jun 09, 2005
SILVER ANTIMICROBIAL WOUND GAUZE (SPONGE)
Medline Industries, Inc.
General & Plastic Surgery
302d
Cleared
Jun 06, 2005
COLACTIVE AG COLLAGEN WITH SILVER ANTIMICROBIAL DRESSING
Covalontechnologies, Inc.
General & Plastic Surgery
189d
Cleared
May 17, 2005
EPI-MAX
Dermagenics, Inc.
General & Plastic Surgery
389d
Cleared
May 17, 2005
DERMACYN WOUND IRRIGATION
Oculus Innovative Sciences, Inc.
General & Plastic Surgery
228d
Cleared
May 03, 2005
MICROCYN WOUND CARE DRESSING
Oculus Innovative Sciences, Inc.
General & Plastic Surgery
365d
Cleared
Apr 21, 2005
ACTICOAT MOISTURE CONTROL DRESSING
Smith & Nephew, Inc.
General & Plastic Surgery
104d
Cleared
Dec 01, 2004
MEDTRADE PRODUCTS ANTISEPTIC BARRIER SILVER FOAM DRESSING, MODEL 09912450
Medtrade Products , Ltd.
General & Plastic Surgery
369d
Cleared
Nov 02, 2004
3M TEGADERM SILVER
3M Company
General & Plastic Surgery
223d
Cleared
Aug 05, 2004
ANTIMICROBIAL ALGINATE DRESSING
Advanced Medical Solutions, Ltd.
General & Plastic Surgery
80d
Cleared
May 17, 2004
CONTREET FOAM CAVITY DRESSING WITH SILVER, MODEL 9628 (2X4 IN.)
Coloplast Corp.
General & Plastic Surgery
157d
Cleared
Oct 22, 2003
FERRIS POLYMEM SILVER WOUND DRESSING
Ferris Mfg. Corp.
General & Plastic Surgery
181d