Product code FRO ยท 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 |
|---|---|---|---|
| May 23, 2017 | K163430 | Prontosan Wound Gel B.Braun Medical, Inc. | FRO |
| Apr 20, 2017 | K162017 | Ross Ru Wound Dressing Gel Biotd S.A., CR | FRO |
| Mar 30, 2017 | K170077 | LUOFUCON Silicone Ag Foam Dressing with Border Huizhou Foryou Medical Devices Co., Ltd., CN | FRO |
| Mar 29, 2017 | K163529 | ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG (10cm x 25cm) Avery Dennison Corporation | FRO |
| Mar 23, 2017 | K162217 | LOYON Oculus Innovative Sciences | FRO |
| Mar 6, 2017 | K163188 | Next Science Wound Gel (Rx) Next Science, LLC | FRO |
| Mar 3, 2017 | K161991 | Curasite Izun Pharmaceuticals | FRO |
| Feb 13, 2017 | K162508 | KerraCel Ag Gelling Fiber Silver Dressing Exciton Technologies, Inc., CA | FRO |
| Dec 6, 2016 | K160695 | Talymed Suspension Marine Polymer Technologies, Inc. | FRO |
| Nov 23, 2016 | K160872 | PolyPlex Wound Dressing Global Health Solutions, LLC | FRO |
| Nov 10, 2016 | K161623 | Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solu B.Braun Medical, Inc. | FRO |
| Oct 28, 2016 | K152533 | Xonrid Gel Helsinn Healthcare SA, CH | FRO |
| Oct 3, 2016 | K152970 | Dynarex Xeroform Petrolatum Dressing Dynarex Corporation | FRO |
| Sep 30, 2016 | K161212 | Atteris Antimicrobial Skin Protectant Rochal Industries, LLC | FRO |
| Sep 22, 2016 | K153565 | DONASORB SILVER WOUND DRESSING Virchow Biotech Pvt, Ltd. | FRO |
| Sep 14, 2016 | K161658 | Anexa Wound Flush, Sterile Water & Sterile Normal Saline Anexa Biomedical, Inc. | FRO |
| Sep 14, 2016 | K153723 | ACTICOAT Surgical Dressing Smith & Nephew Medical Limited, GB | FRO |
| Sep 7, 2016 | K160783 | Procellera Vomaris Innovations, Inc. | FRO |
| Aug 29, 2016 | K161311 | USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9% sodium chloride), 120 mL cup, USP Sterile Water, 100 mL,2 Strukmyer Medical, LLC | FRO |
| Aug 25, 2016 | K160379 | Exufiber Ag+ Molnlycke Health Care Us, LLC | FRO |
| Aug 19, 2016 | K161034 | Microcyn Plus Wound Care Solution Oculus Innovative Sciences | FRO |
| Aug 17, 2016 | K160022 | LUOFUCON Silicone Ag foam dressing Huizhou Foryou Medical Devices Co., Ltd., CN | FRO |
| Aug 8, 2016 | K153678 | PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove Permeaderm, Inc. | FRO |
| Aug 4, 2016 | K153756 | Microlyte Ag Imbed Biosciences, Inc. | FRO |
| Aug 3, 2016 | K161289 | DURAFIBER Ag Smith & Nephew Medical Limited, GB | FRO |
| Jul 28, 2016 | K160192 | Atteris Antimicrobial Skin & Wound Cleanser Rochal Industries, LLC | FRO |
| Jul 21, 2016 | K150208 | Dakin's Skin and Wound Cleanser Century Pharmaceuticals, Inc. | FRO |
| Jul 1, 2016 | K153674 | Sorbact Foam Gentle Border, Sorbact Superabsorbent Abigo Medical AB, SE | FRO |
| Jun 10, 2016 | K160095 | Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial Wound & Skin Cleanser 8oz, Simple S Simple Science, LLC | FRO |
| Jun 2, 2016 | K152519 | MTR550 (Tentative) Antimicrobial Silver Wound Gel Medical Technology Research, Inc. | FRO |
| May 23, 2016 | K152544 | Agem Ag Mesh Dressing with Silver Shenzhen Yuanxing Nano-Pharma Co., Ltd., CN | FRO |
| Apr 21, 2016 | K150914 | Dash-Topic Plus Cream Founders Science Group, LLC | FRO |
| Apr 19, 2016 | K153648 | Microcyn Plus Skin and Wound Hydrogel Oculus Innovative Sciences | FRO |
| Apr 14, 2016 | K143605 | Nutraseb Facial Cream Isdin Corp. | FRO |
| Feb 5, 2016 | K151185 | AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX Wound Wash Skin and Wound Cleanser (OTC) Abl Medical, LLC | FRO |
| Jan 21, 2016 | K152926 | AQUACEL Ag Surgical SP Dressing Convatec Limited, GB | FRO |
| Dec 23, 2015 | K150676 | L-Mesitran Dressing Family II- Soft and Tulle Theo Manufacturing BV, NL | FRO |
| Dec 22, 2015 | K151168 | Nexodyn AOS Wound Care Solution Apr Applied Pharma Research SA, CH | FRO |
| Dec 17, 2015 | K150792 | Next Science Wound Gel Next Science, LLC | FRO |
| Dec 15, 2015 | K152945 | Alevicyn SG Antipruritic Gel Oculus Innovative Sciences | FRO |
| Nov 27, 2015 | K151186 | Stay Fresh Hydrocolloid dressing Sarasota Medical Products, Inc. | FRO |
| Nov 23, 2015 | K152055 | Ceramax Skin Barrier Cream Oculus Innovative Sciences | FRO |
| Nov 19, 2015 | K150985 | Medihoney Wound Gel Derma Sciences, Inc., CA | FRO |
| Nov 19, 2015 | K150799 | Puracyn(R) Plus Duo-Care(TM) Antimicrobial Wound & Skin Hydrogel, Puracyn(R) Plus Antimicrobial Hydrogel Professional F Innovacyn, Inc. | FRO |
| Nov 5, 2015 | K152923 | BD ChloraShield IV Dressing with CHG Antimicrobial Avery Dennison Belgie Bvba, BE | FRO |
| Sep 2, 2015 | K142592 | CleanSmart Wound Cleanser Simple Science, LLC | FRO |
| Aug 21, 2015 | K143444 | SynePure Wound Cleanser Synedgen, Inc. | FRO |
| Aug 7, 2015 | K143017 | Urgoclean Ag, Antibacterial Absorbent Wound Dressing with Silver Laboratoires Urgo, FR | FRO |
| Jul 23, 2015 | K142962 | PROTOCOL Incision Dressing Deroyal Industries | FRO |
| Jun 25, 2015 | K133279 | MEDIHONEY WOUND DRESSINGS Derma Sciences, Inc., CA | FRO |
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