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
217–240 of 707
Cleared Aug 28, 2014
SILVERLON ISLAND WOUND DRESSING
K141573
Argentum Medical
General & Plastic Surgery · 77d
Cleared Aug 21, 2014
IONSIL GEL
K132326
Virchow Biotech Pvt, Ltd.
General & Plastic Surgery · 391d
Cleared Aug 08, 2014
HYDROCLEANSE WOUND CARE SOLUTION
K141012
Oculus Innovative Sciences
General & Plastic Surgery · 109d
Cleared Jun 19, 2014
HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER
K132891
The Hymed Group Corp.
General & Plastic Surgery · 276d
Cleared May 20, 2014
ASAP OTC WOUND DRESSING GEL
K140483
Abl Medical, LLC
General & Plastic Surgery · 83d
Cleared May 12, 2014
ROSS RU SKIN DISCONTINUITIES
K131176
Biotd S.A.
General & Plastic Surgery · 382d
Cleared May 02, 2014
MANUKA FOAM HC, MANUKA FOAM HC (WITH ACRYLIC ADHESIVE BORDER), MANUKA FOAM HC (WITH SILICONE ADHESIVE BORDER)
K133934
Links Medical Products, Inc.
General & Plastic Surgery · 130d
Cleared May 01, 2014
SILVERLON ISLAND WOUND DRESSING
K122817
Argentum Medical, LLC
General & Plastic Surgery · 594d
Cleared Apr 28, 2014
PURACYN PLUS SKIN AND WOUND
K133542
Innovacyn, Inc.
General & Plastic Surgery · 161d
Cleared Apr 22, 2014
BCT ANTIMICROBIAL DRESSING & BCT SILVER BANDAGE
K140147
Bio-Medical Carbon Technology Co., Ltd.
General & Plastic Surgery · 90d
Cleared Mar 31, 2014
VASHE WOUND SOLUTION (4.0 OZ), (8.5 OZ & (16.0 OZ)
K131848
Puricore, Inc.
General & Plastic Surgery · 283d
Cleared Mar 26, 2014
EXSALT SD7 WOUND DRESSING WITH ADHESIVE BACKING
K133775
Exciton Technologies, Inc.
General & Plastic Surgery · 104d
Cleared Mar 14, 2014
MANUKA FILL WOUND DRESSING
K131796
Links Medical Products, Inc.
General & Plastic Surgery · 269d
Cleared Mar 13, 2014
CHLORASHIELD IV DRESSING WITH CHG ANTIMICROBIAL
K133764
Avery Dennison Belgie Bvba
General & Plastic Surgery · 92d
Cleared Mar 03, 2014
IPM WOUND GEL BIO
K123193
Glycobiosciences, Inc.
General & Plastic Surgery · 508d
Cleared Feb 14, 2014
L.A.M. IPM WOUND GEL, IPM DERM GEL
K130781
Glycobiosciences, Inc.
General & Plastic Surgery · 330d
Cleared Feb 12, 2014
MEPITEL AG
K130040
Molnlycke Health Care
General & Plastic Surgery · 401d
Cleared Jan 02, 2014
HYDROFERA BLUE PU BACTERIOSTATIC DRESSING
K130670
Hydrofera, LLC
General & Plastic Surgery · 296d
Cleared Dec 20, 2013
NIVATOPIC PLUS
K132329
Nivagen Pharmaceuticals, Inc.
General & Plastic Surgery · 147d
Cleared Dec 16, 2013
HYALMIX CREAM
K123678
Igi Laboratories, Inc.
General & Plastic Surgery · 381d
Cleared Oct 29, 2013
WOUNDWASH SALINE SPRAY
K123910
Neilmed Pharmaceuticals, Inc.
General & Plastic Surgery · 314d
Cleared Oct 08, 2013
PRONTOSAN WOUND GEL X
K130857
B.Braun Medical, Inc.
General & Plastic Surgery · 194d
Cleared Aug 28, 2013
DERMISEB CREAM
K123724
Igi Laboratories, Inc.
General & Plastic Surgery · 267d
Cleared Aug 07, 2013
PROTHELIAL
K123904
Mueller Medical International, LLC
General & Plastic Surgery · 231d