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
Apr 01, 1988
TEGASORB ULCER DRESSING #90-XXX
3M Company
General & Plastic Surgery
291d
Cleared
Mar 23, 1988
FERRIS HYDROPHILIC DRESSING
Ferris Mfg. Corp.
General & Plastic Surgery
56d
Cleared
Mar 21, 1988
AIRSTRIP* WATERPROOF FIRST AID DRESS/POST-OPERA.
Smith & Nephew, Inc.
General & Plastic Surgery
10d
Cleared
Feb 22, 1988
DERMATOLOGICAL PATCH
Convatec, A Division of E.R. Squibb & Sons
General & Plastic Surgery
210d
Cleared
Nov 17, 1987
COMFEEL ULCUS ULCER CARE SYSTEM
Coloplast A/S
General & Plastic Surgery
67d
Cleared
Aug 06, 1987
FERRIS TRANSPARENT WOUND DRESSING W/HYDROCOLLOID
Ferris Mfg. Corp.
General & Plastic Surgery
100d
Cleared
Jul 29, 1987
INTRASITE INTERACTIVE HYDROCOLLOID WOUND DRESSING
Smith & Nephew, Inc.
General & Plastic Surgery
23d
Cleared
Jul 24, 1987
CUTINOVA(R) PLUS FOAM GELFILM
Beiersdorf, Inc.
General & Plastic Surgery
220d
Cleared
Jun 26, 1987
AMERICAN PHARMASEAL WOUND DRESSING
American Pharmaseal Div. Ahsc
General & Plastic Surgery
51d
Cleared
Feb 06, 1987
BANDAGE, GAUZE, FINE MESH, 3 BY 8 INCHES
Fraass Survival Systems, Inc.
General & Plastic Surgery
21d
Cleared
Feb 06, 1987
COMPRESS AND BANDAGE, VARIOUS SIZES
Fraass Survival Systems, Inc.
General & Plastic Surgery
16d
Cleared
Feb 04, 1987
FERRIS DYNADERM PLUS
Ferris Mfg. Corp.
General & Plastic Surgery
36d
Cleared
Dec 01, 1986
VISCOPASTE ZINC PASTE BANDAGE
Smith & Nephew, Inc.
General & Plastic Surgery
54d
Cleared
Nov 21, 1986
LYOFOAM C ODOR-ABSORBING DRESSING
Acme United Corp.
General & Plastic Surgery
32d
Cleared
Nov 14, 1986
CHESEBROUGH POND'S HYDROCOLLOID DRESSING
Chesebrough-Pond'S U.S.A. Co.
General & Plastic Surgery
115d
Cleared
Sep 30, 1986
HYDROCOLLOID DRESSINGS - STERILE
Convatec, A Division of E.R. Squibb & Sons
General & Plastic Surgery
27d
Cleared
Aug 04, 1986
HOLLISTER WOUND CARE BARRIER
Hollister, Inc.
General & Plastic Surgery
28d
Cleared
Jul 09, 1986
JOHNSON & JOHNSON PETROLATUM GAUZE NON ADHER DRESS
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery
33d
Cleared
Jul 01, 1986
NON-ADHERING DRESSING WITH POVIDONE-IODINE
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery
78d
Cleared
Apr 10, 1986
BARD ABSORPTION DRESSING
C.R. Bard, Inc.
General & Plastic Surgery
23d
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