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 Convatec, A Division of E.R. Squibb & Sons, Winner Medical Co., Ltd. and Huizhou Foryou Medical Devices Co., Ltd..
705
Total
705
Cleared
187d
Avg days
1978
Since
705 devices
Cleared
Mar 26, 1986
ACTISORB ACTIVATED CHARCOAL DRESSING
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery
44d
Cleared
Nov 15, 1985
DUODERM HYDROACTIVE DRESSING W/BORDER STERILE
Convatec, A Division of E.R. Squibb & Sons
General & Plastic Surgery
60d
Cleared
Sep 19, 1985
TEGADERM PLUS TRANSPARENT DRESSING #952X
3M Company
General & Plastic Surgery
84d
Cleared
Sep 05, 1985
BAND-AID BRAND ADHESIVE BANDAGES
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery
83d
Cleared
Jul 05, 1985
CUTINOVA GELFILM SYNTHETIC WOUND DRESSING, STERILE
Beiersdorf, Inc.
General & Plastic Surgery
172d
Cleared
Jul 05, 1985
BARD OCCLUSIVE WOUND DRESSING
C.R. Bard, Inc.
General & Plastic Surgery
123d
Cleared
Jun 05, 1985
J & J ULCER DRESSING
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery
119d
Cleared
Nov 08, 1984
AQUAPHOR R GAUZE
Beiersdorf, Inc.
General & Plastic Surgery
104d
Cleared
Nov 07, 1984
COMFEEL ULCUS SHEET
Coloplast A/S
General & Plastic Surgery
280d
Cleared
Aug 20, 1984
DUODERM FLEXIBLE HYDROACTIVE DRESSINGS
Convatec, A Division of E.R. Squibb & Sons
General & Plastic Surgery
145d
Cleared
Jan 19, 1984
DECUBITUS CARE ABSORBENT DRESSING
American Pharmaseal Div. Ahsc
General & Plastic Surgery
182d
Cleared
Jan 03, 1984
BARD ABSORPTION DRESSING
C.R. Bard, Inc.
General & Plastic Surgery
221d
Cleared
May 05, 1983
DUO DERM FLEX HYDROACTIVE DRESSINGS &
Convatec, A Division of E.R. Squibb & Sons
General & Plastic Surgery
59d
Cleared
Apr 12, 1983
CONVERTORS PRIMARY WOUND DRESSING II
American Hospital Supply Corp.
General & Plastic Surgery
182d
Cleared
Dec 17, 1982
CURITY TRANSPARENT FILM DRESSING
The Kendal Co.
General & Plastic Surgery
127d
Cleared
Oct 13, 1982
DUODERM HYDROACTIVE GRANULES
Convatec, A Division of E.R. Squibb & Sons
General & Plastic Surgery
131d
Cleared
Sep 07, 1982
DUODERM FLEXIBLE HYDROACTIVE DRESSINGS
Convatec, A Division of E.R. Squibb & Sons
General & Plastic Surgery
95d
Cleared
Aug 31, 1982
PVP GEL DRESSING
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery
176d
Cleared
Jan 25, 1982
TEGADERM TRANSPARENT DRESSING
3M Company
General & Plastic Surgery
125d
Cleared
Mar 28, 1978
I.V. START KIT
Marion Laboratories, Inc.
General & Plastic Surgery
47d