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 |
|---|---|---|---|
| Dec 20, 2019 | K190730 | IODOSORB Smith & Nephew Medical, Ltd., GB | FRO |
| Nov 6, 2019 | K190268 | Hydrofera Blue READY - Border Hydrofera, LLC | FRO |
| Oct 18, 2019 | K190342 | BIAFINE Topical Cream Bausch Health Americas Incorporated | FRO |
| Oct 11, 2019 | K183681 | Protego Antimicrobial Wound Dressing Global Health Solutions (Dba Turn Therapeutics) | FRO |
| Sep 20, 2019 | K181428 | Clyra Wound Irrigation Solution Clyra Medical Technologies, Inc. | FRO |
| Sep 13, 2019 | K181478 | Roosin Xeroform Petrolatum Dressing Roosin Medical Co., Ltd., CN | FRO |
| Sep 12, 2019 | K183662 | Saline Wound Wash, SteriCleanse(TM) Ascent Consumer Products, Inc. | FRO |
| Aug 15, 2019 | K183208 | Suprasorb A + Ag R Speciality Fibres and Materials, Ltd., GB | FRO |
| Jul 25, 2019 | K190819 | Silicone PHMB Foam Wound Dressing Advanced Medical Solutions, Ltd., GB | FRO |
| Jul 18, 2019 | K190343 | Silverlon Wound Contact, Burn Contact Dressings Argentum Medical, LLC | FRO |
| May 31, 2019 | K182725 | Apis Sweetbio, Inc. | FRO |
| May 29, 2019 | K183645 | Silver High Performance Dressing Advanced Medical Solutions, Ltd., GB | FRO |
| Mar 8, 2019 | K190224 | Medline Burn and Wound Dressing (OTC) Medline Industries, Inc. | FRO |
| Feb 14, 2019 | K181315 | Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing Winner Medical Co., Ltd., CN | FRO |
| Jan 14, 2019 | K180570 | Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing) Argentum Medical, LLC | FRO |
| Dec 14, 2018 | K182681 | AC5 Topical Gel Arch Therapeutics, Inc. | FRO |
| Dec 10, 2018 | K180533 | Procellera Composite Antibacterial Wound Dressing Vomaris Wound Care, Inc. | FRO |
| Dec 6, 2018 | K182680 | KerraContact Ag Perf Advanced Perforated Silver Wound Dressing Exciton Technologies, Inc., CA | FRO |
| Nov 23, 2018 | K180643 | MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs) Medcu Technologies , Ltd., IL | FRO |
| Sep 7, 2018 | K181423 | AMSure Sterile Water, and Sterile Normal Saline for Wound Flush Amsino International, Inc. | FRO |
| Aug 17, 2018 | K181074 | Simple Science Antimicrobial Facial and Eyelid Cleanser Simple Science, LLC | FRO |
| Aug 13, 2018 | K173549 | BIAFINE Valeant Pharmaceuticals | FRO |
| Aug 9, 2018 | K173844 | Titan Ag 200 Specialty Fibres and Materials, Ltd., GB | FRO |
| Aug 7, 2018 | K180634 | Surgical Silver Post Operative Dressing Advanced Medical Solutions, Ltd., GB | FRO |
| Aug 3, 2018 | K181197 | PHMB Foam Wound Dressing Advanced Medical Solutions, Ltd., GB | FRO |
| Jul 20, 2018 | K173675 | AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber Convatec Limited, GB | FRO |
| Jul 19, 2018 | K173911 | Medline Burn and Wound Dressing Medline Industries, Inc. | FRO |
| Jul 2, 2018 | K173276 | Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP Medline Industries, Inc. | FRO |
| May 11, 2018 | K172570 | ALGS6 Ag Alginate Wound Dressing Foshan United Medical Technologies, Ltd., CN | FRO |
| May 1, 2018 | K172554 | LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing Huizhou Foryou Medical Devices Co., Ltd., CN | FRO |
| Apr 27, 2018 | K172747 | HYALURONIC ACID TOPICAL WOUND CREAM Virchow Biotech Pvt, Ltd. | FRO |
| Apr 13, 2018 | K180305 | Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC) Aquilabs Us, LLC | FRO |
| Apr 4, 2018 | K173072 | Algidex Ag Silver Alginate Wound Dressing Deroyal Industries, Inc. | FRO |
| Apr 2, 2018 | K173896 | Microcyn Antimicrobial Hydrogel Sonoma Pharmaceuticals, Inc. | FRO |
| Feb 21, 2018 | K172338 | Catasyn Advanced Technology Wound Hydrogel Synedgen, Inc. | FRO |
| Dec 1, 2017 | K171935 | Alevicyn SG Antimicrobial Gel Sonoma Pharmaceuticals, Inc. | FRO |
| Nov 21, 2017 | K172622 | Microcyn Antimicrobial Skin and Wound Cleanser Sonoma Pharmaceuticals | FRO |
| Nov 21, 2017 | K170754 | 3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced Securement Dressing 3M Company, 3M Healthcare | FRO |
| Nov 17, 2017 | K172318 | Endoform Silver Dermal Template Aroa Biosurgery, NZ | FRO |
| Nov 15, 2017 | K172851 | Microcyn Plus Antimicrobial Wound Care Solution Sonoma Pharmaceuticals, Inc. | FRO |
| Sep 21, 2017 | K172486 | Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 120 mL cup, USP Sterile Water Anexa Biomedical, Inc. | FRO |
| Aug 25, 2017 | K171191 | Hexagen Derm Global Health Solutions, LLC | FRO |
| Aug 22, 2017 | K171041 | SilverSeal Alliqua Biomedical, Inc. | FRO |
| Aug 22, 2017 | K170911 | NEOCERA Advanced Barrier Cream Exeltis USA Dermatology, LLC | FRO |
| Aug 21, 2017 | K171225 | Sorbact Wound Dressing-Ribbon Gauze Abigo Medical AB, SE | FRO |
| Jul 26, 2017 | K171727 | Hydrocleanse Antimicrobial Skin and Wound Care Solution Sonoma Pharmaceuticals | FRO |
| Jul 25, 2017 | K163062 | PHMB Antimicrobial Foam Wound Dressing Advanced Medical Solutions, Ltd., GB | FRO |
| Jul 17, 2017 | K170407 | BD ChloraShield IV Dressing with CHG Antimicrobial Avery Dennison Belgie Bvba, BE | FRO |
| Jun 23, 2017 | K170270 | Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline Ls Scientific Inc. D.B.A. Kse Scientific | FRO |
| Jun 23, 2017 | K153138 | Cerdak Basic Bu Polysciences Equipment & Trading, LLC | FRO |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.