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 16, 1995
SALINE DRESSING
Busse Hospital Disposables, Inc.
General & Plastic Surgery
51d
Cleared
Jul 11, 1995
HOLLISTER HYDROCOLLOID WOUND DRESSINGS
Hollister, Inc.
General & Plastic Surgery
132d
Cleared
Feb 07, 1995
PREPPIES SKIN BARRIER WIPE
Kendall Healthcare Products Co. Div.Of Tyco Health
General & Plastic Surgery
81d
Cleared
Dec 10, 1993
SPYROFILM IQ WOUND DRESSING(WITH INERT FILLER)
Polymedica Industries, Inc.
General & Plastic Surgery
191d
Cleared
Nov 24, 1993
SALINE WET DRESSING- STERILE
Trinity Laboratories, Inc.
General & Plastic Surgery
85d
Cleared
May 27, 1993
DERMAGRAN WOUND DRESSING
Derma Sciences, Inc.
General & Plastic Surgery
246d
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
Jun 06, 1990
WOUND TREATMENT KIT
Orion Life Systems, Inc.
General & Plastic Surgery
89d
Cleared
Jan 03, 1990
SILASTIC SOFT SHEETING
Dow Corning Wright
General & Plastic Surgery
198d
Cleared
Aug 23, 1989
KALTOCARB WOUND DRESSING
Calgon Vestal Div.
General & Plastic Surgery
40d
Cleared
Aug 09, 1989
INTRASITE* GEL (3) YEAR SHELF LIFE
Smith & Nephew United, Inc.
General & Plastic Surgery
152d
Cleared
Jul 14, 1989
KALTOSTAT WOUND PACKING
Calgon Vestal Div.
General & Plastic Surgery
86d
Cleared
Jun 23, 1989
KALTOSTAT(TM) WOUND DRESSING
Calgon Vestal Div.
General & Plastic Surgery
78d
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
Jun 05, 1989
WATER JEL STERILE GEL-SOAKED BURN DRESSING
Pfizer, Inc.
General & Plastic Surgery
60d
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
Oct 05, 1988
SKINCOTE
Dynarex Corp.
General & Plastic Surgery
105d
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