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 Winner Medical Co., Ltd..

707
Total
707
Cleared
187d
Avg days
1978
Since
707 devices
193–216 of 707
Cleared Nov 05, 2015
BD ChloraShield IV Dressing with CHG Antimicrobial
K152923
Avery Dennison Belgie Bvba
General & Plastic Surgery · 31d
Cleared Sep 02, 2015
CleanSmart Wound Cleanser
K142592
Simple Science, LLC
General & Plastic Surgery · 352d
Cleared Aug 21, 2015
SynePure Wound Cleanser
K143444
Synedgen, Inc.
General & Plastic Surgery · 262d
Cleared Aug 07, 2015
Urgoclean Ag, Antibacterial Absorbent Wound Dressing with Silver
K143017
Laboratoires Urgo
General & Plastic Surgery · 291d
Cleared Jul 23, 2015
PROTOCOL Incision Dressing
K142962
Deroyal Industries
General & Plastic Surgery · 282d
Cleared Jun 25, 2015
MEDIHONEY WOUND DRESSINGS
K133279
Derma Sciences, Inc.
General & Plastic Surgery · 609d
Cleared Jun 04, 2015
Alevicyn SG Antipruritic Gel
K143590
Oculus Innovative Sciences
General & Plastic Surgery · 168d
Cleared Jun 03, 2015
SPB SKIN EMULSION
K141637
Biotd S.A.
General & Plastic Surgery · 349d
Cleared Jun 01, 2015
Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with Preservative (OTC)
K143335
Roosin Medical Devices Co., Ltd.
General & Plastic Surgery · 193d
Cleared May 14, 2015
PURICORE WOUND HYDROGEL SPRAY DRESSING
K141863
Puricore, Inc.
General & Plastic Surgery · 308d
Cleared May 08, 2015
DERMAFINE
K140905
Invado Pharmaceuticals
General & Plastic Surgery · 394d
Cleared Apr 30, 2015
SILVERLON BURN CONTACT DRESSINGS
K150256
Argentum Medical
General & Plastic Surgery · 86d
Cleared Apr 20, 2015
IPM Wound Gel Bio, IPM Derm Gel Bio
K143527
Glycobiosciences, Inc.
General & Plastic Surgery · 129d
Cleared Apr 06, 2015
LUOFUCON SILVER FOAM DRESSING
K141619
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 293d
Cleared Mar 23, 2015
LUOFUCON SILVER PU ANTIBACTERIAL FOAM DRESSING
K140954
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 343d
Cleared Feb 13, 2015
Neuwater TM (HydrocynTM aqua)
K142775
Vigilenz Medical Devices
General & Plastic Surgery · 140d
Cleared Feb 13, 2015
PuraDerm Gel
K143058
3-D Matrix, Inc.
General & Plastic Surgery · 112d
Cleared Feb 10, 2015
BIOS KING BIOCELLULOSE FILM
K141382
Coreleader Biotech Co., Ltd.
General & Plastic Surgery · 259d
Cleared Jan 26, 2015
Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact Hydroactive B, Cutimed Siltec Sorbact)
K143151
Bsn Medical GmbH
General & Plastic Surgery · 84d
Cleared Jan 23, 2015
WOUND DRESSING WITH MANUKA HONEY
K133729
Manuka Health New Zealand , Ltd.
General & Plastic Surgery · 413d
Cleared Nov 07, 2014
CHLORADERM ANTIMICROBIAL TRANSPARENT THIN FILM DRESSING, 2 3/8 X 2 3/4, 4 X 4 3/4
K140389
Entrotech Life Sciences, Inc.
General & Plastic Surgery · 266d
Cleared Nov 07, 2014
SILVERLON ISLAND WOUND DRESSING, SILVERLON WOUND PAD DRESSING
K143001
Argentum Medical
General & Plastic Surgery · 21d
Cleared Oct 31, 2014
NAWALUTION SKIN AND WOUND CLEANSER
K141660
Nawa Heilmittel GmbH
General & Plastic Surgery · 133d
Cleared Oct 22, 2014
Ultra Silver Dressings
K141603
Milliken Healthcare Products, LLC
General & Plastic Surgery · 128d