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
Cleared
Jul 25, 2017
PHMB Antimicrobial Foam Wound Dressing
Advanced Medical Solutions, Ltd.
General & Plastic Surgery
265d
Cleared
Jul 17, 2017
BD ChloraShield IV Dressing with CHG Antimicrobial
Avery Dennison Belgie Bvba
General & Plastic Surgery
157d
Cleared
Jun 23, 2017
Cerdak Basic
Bu Polysciences Equipment & Trading, LLC
General & Plastic Surgery
602d
Cleared
Jun 23, 2017
Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline
Ls Scientific Inc. D.B.A. Kse Scientific
General & Plastic Surgery
147d
Cleared
May 23, 2017
Prontosan Wound Gel
B.Braun Medical, Inc.
General & Plastic Surgery
167d
Cleared
Apr 20, 2017
Ross Ru Wound Dressing Gel
Biotd S.A.
General & Plastic Surgery
273d
Cleared
Mar 30, 2017
LUOFUCON Silicone Ag Foam Dressing with Border
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery
80d
Cleared
Mar 29, 2017
ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG (10cm x 25cm)
Avery Dennison Corporation
General & Plastic Surgery
103d
Cleared
Mar 23, 2017
LOYON
Oculus Innovative Sciences
General & Plastic Surgery
227d
Cleared
Mar 06, 2017
Next Science Wound Gel (Rx)
Next Science, LLC
General & Plastic Surgery
112d
Cleared
Mar 03, 2017
Curasite
Izun Pharmaceuticals
General & Plastic Surgery
227d
Cleared
Feb 13, 2017
KerraCel Ag Gelling Fiber Silver Dressing
Exciton Technologies, Inc.
General & Plastic Surgery
158d
Cleared
Dec 06, 2016
Talymed Suspension
Marine Polymer Technologies, Inc.
General & Plastic Surgery
267d
Cleared
Nov 23, 2016
PolyPlex Wound Dressing
Global Health Solutions, LLC
General & Plastic Surgery
238d
Cleared
Nov 10, 2016
Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL
B.Braun Medical, Inc.
General & Plastic Surgery
150d
Cleared
Oct 28, 2016
Xonrid Gel
Helsinn Healthcare SA
General & Plastic Surgery
421d
Cleared
Oct 03, 2016
Dynarex Xeroform Petrolatum Dressing
Dynarex Corporation
General & Plastic Surgery
361d
Cleared
Sep 30, 2016
Atteris Antimicrobial Skin Protectant
Rochal Industries, LLC
General & Plastic Surgery
155d
Cleared
Sep 22, 2016
DONASORB SILVER WOUND DRESSING
Virchow Biotech Pvt, Ltd.
General & Plastic Surgery
283d
Cleared
Sep 14, 2016
ACTICOAT Surgical Dressing
Smith & Nephew Medical Limited
General & Plastic Surgery
261d
Cleared
Sep 14, 2016
Anexa Wound Flush, Sterile Water & Sterile Normal Saline
Anexa Biomedical, Inc.
General & Plastic Surgery
90d
Cleared
Sep 07, 2016
Procellera
Vomaris Innovations, Inc.
General & Plastic Surgery
169d
Cleared
Aug 29, 2016
USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9% sodium chloride), 120 mL cup, USP Sterile Water, 100 mL,250 mL and 500 mL bottles, USP Sterile Normal Saline (0.9% sodium chloride), 100 mL, 250 mL and 500 mL bottles
Strukmyer Medical, LLC
General & Plastic Surgery
111d
Cleared
Aug 25, 2016
Exufiber Ag+
Molnlycke Health Care Us, LLC
General & Plastic Surgery
197d