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
Feb 03, 2003
CONTREET FOAM ADHESIVE/NON-ADHESIVE
Coloplast Corp.
General & Plastic Surgery
194d
Cleared
Oct 17, 2002
DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414
Dynarex Corp.
General & Plastic Surgery
421d
Cleared
Jun 21, 2002
ABSORBENT ANTIMICROBIAL WOUND DRESSING
Convatec, A Division of E.R. Squibb & Sons
General & Plastic Surgery
217d
Cleared
Jun 07, 2000
ACTICOAT PRIMARY ANTIMICROBIAL DRESSING
Westaim Biomedical, Inc.
General & Plastic Surgery
342d
Cleared
Apr 17, 2000
ACRYDERM SILVER ANTI-MICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044, 1045
Acrymed, Inc.
General & Plastic Surgery
326d
Cleared
Dec 30, 1999
SALJET SINGLE DOSE STERILE SALINE TOPICAL SOLUTION
Winchester Laboratories, LLC
General & Plastic Surgery
37d
Cleared
Nov 05, 1999
ANTIBACTERIAL ADHESIVE BANDAGE
William Feinstein & Associates, Inc.
General & Plastic Surgery
77d
Cleared
Sep 24, 1999
SILVERLON WOUND PACKING STRIPS
Argentum International, LLC
General & Plastic Surgery
304d
Cleared
Sep 17, 1999
ARGLAES-AB ANTIMICROBIAL BARRIER FILM DRESSING & ISLAND DRESSING
Maersk Medical, Ltd.
General & Plastic Surgery
190d
Cleared
Aug 12, 1999
SURESKIN II STANDARD, SURESKIN II BORDER, SURESKIN II THIN
Euromed, Inc.
General & Plastic Surgery
28d
Cleared
Jun 29, 1999
SPYROGEL HYDROGEL WOUND AND BURN DRESSING SA
Advanced Medical Solutions Group Plc
General & Plastic Surgery
76d
Cleared
May 27, 1999
DERMAPHYLYX HYDROCOLLOID WOUND DRESSING, HEALIAN HYDROCOLLOID WOUND DRESSING
Dermaphylyx, Inc.
General & Plastic Surgery
71d
Cleared
Apr 14, 1999
DUMEX IODOFORM PACKING STRIP
Dumex Medical Surgical Products, Ltd.
General & Plastic Surgery
70d
Cleared
Mar 19, 1999
SILON DUAL-DRESS
Bio Med Sciences, Inc.
General & Plastic Surgery
72d
Cleared
Mar 01, 1999
MODIFICATION OF CUTINOVA THIN DRESSING
Beiersdorf-Jobt, Inc.
General & Plastic Surgery
63d
Cleared
Mar 01, 1999
MODIFICATION OF CUTINOVA HYDRO DRESSING
Beiersdorf-Jobt, Inc.
General & Plastic Surgery
63d
Cleared
Mar 01, 1999
MODIFICATION OF CUTINOVA CAVITY DRESSING
Beiersdorf-Jobt, Inc.
General & Plastic Surgery
63d
Cleared
Mar 01, 1999
MODIFICATION OF CUTINOVA FOAM DRESSING
Beiersdorf-Jobt, Inc.
General & Plastic Surgery
63d
Cleared
Feb 22, 1999
SILVERLON ISLAND DRESSING, SILVERLON ISLAND PAD
Argentum International, LLC
General & Plastic Surgery
90d
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
Nov 25, 1998
SURESKIN PLUS STANDARD, SURESKIN PLUS BORDER, SURESKIN PLUS THIN
Euromed, Inc.
General & Plastic Surgery
70d
Cleared
Sep 25, 1998
SILVERLON CONTACT WOUND DRESSING
Argentum International, LLC
General & Plastic Surgery
169d