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
Cleared
Nov 05, 2015
BD ChloraShield IV Dressing with CHG Antimicrobial
Avery Dennison Belgie Bvba
General & Plastic Surgery
31d
Cleared
Sep 02, 2015
CleanSmart Wound Cleanser
Simple Science, LLC
General & Plastic Surgery
352d
Cleared
Aug 21, 2015
SynePure Wound Cleanser
Synedgen, Inc.
General & Plastic Surgery
262d
Cleared
Aug 07, 2015
Urgoclean Ag, Antibacterial Absorbent Wound Dressing with Silver
Laboratoires Urgo
General & Plastic Surgery
291d
Cleared
Jul 23, 2015
PROTOCOL Incision Dressing
Deroyal Industries
General & Plastic Surgery
282d
Cleared
Jun 25, 2015
MEDIHONEY WOUND DRESSINGS
Derma Sciences, Inc.
General & Plastic Surgery
609d
Cleared
Jun 04, 2015
Alevicyn SG Antipruritic Gel
Oculus Innovative Sciences
General & Plastic Surgery
168d
Cleared
Jun 03, 2015
SPB SKIN EMULSION
Biotd S.A.
General & Plastic Surgery
349d
Cleared
Jun 01, 2015
Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with Preservative (OTC)
Roosin Medical Devices Co., Ltd.
General & Plastic Surgery
193d
Cleared
May 14, 2015
PURICORE WOUND HYDROGEL SPRAY DRESSING
Puricore, Inc.
General & Plastic Surgery
308d
Cleared
May 08, 2015
DERMAFINE
Invado Pharmaceuticals
General & Plastic Surgery
394d
Cleared
Apr 30, 2015
SILVERLON BURN CONTACT DRESSINGS
Argentum Medical
General & Plastic Surgery
86d
Cleared
Apr 20, 2015
IPM Wound Gel Bio, IPM Derm Gel Bio
Glycobiosciences, Inc.
General & Plastic Surgery
129d
Cleared
Apr 06, 2015
LUOFUCON SILVER FOAM DRESSING
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery
293d
Cleared
Mar 23, 2015
LUOFUCON SILVER PU ANTIBACTERIAL FOAM DRESSING
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery
343d
Cleared
Feb 13, 2015
Neuwater TM (HydrocynTM aqua)
Vigilenz Medical Devices
General & Plastic Surgery
140d
Cleared
Feb 13, 2015
PuraDerm Gel
3-D Matrix, Inc.
General & Plastic Surgery
112d
Cleared
Feb 10, 2015
BIOS KING BIOCELLULOSE FILM
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)
Bsn Medical GmbH
General & Plastic Surgery
84d
Cleared
Jan 23, 2015
WOUND DRESSING WITH MANUKA HONEY
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
Entrotech Life Sciences, Inc.
General & Plastic Surgery
266d
Cleared
Nov 07, 2014
SILVERLON ISLAND WOUND DRESSING, SILVERLON WOUND PAD DRESSING
Argentum Medical
General & Plastic Surgery
21d
Cleared
Oct 31, 2014
NAWALUTION SKIN AND WOUND CLEANSER
Nawa Heilmittel GmbH
General & Plastic Surgery
133d
Cleared
Oct 22, 2014
Ultra Silver Dressings
Milliken Healthcare Products, LLC
General & Plastic Surgery
128d