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
433–456 of 707
Cleared Aug 30, 1985
ATRAUM WOUND DRESSING
K852614
Axiom Medical, Inc.
General & Plastic Surgery · 71d
Cleared Jul 05, 1985
CUTINOVA GELFILM SYNTHETIC WOUND DRESSING, STERILE
K850147
Beiersdorf, Inc.
General & Plastic Surgery · 172d
Cleared Jul 05, 1985
BARD OCCLUSIVE WOUND DRESSING
K850889
C.R. Bard, Inc.
General & Plastic Surgery · 123d
Cleared Jun 05, 1985
J & J ULCER DRESSING
K850451
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 119d
Cleared Nov 08, 1984
AQUAPHOR R GAUZE
K842967
Beiersdorf, Inc.
General & Plastic Surgery · 104d
Cleared Nov 07, 1984
COMFEEL ULCUS SHEET
K840438
Coloplast A/S
General & Plastic Surgery · 280d
Cleared Aug 20, 1984
DUODERM FLEXIBLE HYDROACTIVE DRESSINGS
K841287
Convatec, A Division of E.R. Squibb & Sons
General & Plastic Surgery · 145d
Cleared Apr 27, 1984
HYDRON WOUND DRESSING FAST SEAT KIT
K832699
National Patent Development Corp.
General & Plastic Surgery · 261d
Cleared Apr 23, 1984
STERILE ABSORBENT GAUZE BURN & SOUND
K840745
Chesebrough-Pond'S U.S.A. Co.
General & Plastic Surgery · 61d
Cleared Jan 27, 1984
NON ADHERENT BANDAGE/SHEET
K833730
American Medical Disposable, Inc.
General & Plastic Surgery · 94d
Cleared Jan 19, 1984
DECUBITUS CARE ABSORBENT DRESSING
K832407
American Pharmaseal Div. Ahsc
General & Plastic Surgery · 182d
Cleared Jan 03, 1984
BARD ABSORPTION DRESSING
K831710
C.R. Bard, Inc.
General & Plastic Surgery · 221d
Cleared Dec 27, 1983
NON - ADHERENT BANDAGE
K833733
American Medical Disposable, Inc.
General & Plastic Surgery · 63d
Cleared May 05, 1983
DUO DERM FLEX HYDROACTIVE DRESSINGS &
K830708
Convatec, A Division of E.R. Squibb & Sons
General & Plastic Surgery · 59d
Cleared Apr 12, 1983
CONVERTORS PRIMARY WOUND DRESSING II
K822990
American Hospital Supply Corp.
General & Plastic Surgery · 182d
Cleared Dec 30, 1982
PERFILM MEMBRANE DRESSING
K822467
Chesebrough-Pond'S U.S.A. Co.
General & Plastic Surgery · 136d
Cleared Dec 17, 1982
CURITY TRANSPARENT FILM DRESSING
K822424
The Kendal Co.
General & Plastic Surgery · 127d
Cleared Oct 13, 1982
DUODERM HYDROACTIVE GRANULES
K821655
Convatec, A Division of E.R. Squibb & Sons
General & Plastic Surgery · 131d
Cleared Sep 07, 1982
DUODERM FLEXIBLE HYDROACTIVE DRESSINGS
K821656
Convatec, A Division of E.R. Squibb & Sons
General & Plastic Surgery · 95d
Cleared Aug 31, 1982
PVP GEL DRESSING
K820635
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 176d
Cleared Jan 25, 1982
TEGADERM TRANSPARENT DRESSING
K812678
3M Company
General & Plastic Surgery · 125d
Cleared Jan 06, 1981
DRESSING CHANGE FOR G TUBE
K803115
American Medical Disposable, Inc.
General & Plastic Surgery · 27d
Cleared Dec 22, 1980
HYPERALIMENTATION DRESSING CHANGE TRAY
K803114
American Medical Disposable, Inc.
General & Plastic Surgery · 12d
Cleared Dec 17, 1980
ZINC PASTE BANDAGE
K802791
Secol Co.
General & Plastic Surgery · 43d