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
Apr 25, 2008
PURACOL PLUS AG COLLAGEN MICROSCAFFOLD WOUND DRESSING
Medline Industries, Inc.
General & Plastic Surgery
324d
Cleared
Nov 09, 2007
PROWICK ANTIMICROBIAL POSTOPERATIVE WOUND DRESSING, SHOULDER AND KNEE, MODELS AR-1625, AR-1626
Arthrex, Inc.
General & Plastic Surgery
77d
Cleared
Aug 03, 2007
ALLEVYN AG DRESSING
Smith & Nephew, Inc.
General & Plastic Surgery
220d
Cleared
Apr 05, 2007
3M TEGADERM CHG DRESSING
3M Company
General & Plastic Surgery
141d
Cleared
Dec 16, 2005
3M TEGADERM SILVER (AG) MESH
3M Company
General & Plastic Surgery
24d
Cleared
Oct 20, 2005
MEDLINE IODOFORM PACKING STRIPS
Medline Industries, Inc.
General & Plastic Surgery
21d
Cleared
Jun 09, 2005
SILVER ANTIMICROBIAL WOUND GAUZE (SPONGE)
Medline Industries, Inc.
General & Plastic Surgery
302d
Cleared
Apr 21, 2005
ACTICOAT MOISTURE CONTROL DRESSING
Smith & Nephew, Inc.
General & Plastic Surgery
104d
Cleared
Nov 02, 2004
3M TEGADERM SILVER
3M Company
General & Plastic Surgery
223d
Cleared
May 17, 2004
CONTREET FOAM CAVITY DRESSING WITH SILVER, MODEL 9628 (2X4 IN.)
Coloplast Corp.
General & Plastic Surgery
157d
Cleared
Feb 03, 2003
CONTREET FOAM ADHESIVE/NON-ADHESIVE
Coloplast Corp.
General & Plastic Surgery
194d
Cleared
Jun 21, 2002
ABSORBENT ANTIMICROBIAL WOUND DRESSING
Convatec, A Division of E.R. Squibb & Sons
General & Plastic Surgery
217d
Cleared
Jan 28, 1999
COMPEED PSORIASIS DRESSING
Coloplast Corp.
General & Plastic Surgery
195d
Cleared
Dec 16, 1998
BIATAIN FOAM DRESSING
Coloplast Corp.
General & Plastic Surgery
97d
Cleared
Dec 16, 1998
BIATAIN FOAM ADHESIVE DRESSING
Coloplast Corp.
General & Plastic Surgery
97d
Cleared
Dec 22, 1997
DUODERM CGF CONTROL GEL FORMULA DRESSING
Convatec, A Division of E.R. Squibb & Sons
General & Plastic Surgery
89d
Cleared
Dec 16, 1997
KENDALL CURITY PETROLATUM GAUZE
Kendall Healthcare Products Co. Div.Of Tyco Health
General & Plastic Surgery
90d
Cleared
Dec 15, 1997
KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)
Kendall Healthcare Products Co. Div.Of Tyco Health
General & Plastic Surgery
90d
Cleared
Sep 20, 1996
SIGNALDRESS
Convatec, A Division of E.R. Squibb & Sons
General & Plastic Surgery
80d
Cleared
Oct 23, 1995
RECLOSABLE WOUND COVER
Hollister, Inc.
General & Plastic Surgery
18d
Cleared
Oct 06, 1995
HOLLISTER HYDROCOLLOID WOUND DRESSING
Hollister, Inc.
General & Plastic Surgery
25d
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
Nov 24, 1993
SALINE WET DRESSING- STERILE
Trinity Laboratories, Inc.
General & Plastic Surgery
85d