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
Sep 25, 1991
INCARE HOT/ICE ABSORBENT INTERFACE
Hollister, Inc.
General & Plastic Surgery
78d
Cleared
Jan 25, 1991
DUODERM DRESSINGS, CGF DRESSINGS, PASTE FULL THICK
Convatec, A Division of E.R. Squibb & Sons
General & Plastic Surgery
88d
Cleared
Jan 03, 1990
SILASTIC SOFT SHEETING
Dow Corning Wright
General & Plastic Surgery
198d
Cleared
Jun 13, 1989
CUTINOVA(R) PLUS ON VASCULAR STASIS ULCERS
Beiersdorf, Inc.
General & Plastic Surgery
172d
Cleared
Jun 09, 1989
TEGASORB(TM) ULCER DRESSING, #90-XXX
3M Company
General & Plastic Surgery
91d
Cleared
May 05, 1989
ACTIDERM*-OPAQUE
Convatec, A Division of E.R. Squibb & Sons
General & Plastic Surgery
31d
Cleared
Mar 03, 1989
PHARMACLENS LOW ABRASION WOUND SPONGE/BRUSH
Baxter Healthcare Corp
General & Plastic Surgery
88d
Cleared
Dec 27, 1988
PHARMASEAL STERILE WOUND CARE DRESSING
Baxter Healthcare Corp
General & Plastic Surgery
69d
Cleared
Sep 22, 1988
COMPEED ATHLETIC DRESSING
Coloplast A/S
General & Plastic Surgery
31d
Cleared
Jun 22, 1988
HYDROCOLLOID DRESSING FOR PSORIASIS
Hollister, Inc.
General & Plastic Surgery
103d
Cleared
Apr 28, 1988
DUODERM(R) HYDROACTIVE(R) PASTE
Convatec, A Division of E.R. Squibb & Sons
General & Plastic Surgery
31d
Cleared
Apr 01, 1988
TEGASORB ULCER DRESSING #90-XXX
3M Company
General & Plastic Surgery
291d
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
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
Dec 01, 1986
VISCOPASTE ZINC PASTE BANDAGE
Smith & Nephew, Inc.
General & Plastic Surgery
54d
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