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
May 04, 1998
DUMEX PAK-ITS-ABSORBASALT COTTON GAUZE PACKING
Dumex Medical Surgical Products, Ltd.
General & Plastic Surgery
63d
Cleared
Mar 05, 1998
20 ML NORMAL SALINE TOPICAL SOLUTION, 0.9% W/V SODIUM CHLORIDE
Steripak, Ltd.
General & Plastic Surgery
268d
Cleared
Feb 13, 1998
ALGOPLAQUE FILM EXTRA THIN HYDROCOLLOID DRESSING
Laboratoires Urgo S.A.
General & Plastic Surgery
86d
Cleared
Dec 23, 1997
DUODERM CONTROL GEL FORMULA BORDER DRESSING
Convatec, Ltd.
General & Plastic Surgery
88d
Cleared
Dec 23, 1997
DUODERM HYDROACTIVE DRESSING
Convatec, Ltd.
General & Plastic Surgery
88d
Cleared
Dec 23, 1997
DUODERM HYDROACTIVE PASTE
Convatec, A Bristol-Myers Squibb Co.
General & Plastic Surgery
78d
Cleared
Dec 22, 1997
DUODERM CGF CONTROL GEL FORMULA DRESSING
Convatec, A Division of E.R. Squibb & Sons
General & Plastic Surgery
89d
Cleared
Dec 17, 1997
DUODERM EXTRA THIN CGF DRESSING
Convatec, A Bristol-Myers Squibb Co.
General & Plastic Surgery
79d
Cleared
Dec 17, 1997
COMBIDERM ACD
Convatec, A Bristol-Myers Squibb Co.
General & Plastic Surgery
79d
Cleared
Dec 16, 1997
KENDALL CURITY PETROLATUM GAUZE
Kendall Healthcare Products Co. Div.Of Tyco Health
General & Plastic Surgery
90d
Cleared
Dec 15, 1997
KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)
Kendall Healthcare Products Co. Div.Of Tyco Health
General & Plastic Surgery
90d
Cleared
Dec 01, 1997
IT HYDROCOLLOID WITH ZINC
Innovative Technologies , Ltd.
General & Plastic Surgery
53d
Cleared
Jul 29, 1997
ARGLAES FILM DRESSING
Maersk Medical, Ltd.
General & Plastic Surgery
166d
Cleared
Jun 24, 1997
HYDROCOLLOID WOUND DRESSINGS
Innovative Technologies , Ltd.
General & Plastic Surgery
89d
Cleared
Feb 07, 1997
MITRAFLEX PIGMENTED WOUND DRESSING
Polymedica Industries, Inc.
General & Plastic Surgery
74d
Cleared
Sep 23, 1996
SURESKIN STANDARD, BORDER, AND THIN
Euromed A/S
General & Plastic Surgery
49d
Cleared
Sep 20, 1996
SIGNALDRESS
Convatec, A Division of E.R. Squibb & Sons
General & Plastic Surgery
80d
Cleared
Nov 29, 1995
TECNOL SALINE WET DRESSING
Tecnol Medical Products, Inc.
General & Plastic Surgery
79d
Cleared
Nov 02, 1995
DERMAGRAN HYDROPHILIC OINTMENT
Derma Sciences, Inc.
General & Plastic Surgery
17d
Cleared
Nov 02, 1995
DERMAGRAN WOUND DRESSING
Derma Sciences, Inc.
General & Plastic Surgery
17d
Cleared
Nov 02, 1995
DERMAGRAN WET DRESSING (ZINC-SALINE)
Derma Sciences, Inc.
General & Plastic Surgery
17d
Cleared
Nov 02, 1995
DERMAGRAN WOUND DRESSING CLEANER W/ZINC
Derma Sciences, Inc.
General & Plastic Surgery
17d
Cleared
Oct 23, 1995
RECLOSABLE WOUND COVER
Hollister, Inc.
General & Plastic Surgery
18d
Cleared
Oct 06, 1995
HOLLISTER HYDROCOLLOID WOUND DRESSING
Hollister, Inc.
General & Plastic Surgery
25d