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
313–336 of 707
Cleared Aug 02, 2006
AGCEL WOUND DRESSING,AGCEL BURN DRESSING
K050842
Modern Medical Equipment Mfg., Ltd.
General & Plastic Surgery · 488d
Cleared May 17, 2006
EUROMED SURESKIN III WITH SILVER WOUND DRESSINGS
K050032
Euromed, Inc.
General & Plastic Surgery · 495d
Cleared Mar 17, 2006
TRIOSYN T40 ANTIMICROBIAL WOUND DRESSING
K051542
Triosyn Corp.
General & Plastic Surgery · 280d
Cleared Feb 17, 2006
BRENNEN MEDICAL SILVER GLUCAN WOUND DRESSING
K050086
Brennen Medical, Inc.
General & Plastic Surgery · 400d
Cleared Feb 03, 2006
SUCRALFATE AND CARAFATE PASTE KITS
K043587
Patrick D. Mcgrath Ph.D
General & Plastic Surgery · 402d
Cleared Dec 16, 2005
3M TEGADERM SILVER (AG) MESH
K053256
3M Company
General & Plastic Surgery · 24d
Cleared Dec 05, 2005
SILVERSEAL SILVERAID WITH X-STATIC
K050726
Noble Fiber Technologies, Inc.
General & Plastic Surgery · 262d
Cleared Nov 08, 2005
FORTADERM ANTIMICROBIAL WOUND DRESSING
K051647
Organogenesis, Inc.
General & Plastic Surgery · 140d
Cleared Oct 20, 2005
MEDLINE IODOFORM PACKING STRIPS
K052720
Medline Industries, Inc.
General & Plastic Surgery · 21d
Cleared Oct 17, 2005
BIODERM SCIENCES WOUND CREAM
K042352
Bioderm Sciences, Inc.
General & Plastic Surgery · 413d
Cleared Aug 22, 2005
MILLIKEN SILVER WOUND DRESSINGS
K051445
Milliken Chemical
General & Plastic Surgery · 81d
Cleared Jun 15, 2005
BIODERM SCIENCES WOUND HEALING SPRAY
K042084
Bioderm Sciences, Inc.
General & Plastic Surgery · 316d
Cleared Jun 13, 2005
SILVERSEAL CONTACTING WOUND DRESSING WITH X-STATIC
K050649
Noble Fiber Technologies, Inc.
General & Plastic Surgery · 91d
Cleared Jun 09, 2005
SILVER ANTIMICROBIAL WOUND GAUZE (SPONGE)
K042164
Medline Industries, Inc.
General & Plastic Surgery · 302d
Cleared Jun 06, 2005
COLACTIVE AG COLLAGEN WITH SILVER ANTIMICROBIAL DRESSING
K043296
Covalontechnologies, Inc.
General & Plastic Surgery · 189d
Cleared May 17, 2005
EPI-MAX
K041059
Dermagenics, Inc.
General & Plastic Surgery · 389d
Cleared May 17, 2005
DERMACYN WOUND IRRIGATION
K042729
Oculus Innovative Sciences, Inc.
General & Plastic Surgery · 228d
Cleared May 03, 2005
MICROCYN WOUND CARE DRESSING
K041161
Oculus Innovative Sciences, Inc.
General & Plastic Surgery · 365d
Cleared Apr 21, 2005
ACTICOAT MOISTURE CONTROL DRESSING
K050030
Smith & Nephew, Inc.
General & Plastic Surgery · 104d
Cleared Dec 01, 2004
MEDTRADE PRODUCTS ANTISEPTIC BARRIER SILVER FOAM DRESSING, MODEL 09912450
K033732
Medtrade Products , Ltd.
General & Plastic Surgery · 369d
Cleared Nov 02, 2004
3M TEGADERM SILVER
K040890
3M Company
General & Plastic Surgery · 223d
Cleared Aug 05, 2004
ANTIMICROBIAL ALGINATE DRESSING
K041316
Advanced Medical Solutions, Ltd.
General & Plastic Surgery · 80d
Cleared May 17, 2004
CONTREET FOAM CAVITY DRESSING WITH SILVER, MODEL 9628 (2X4 IN.)
K033869
Coloplast Corp.
General & Plastic Surgery · 157d
Cleared Oct 22, 2003
FERRIS POLYMEM SILVER WOUND DRESSING
K031307
Ferris Mfg. Corp.
General & Plastic Surgery · 181d