Product code FRO · Class U
Dressing, Wound, Drug
19510(k)s in 12 months (707 all time)
7recalls in 12 months (82 all time)
56recalls that name a 510(k)
Top companies in FRO
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 11, 2024 | K231088 | Copper Foam Dressing (Prescription and OTC) Roosin Medical Co., Ltd., CN | FRO |
| Jan 4, 2024 | K221110 | LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber Cover Dressing Huizhou Foryou Medical Devices Co., Ltd., CN | FRO |
| Dec 21, 2023 | K223359 | LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing Huizhou Foryou Medical Devices Co., Ltd., CN | FRO |
| Dec 1, 2023 | K231057 | Antibacterial Gel Wound Dressing Winner Medical Co., Ltd., CN | FRO |
| Nov 17, 2023 | K230190 | Polyver Silver Alginate Dressing (Prescription and OTC) Roosin Medical Co., Ltd., CN | FRO |
| Nov 10, 2023 | K231564 | Skin and Wound Cleanser Winner Medical Co., Ltd., CN | FRO |
| Oct 26, 2023 | K213473 | Antimicrobial Gelling Fiber Dressing with PHMB Advanced Medical Solutions, Ltd., GB | FRO |
| Oct 13, 2023 | K222143 | APIS (R), VERIS (TM) Sweetbio, Inc. | FRO |
| Oct 11, 2023 | K222025 | G4Derm / G4Derm Plus Synthetic Wound Matrix Gel4med, Inc. | FRO |
| Sep 29, 2023 | K221570 | Antibacterial bandage Allmed Medical Products Co., Ltd., CN | FRO |
| Aug 18, 2023 | K223526 | ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Border Sacrum Smith & Nephew Medical Limited, GB | FRO |
| Jun 21, 2023 | K221311 | Antibacterial Bandage Winner Medical Co., Ltd., CN | FRO |
| May 24, 2023 | K223259 | coactiv+ Antimicrobial Wound Gel Kane Biotech, Inc., CA | FRO |
| Apr 5, 2023 | K223310 | Antimicrobial Silicone PHMB Foam Wound Dressing Advanced Medical Solutions Limited, GB | FRO |
| Mar 30, 2023 | K223377 | BIASURGE Advanced Surgical Solution Rochal Technologies, LLC | FRO |
| Mar 16, 2023 | K220673 | Sterile Silver Alginate Wound Dressing Qingdao Bright Moon Biomedical Materials Co., Ltd., CN | FRO |
| Jan 30, 2023 | K221532 | PHMB Wound Dressing Winner Medical Co., Ltd., CN | FRO |
| Jan 17, 2023 | K221754 | Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam Dressing (OTC); Silicone Ag Foam Winner Medical Co., Ltd., CN | FRO |
| Jan 13, 2023 | K221755 | Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing Winner Medical Co., Ltd., CN | FRO |
| Jan 13, 2023 | K213514 | Spectricept Skin and Wound Cleanser Spectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc. | FRO |
| Dec 21, 2022 | K221720 | Extra Silver Gelling Fiber Dressing Winner Medical Co., Ltd., CN | FRO |
| Dec 21, 2022 | K220286 | ELECTROCYN soma V3Bio Sdn. Bhd, MY | FRO |
| Oct 26, 2022 | K221218 | Silverlon Wound Contact, Burn Contact Dressings Argentum Medical, Inc. | FRO |
| Oct 18, 2022 | K222657 | MEBO Wound Dressing Mebo Life Science, Inc. | FRO |
| Aug 19, 2022 | K212554 | Bonvadis Topical Cream Stemcyte, Inc. | FRO |
| Apr 22, 2022 | K211123 | LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel Huizhou Foryou Medical Devices Co., Ltd., CN | FRO |
| Mar 23, 2022 | K210718 | LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing Huizhou Foryou Medical Devices Co., Ltd., CN | FRO |
| Feb 24, 2022 | K210135 | PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing 3M Healthcare Business Group, GB | FRO |
| Jan 14, 2022 | K210466 | Silver Gelling Fiber Dressing Winner Medical Co., Ltd., CN | FRO |
| Oct 19, 2021 | K202982 | Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use) Winner Medical Co., Ltd., CN | FRO |
| Sep 23, 2021 | K203446 | TorrentX Wound Wash Next Science, LLC | FRO |
| Sep 1, 2021 | K211972 | Omeza Collagen Matrix Omeza, LLC | FRO |
| May 12, 2021 | K210974 | High Performance Antimicrobial Gelling Fiber with Silver Advanced Medical Solutions, Ltd., GB | FRO |
| Apr 23, 2021 | K203835 | MIS Solution Next Science, LLC | FRO |
| Apr 14, 2021 | K201138 | AMSure® Single Use Saline Topical Solution Amsino Medical, Inc. | FRO |
| Feb 5, 2021 | K201324 | Antibacterial Bandage Jiangsu Excellence Medical Supplies Co., Ltd., CN | FRO |
| Jan 28, 2021 | K201016 | LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC use) Huizhou Foryou Medical Devices Co., Ltd., CN | FRO |
| Oct 19, 2020 | K200821 | anti-bacterial bandage Planet (Suzhou) Medical Products Co., Ltd., CN | FRO |
| Oct 8, 2020 | K200767 | SilverStream Gel Enzysurge , Ltd., IL | FRO |
| Sep 4, 2020 | K200835 | 3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad 3M Company | FRO |
| Sep 4, 2020 | K193439 | MEBO Wound Dressing Mebo Life Science, Inc. | FRO |
| Sep 3, 2020 | K200641 | HaloGUARD Protective Disc with CHG Attwill Medical Solutions | FRO |
| Jun 17, 2020 | K192478 | LT Antibacterial Alginate with Silver Dressing Zhejiang Longterm Medical Technology Co., Ltd., CN | FRO |
| May 14, 2020 | K192463 | PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing w Winner Medical Co., Ltd., CN | FRO |
| May 14, 2020 | K191819 | Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Bord Winner Medical Co., Ltd., CN | FRO |
| May 11, 2020 | K193085 | PuraDERM Gel 3-D Matrix, Inc. | FRO |
| Mar 11, 2020 | K190129 | AC5 Topical Gel Arch Therapeutics, Inc. | FRO |
| Feb 21, 2020 | K191536 | Biatain Silicone Ag Coloplast A/S, DK | FRO |
| Feb 7, 2020 | K192527 | Rochal Antimicrobial Wound Gel Rochal Industries, LLC | FRO |
| Dec 20, 2019 | K190756 | IODOFLEX Smith & Nephew Medical, Ltd., GB | FRO |
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