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
337–360 of 707
Cleared Feb 03, 2003
CONTREET FOAM ADHESIVE/NON-ADHESIVE
K022416
Coloplast Corp.
General & Plastic Surgery · 194d
Cleared Oct 17, 2002
DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414
K012816
Dynarex Corp.
General & Plastic Surgery · 421d
Cleared Jun 21, 2002
ABSORBENT ANTIMICROBIAL WOUND DRESSING
K013814
Convatec, A Division of E.R. Squibb & Sons
General & Plastic Surgery · 217d
Cleared Jun 07, 2000
ACTICOAT PRIMARY ANTIMICROBIAL DRESSING
K992221
Westaim Biomedical, Inc.
General & Plastic Surgery · 342d
Cleared Apr 17, 2000
ACRYDERM SILVER ANTI-MICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044, 1045
K991818
Acrymed, Inc.
General & Plastic Surgery · 326d
Cleared Dec 30, 1999
SALJET SINGLE DOSE STERILE SALINE TOPICAL SOLUTION
K993969
Winchester Laboratories, LLC
General & Plastic Surgery · 37d
Cleared Nov 05, 1999
ANTIBACTERIAL ADHESIVE BANDAGE
K992817
William Feinstein & Associates, Inc.
General & Plastic Surgery · 77d
Cleared Sep 24, 1999
SILVERLON WOUND PACKING STRIPS
K984210
Argentum International, LLC
General & Plastic Surgery · 304d
Cleared Sep 17, 1999
ARGLAES-AB ANTIMICROBIAL BARRIER FILM DRESSING & ISLAND DRESSING
K990810
Maersk Medical, Ltd.
General & Plastic Surgery · 190d
Cleared Aug 12, 1999
SURESKIN II STANDARD, SURESKIN II BORDER, SURESKIN II THIN
K992363
Euromed, Inc.
General & Plastic Surgery · 28d
Cleared Jun 29, 1999
SPYROGEL HYDROGEL WOUND AND BURN DRESSING SA
K991287
Advanced Medical Solutions Group Plc
General & Plastic Surgery · 76d
Cleared May 27, 1999
DERMAPHYLYX HYDROCOLLOID WOUND DRESSING, HEALIAN HYDROCOLLOID WOUND DRESSING
K990891
Dermaphylyx, Inc.
General & Plastic Surgery · 71d
Cleared Apr 14, 1999
DUMEX IODOFORM PACKING STRIP
K990332
Dumex Medical Surgical Products, Ltd.
General & Plastic Surgery · 70d
Cleared Mar 19, 1999
SILON DUAL-DRESS
K990042
Bio Med Sciences, Inc.
General & Plastic Surgery · 72d
Cleared Mar 01, 1999
MODIFICATION OF CUTINOVA THIN DRESSING
K984593
Beiersdorf-Jobt, Inc.
General & Plastic Surgery · 63d
Cleared Mar 01, 1999
MODIFICATION OF CUTINOVA HYDRO DRESSING
K984595
Beiersdorf-Jobt, Inc.
General & Plastic Surgery · 63d
Cleared Mar 01, 1999
MODIFICATION OF CUTINOVA CAVITY DRESSING
K984597
Beiersdorf-Jobt, Inc.
General & Plastic Surgery · 63d
Cleared Mar 01, 1999
MODIFICATION OF CUTINOVA FOAM DRESSING
K984599
Beiersdorf-Jobt, Inc.
General & Plastic Surgery · 63d
Cleared Feb 22, 1999
SILVERLON ISLAND DRESSING, SILVERLON ISLAND PAD
K984208
Argentum International, LLC
General & Plastic Surgery · 90d
Cleared Jan 28, 1999
COMPEED PSORIASIS DRESSING
K982493
Coloplast Corp.
General & Plastic Surgery · 195d
Cleared Dec 16, 1998
BIATAIN FOAM DRESSING
K983163
Coloplast Corp.
General & Plastic Surgery · 97d
Cleared Dec 16, 1998
BIATAIN FOAM ADHESIVE DRESSING
K983173
Coloplast Corp.
General & Plastic Surgery · 97d
Cleared Nov 25, 1998
SURESKIN PLUS STANDARD, SURESKIN PLUS BORDER, SURESKIN PLUS THIN
K983249
Euromed, Inc.
General & Plastic Surgery · 70d
Cleared Sep 25, 1998
SILVERLON CONTACT WOUND DRESSING
K981299
Argentum International, LLC
General & Plastic Surgery · 169d