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 30, 1985
ATRAUM WOUND DRESSING
Axiom Medical, Inc.
General & Plastic Surgery
71d
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
Apr 27, 1984
HYDRON WOUND DRESSING FAST SEAT KIT
National Patent Development Corp.
General & Plastic Surgery
261d
Cleared
Apr 23, 1984
STERILE ABSORBENT GAUZE BURN & SOUND
Chesebrough-Pond'S U.S.A. Co.
General & Plastic Surgery
61d
Cleared
Jan 27, 1984
NON ADHERENT BANDAGE/SHEET
American Medical Disposable, Inc.
General & Plastic Surgery
94d
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
Dec 27, 1983
NON - ADHERENT BANDAGE
American Medical Disposable, Inc.
General & Plastic Surgery
63d
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 30, 1982
PERFILM MEMBRANE DRESSING
Chesebrough-Pond'S U.S.A. Co.
General & Plastic Surgery
136d
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
Jan 06, 1981
DRESSING CHANGE FOR G TUBE
American Medical Disposable, Inc.
General & Plastic Surgery
27d
Cleared
Dec 22, 1980
HYPERALIMENTATION DRESSING CHANGE TRAY
American Medical Disposable, Inc.
General & Plastic Surgery
12d
Cleared
Dec 17, 1980
ZINC PASTE BANDAGE
Secol Co.
General & Plastic Surgery
43d