FRO

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
409–432 of 707
Cleared Apr 01, 1988
TEGASORB ULCER DRESSING #90-XXX
K872298
3M Company
General & Plastic Surgery · 291d
Cleared Mar 23, 1988
FERRIS HYDROPHILIC DRESSING
K880330
Ferris Mfg. Corp.
General & Plastic Surgery · 56d
Cleared Mar 21, 1988
AIRSTRIP* WATERPROOF FIRST AID DRESS/POST-OPERA.
K881048
Smith & Nephew, Inc.
General & Plastic Surgery · 10d
Cleared Feb 22, 1988
DERMATOLOGICAL PATCH
K872926
Convatec, A Division of E.R. Squibb & Sons
General & Plastic Surgery · 210d
Cleared Nov 17, 1987
COMFEEL ULCUS ULCER CARE SYSTEM
K873669
Coloplast A/S
General & Plastic Surgery · 67d
Cleared Aug 06, 1987
FERRIS TRANSPARENT WOUND DRESSING W/HYDROCOLLOID
K871675
Ferris Mfg. Corp.
General & Plastic Surgery · 100d
Cleared Jul 29, 1987
INTRASITE INTERACTIVE HYDROCOLLOID WOUND DRESSING
K872624
Smith & Nephew, Inc.
General & Plastic Surgery · 23d
Cleared Jul 24, 1987
CUTINOVA(R) PLUS FOAM GELFILM
K864913
Beiersdorf, Inc.
General & Plastic Surgery · 220d
Cleared Jun 26, 1987
AMERICAN PHARMASEAL WOUND DRESSING
K871770
American Pharmaseal Div. Ahsc
General & Plastic Surgery · 51d
Cleared Feb 06, 1987
BANDAGE, GAUZE, FINE MESH, 3 BY 8 INCHES
K870184
Fraass Survival Systems, Inc.
General & Plastic Surgery · 21d
Cleared Feb 06, 1987
COMPRESS AND BANDAGE, VARIOUS SIZES
K870241
Fraass Survival Systems, Inc.
General & Plastic Surgery · 16d
Cleared Feb 04, 1987
FERRIS DYNADERM PLUS
K865089
Ferris Mfg. Corp.
General & Plastic Surgery · 36d
Cleared Dec 01, 1986
VISCOPASTE ZINC PASTE BANDAGE
K863930
Smith & Nephew, Inc.
General & Plastic Surgery · 54d
Cleared Nov 21, 1986
LYOFOAM C ODOR-ABSORBING DRESSING
K864084
Acme United Corp.
General & Plastic Surgery · 32d
Cleared Nov 14, 1986
CHESEBROUGH POND'S HYDROCOLLOID DRESSING
K862803
Chesebrough-Pond'S U.S.A. Co.
General & Plastic Surgery · 115d
Cleared Sep 30, 1986
HYDROCOLLOID DRESSINGS - STERILE
K863390
Convatec, A Division of E.R. Squibb & Sons
General & Plastic Surgery · 27d
Cleared Aug 04, 1986
HOLLISTER WOUND CARE BARRIER
K862572
Hollister, Inc.
General & Plastic Surgery · 28d
Cleared Jul 09, 1986
JOHNSON & JOHNSON PETROLATUM GAUZE NON ADHER DRESS
K862163
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 33d
Cleared Jul 01, 1986
NON-ADHERING DRESSING WITH POVIDONE-IODINE
K861384
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 78d
Cleared Apr 10, 1986
BARD ABSORPTION DRESSING
K861024
C.R. Bard, Inc.
General & Plastic Surgery · 23d
Cleared Mar 26, 1986
ACTISORB ACTIVATED CHARCOAL DRESSING
K860486
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 44d
Cleared Nov 15, 1985
DUODERM HYDROACTIVE DRESSING W/BORDER STERILE
K853844
Convatec, A Division of E.R. Squibb & Sons
General & Plastic Surgery · 60d
Cleared Sep 19, 1985
TEGADERM PLUS TRANSPARENT DRESSING #952X
K852750
3M Company
General & Plastic Surgery · 84d
Cleared Sep 05, 1985
BAND-AID BRAND ADHESIVE BANDAGES
K852545
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 83d