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
25–48 of 707
Cleared Mar 13, 2025
SiOxC Cream
K242406
Sioxmed, LLC
General & Plastic Surgery · 211d
Cleared Mar 06, 2025
Sterile Water USP and Sterile 0.9% Normal Saline USP
K243001
Laboratorios Biogalenic S.A. DE C.V.
General & Plastic Surgery · 161d
Cleared Dec 16, 2024
LUOFUCON® Silver Collagen Dressing
K240809
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 266d
Cleared Dec 09, 2024
Atrauman® Ag
K242758
Hartmann USA, Inc.
General & Plastic Surgery · 88d
Cleared Nov 13, 2024
LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer)
K242856
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 54d
Cleared Nov 08, 2024
Microdacyn Hydrogel
K240510
Sonoma Pharmaceuticals, Inc.
General & Plastic Surgery · 260d
Cleared Oct 31, 2024
Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo
K243181
Bionova Medical, Inc.
General & Plastic Surgery · 31d
Cleared Oct 21, 2024
Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag 120, 160, 200 4x5 inch, Venus Ag 120, 160, 200 6x6 inch,Venus Ag 120, 160, 200 1x18 inch
K222740
Speciality Fibres and Materials, Ltd.
General & Plastic Surgery · 773d
Cleared Oct 17, 2024
Microlyte Ag/Lidocaine
K211943
Imbed Biosciences
General & Plastic Surgery · 1212d
Cleared Oct 07, 2024
LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use)
K240485
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 230d
Cleared Sep 20, 2024
Derma-R Cream (Derma-R Cream)
K240722
Raya Pharmaceuticals, LLC
General & Plastic Surgery · 186d
Cleared Sep 13, 2024
Microdacyn Wound Care Solution
K233399
Sonoma Pharmaceuticals, Inc.
General & Plastic Surgery · 345d
Cleared Aug 21, 2024
Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo
K240298
Bionova Medical, Inc.
General & Plastic Surgery · 202d
Cleared Jul 31, 2024
Silverlon® Wound Contact, Burn Contact Dressing
K241225
Argentum Medical, LLC
General & Plastic Surgery · 90d
Cleared Jul 19, 2024
coactiv+™ Antimicrobial Wound Gel
K241809
Kane Biotech, Inc.
General & Plastic Surgery · 28d
Cleared Jul 18, 2024
Field Shield Wound Dressing
K212521
Kericure, Inc.
General & Plastic Surgery · 1073d
Cleared Jun 18, 2024
Irrisept Antimicrobial Wound Lavage
K240552
Irrimax Corporation
General & Plastic Surgery · 111d
Cleared May 31, 2024
Puracyn® Plus Antimicrobial Irrigation Solution
K232080
Innovacyn, Inc.
General & Plastic Surgery · 323d
Cleared May 31, 2024
Anti-bacterial bandage
K232333
Jinhua Jingdi Medical Supplies Co., Ltd.
General & Plastic Surgery · 301d
Cleared May 24, 2024
ALGS2 Ag Alginate Wound Dressing Rx
K233111
Foshan United Medical Technologies, Ltd.
General & Plastic Surgery · 240d
Cleared May 22, 2024
Bonvadis®
K232655
Stemcyte, Inc.
General & Plastic Surgery · 265d
Cleared Mar 27, 2024
LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing
K223360
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 510d
Cleared Mar 26, 2024
PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC)
K233151
Medline Industries, LP
General & Plastic Surgery · 181d
Cleared Mar 22, 2024
Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in)
K231953
Coloplast Corp.
General & Plastic Surgery · 266d