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
49–72 of 707
Cleared Jan 11, 2024
Copper Foam Dressing (Prescription and OTC)
K231088
Roosin Medical Co., Ltd.
General & Plastic Surgery · 269d
Cleared Jan 04, 2024
LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber Cover Dressing
K221110
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 629d
Cleared Dec 21, 2023
LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing
K223359
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 413d
Cleared Dec 01, 2023
Antibacterial Gel Wound Dressing
K231057
Winner Medical Co., Ltd.
General & Plastic Surgery · 232d
Cleared Nov 17, 2023
Polyver Silver Alginate Dressing (Prescription and OTC)
K230190
Roosin Medical Co., Ltd.
General & Plastic Surgery · 297d
Cleared Nov 10, 2023
Skin and Wound Cleanser
K231564
Winner Medical Co., Ltd.
General & Plastic Surgery · 163d
Cleared Oct 26, 2023
Antimicrobial Gelling Fiber Dressing with PHMB
K213473
Advanced Medical Solutions, Ltd.
General & Plastic Surgery · 728d
Cleared Oct 13, 2023
APIS (R), VERIS (TM)
K222143
Sweetbio, Inc.
General & Plastic Surgery · 450d
Cleared Oct 11, 2023
G4Derm / G4Derm Plus Synthetic Wound Matrix
K222025
Gel4med, Inc.
General & Plastic Surgery · 457d
Cleared Sep 29, 2023
Antibacterial bandage
K221570
Allmed Medical Products Co., Ltd.
General & Plastic Surgery · 486d
Cleared Aug 18, 2023
ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Border Sacrum Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Surgical Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing
K223526
Smith & Nephew Medical Limited
General & Plastic Surgery · 268d
Cleared Jun 21, 2023
Antibacterial Bandage
K221311
Winner Medical Co., Ltd.
General & Plastic Surgery · 412d
Cleared May 24, 2023
coactiv+™ Antimicrobial Wound Gel
K223259
Kane Biotech, Inc.
General & Plastic Surgery · 212d
Cleared Apr 05, 2023
Antimicrobial Silicone PHMB Foam Wound Dressing
K223310
Advanced Medical Solutions Limited
General & Plastic Surgery · 159d
Cleared Mar 30, 2023
BIASURGE Advanced Surgical Solution
K223377
Rochal Technologies, LLC
General & Plastic Surgery · 146d
Cleared Mar 16, 2023
Sterile Silver Alginate Wound Dressing
K220673
Qingdao Bright Moon Biomedical Materials Co., Ltd.
General & Plastic Surgery · 374d
Cleared Jan 30, 2023
PHMB Wound Dressing
K221532
Winner Medical Co., Ltd.
General & Plastic Surgery · 249d
Cleared Jan 17, 2023
Ag Foam Dressing Non-Adhesive (OTC)
K221754
Winner Medical Co., Ltd.
General & Plastic Surgery · 215d
Cleared Jan 13, 2023
Spectricept Skin and Wound Cleanser
K213514
Spectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc.
General & Plastic Surgery · 437d
Cleared Jan 13, 2023
Antimicrobial gauze sponge dressing
K221755
Winner Medical Co., Ltd.
General & Plastic Surgery · 211d
Cleared Dec 21, 2022
ELECTROCYN soma
K220286
V3Bio Sdn. Bhd
General & Plastic Surgery · 323d
Cleared Dec 21, 2022
Extra Silver Gelling Fiber Dressing
K221720
Winner Medical Co., Ltd.
General & Plastic Surgery · 191d
Cleared Oct 26, 2022
Silverlon Wound Contact, Burn Contact Dressings
K221218
Argentum Medical, Inc.
General & Plastic Surgery · 182d
Cleared Oct 18, 2022
MEBO Wound Dressing
K222657
Mebo Life Science, Inc.
General & Plastic Surgery · 46d