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
Aug 19, 2016
Microcyn Plus Wound Care Solution
Oculus Innovative Sciences
General & Plastic Surgery
128d
Cleared
Aug 17, 2016
LUOFUCON Silicone Ag foam dressing
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery
225d
Cleared
Aug 08, 2016
PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove
Permeaderm, Inc.
General & Plastic Surgery
231d
Cleared
Aug 04, 2016
Microlyte Ag
Imbed Biosciences, Inc.
General & Plastic Surgery
218d
Cleared
Aug 03, 2016
DURAFIBER Ag
Smith & Nephew Medical Limited
General & Plastic Surgery
86d
Cleared
Jul 28, 2016
Atteris Antimicrobial Skin & Wound Cleanser
Rochal Industries, LLC
General & Plastic Surgery
183d
Cleared
Jul 21, 2016
Dakin's Skin and Wound Cleanser
Century Pharmaceuticals, Inc.
General & Plastic Surgery
538d
Cleared
Jul 01, 2016
Sorbact Foam Gentle Border, Sorbact Superabsorbent
Abigo Medical AB
General & Plastic Surgery
193d
Cleared
Jun 10, 2016
Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial Wound & Skin Cleanser 8oz, Simple Science Antimicrobial Wound & Skin Cleanser 16oz, Simple Science Antimicrobial Wound & Skin Cleanser 23oz
Simple Science, LLC
General & Plastic Surgery
143d
Cleared
Jun 02, 2016
MTR550 (Tentative) Antimicrobial Silver Wound Gel
Medical Technology Research, Inc.
General & Plastic Surgery
273d
Cleared
May 23, 2016
Agem Ag Mesh Dressing with Silver
Shenzhen Yuanxing Nano-Pharma Co., Ltd.
General & Plastic Surgery
262d
Cleared
Apr 21, 2016
Dash-Topic Plus Cream
Founders Science Group, LLC
General & Plastic Surgery
381d
Cleared
Apr 19, 2016
Microcyn Plus Skin and Wound Hydrogel
Oculus Innovative Sciences
General & Plastic Surgery
120d
Cleared
Apr 14, 2016
Nutraseb Facial Cream
Isdin Corp.
General & Plastic Surgery
482d
Cleared
Feb 05, 2016
AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX Wound Wash Skin and Wound Cleanser (OTC)
Abl Medical, LLC
General & Plastic Surgery
277d
Cleared
Jan 21, 2016
AQUACEL Ag Surgical SP Dressing
Convatec Limited
General & Plastic Surgery
108d
Cleared
Dec 23, 2015
L-Mesitran Dressing Family II- Soft and Tulle
Theo Manufacturing BV
General & Plastic Surgery
282d
Cleared
Dec 22, 2015
Nexodyn AOS Wound Care Solution
Apr Applied Pharma Research SA
General & Plastic Surgery
235d
Cleared
Dec 17, 2015
Next Science Wound Gel
Next Science, LLC
General & Plastic Surgery
267d
Cleared
Dec 15, 2015
Alevicyn SG Antipruritic Gel
Oculus Innovative Sciences
General & Plastic Surgery
70d
Cleared
Nov 27, 2015
Stay Fresh Hydrocolloid dressing
Sarasota Medical Products, Inc.
General & Plastic Surgery
207d
Cleared
Nov 23, 2015
Ceramax Skin Barrier Cream
Oculus Innovative Sciences
General & Plastic Surgery
122d
Cleared
Nov 19, 2015
Puracyn(R) Plus Duo-Care(TM) Antimicrobial Wound & Skin Hydrogel, Puracyn(R) Plus Antimicrobial Hydrogel Professional Formula
Innovacyn, Inc.
General & Plastic Surgery
238d
Cleared
Nov 19, 2015
Medihoney Wound Gel
Derma Sciences, Inc.
General & Plastic Surgery
219d