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FRO

705 FDA 510(k) clearances · Product code

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RecordFirmDate
Clyra Wound Irrigation Solution (K181428)Clyra Medical Technologies, Inc.2019-09-20
Roosin Xeroform Petrolatum Dressing (K181478)Roosin Medical Co., Ltd.2019-09-13
Saline Wound Wash, SteriCleanse(TM) (K183662)Ascent Consumer Products, Inc.2019-09-12
Suprasorb A + Ag “R” (K183208)Speciality Fibres and Materials, Ltd.2019-08-15
Silicone PHMB Foam Wound Dressing (K190819)Advanced Medical Solutions, Ltd.2019-07-25
Silverlon Wound Contact, Burn Contact Dressings (K190343)Argentum Medical, LLC2019-07-18
Apis (K182725)Sweetbio, Inc.2019-05-31
Silver High Performance Dressing (K183645)Advanced Medical Solutions, Ltd.2019-05-29
Medline Burn and Wound Dressing (OTC) (K190224)Medline Industries, Inc.2019-03-08
Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing (K181315)Winner Medical Co., Ltd.2019-02-14
Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing) (K180570)Argentum Medical, LLC2019-01-14
AC5 Topical Gel (K182681)Arch Therapeutics, Inc.2018-12-14
Procellera Composite Antibacterial Wound Dressing (K180533)Vomaris Wound Care, Inc.2018-12-10
KerraContact Ag Perf Advanced Perforated Silver Wound Dressing (K182680)Exciton Technologies, Inc.2018-12-06
MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs) (K180643)Medcu Technologies , Ltd.2018-11-23
AMSure Sterile Water, and Sterile Normal Saline for Wound Flush (K181423)Amsino International, Inc.2018-09-07
Simple Science Antimicrobial Facial and Eyelid Cleanser (K181074)Simple Science, LLC2018-08-17
BIAFINE (K173549)Valeant Pharmaceuticals2018-08-13
Titan Ag 200 (K173844)Specialty Fibres and Materials, Ltd.2018-08-09
Surgical Silver Post Operative Dressing (K180634)Advanced Medical Solutions, Ltd.2018-08-07
PHMB Foam Wound Dressing (K181197)Advanced Medical Solutions, Ltd.2018-08-03
AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber (K173675)Convatec Limited2018-07-20
Medline Burn and Wound Dressing (K173911)Medline Industries, Inc.2018-07-19
Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP (K173276)Medline Industries, Inc.2018-07-02
ALGS6 Ag Alginate Wound Dressing (K172570)Foshan United Medical Technologies, Ltd.2018-05-11
LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing (K172554)Huizhou Foryou Medical Devices Co., Ltd.2018-05-01
HYALURONIC ACID TOPICAL WOUND CREAM (K172747)Virchow Biotech Pvt, Ltd.2018-04-27
Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC) (K180305)Aquilabs Us, LLC2018-04-13
Algidex Ag Silver Alginate Wound Dressing (K173072)Deroyal Industries, Inc.2018-04-04
Microcyn Antimicrobial Hydrogel (K173896)Sonoma Pharmaceuticals, Inc.2018-04-02
Catasyn Advanced Technology Wound Hydrogel (K172338)Synedgen, Inc.2018-02-21
Alevicyn SG Antimicrobial Gel (K171935)Sonoma Pharmaceuticals, Inc.2017-12-01
3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced Securement Dressing (K170754)3M Company, 3M Healthcare2017-11-21
Microcyn Antimicrobial Skin and Wound Cleanser (K172622)Sonoma Pharmaceuticals2017-11-21
Endoform Silver Dermal Template (K172318)Aroa Biosurgery2017-11-17
Microcyn Plus Antimicrobial Wound Care Solution (K172851)Sonoma Pharmaceuticals, Inc.2017-11-15
Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 120 mL cup, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 100mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 250mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 500mL bottle (K172486)Anexa Biomedical, Inc.2017-09-21
Hexagen Derm (K171191)Global Health Solutions, LLC2017-08-25
SilverSeal (K171041)Alliqua Biomedical, Inc.2017-08-22
NEOCERA Advanced Barrier Cream (K170911)Exeltis USA Dermatology, LLC2017-08-22
Sorbact Wound Dressing-Ribbon Gauze (K171225)Abigo Medical AB2017-08-21
Hydrocleanse Antimicrobial Skin and Wound Care Solution (K171727)Sonoma Pharmaceuticals2017-07-26
PHMB Antimicrobial Foam Wound Dressing (K163062)Advanced Medical Solutions, Ltd.2017-07-25
BD ChloraShield IV Dressing with CHG Antimicrobial (K170407)Avery Dennison Belgie Bvba2017-07-17
Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline (K170270)Ls Scientific Inc. D.B.A. Kse Scientific2017-06-23
Cerdak Basic (K153138)Bu Polysciences Equipment & Trading, LLC2017-06-23
Prontosan Wound Gel (K163430)B.Braun Medical, Inc.2017-05-23
Ross Ru Wound Dressing Gel (K162017)Biotd S.A.2017-04-20
LUOFUCON Silicone Ag Foam Dressing with Border (K170077)Huizhou Foryou Medical Devices Co., Ltd.2017-03-30
ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG (10cm x 25cm) (K163529)Avery Dennison Corporation2017-03-29
LOYON (K162217)Oculus Innovative Sciences2017-03-23
Next Science Wound Gel (Rx) (K163188)Next Science, LLC2017-03-06
Curasite (K161991)Izun Pharmaceuticals2017-03-03
KerraCel Ag Gelling Fiber Silver Dressing (K162508)Exciton Technologies, Inc.2017-02-13
Talymed Suspension (K160695)Marine Polymer Technologies, Inc.2016-12-06
PolyPlex Wound Dressing (K160872)Global Health Solutions, LLC2016-11-23
Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL (K161623)B.Braun Medical, Inc.2016-11-10
Xonrid Gel (K152533)Helsinn Healthcare SA2016-10-28
Dynarex Xeroform Petrolatum Dressing (K152970)Dynarex Corporation2016-10-03
Atteris Antimicrobial Skin Protectant (K161212)Rochal Industries, LLC2016-09-30
DONASORB SILVER WOUND DRESSING (K153565)Virchow Biotech Pvt, Ltd.2016-09-22
ACTICOAT Surgical Dressing (K153723)Smith & Nephew Medical Limited2016-09-14
Anexa Wound Flush, Sterile Water & Sterile Normal Saline (K161658)Anexa Biomedical, Inc.2016-09-14
Procellera (K160783)Vomaris Innovations, Inc.2016-09-07
USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9% sodium chloride), 120 mL cup, USP Sterile Water, 100 mL,250 mL and 500 mL bottles, USP Sterile Normal Saline (0.9% sodium chloride), 100 mL, 250 mL and 500 mL bottles (K161311)Strukmyer Medical, LLC2016-08-29
Exufiber Ag+ (K160379)Molnlycke Health Care Us, LLC2016-08-25
Microcyn Plus Wound Care Solution (K161034)Oculus Innovative Sciences2016-08-19
LUOFUCON Silicone Ag foam dressing (K160022)Huizhou Foryou Medical Devices Co., Ltd.2016-08-17
PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove (K153678)Permeaderm, Inc.2016-08-08
Microlyte Ag (K153756)Imbed Biosciences, Inc.2016-08-04
DURAFIBER Ag (K161289)Smith & Nephew Medical Limited2016-08-03
Atteris Antimicrobial Skin & Wound Cleanser (K160192)Rochal Industries, LLC2016-07-28
Dakin's Skin and Wound Cleanser (K150208)Century Pharmaceuticals, Inc.2016-07-21
Sorbact Foam Gentle Border, Sorbact Superabsorbent (K153674)Abigo Medical AB2016-07-01
Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial Wound & Skin Cleanser 8oz, Simple Science Antimicrobial Wound & Skin Cleanser 16oz, Simple Science Antimicrobial Wound & Skin Cleanser 23oz (K160095)Simple Science, LLC2016-06-10
MTR550 (Tentative) Antimicrobial Silver Wound Gel (K152519)Medical Technology Research, Inc.2016-06-02
Agem Ag Mesh Dressing with Silver (K152544)Shenzhen Yuanxing Nano-Pharma Co., Ltd.2016-05-23
Dash-Topic Plus Cream (K150914)Founders Science Group, LLC2016-04-21
Microcyn Plus Skin and Wound Hydrogel (K153648)Oculus Innovative Sciences2016-04-19
Nutraseb Facial Cream (K143605)Isdin Corp.2016-04-14
AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX Wound Wash Skin and Wound Cleanser (OTC) (K151185)Abl Medical, LLC2016-02-05
AQUACEL Ag Surgical SP Dressing (K152926)Convatec Limited2016-01-21
L-Mesitran Dressing Family II- Soft and Tulle (K150676)Theo Manufacturing BV2015-12-23
Nexodyn AOS Wound Care Solution (K151168)Apr Applied Pharma Research SA2015-12-22
Next Science Wound Gel (K150792)Next Science, LLC2015-12-17
Alevicyn SG Antipruritic Gel (K152945)Oculus Innovative Sciences2015-12-15
Stay Fresh Hydrocolloid dressing (K151186)Sarasota Medical Products, Inc.2015-11-27
Ceramax Skin Barrier Cream (K152055)Oculus Innovative Sciences2015-11-23
Puracyn(R) Plus Duo-Care(TM) Antimicrobial Wound & Skin Hydrogel, Puracyn(R) Plus Antimicrobial Hydrogel Professional Formula (K150799)Innovacyn, Inc.2015-11-19
Medihoney Wound Gel (K150985)Derma Sciences, Inc.2015-11-19
BD ChloraShield IV Dressing with CHG Antimicrobial (K152923)Avery Dennison Belgie Bvba2015-11-05
CleanSmart Wound Cleanser (K142592)Simple Science, LLC2015-09-02
SynePure Wound Cleanser (K143444)Synedgen, Inc.2015-08-21
Urgoclean Ag, Antibacterial Absorbent Wound Dressing with Silver (K143017)Laboratoires Urgo2015-08-07
PROTOCOL Incision Dressing (K142962)Deroyal Industries2015-07-23
MEDIHONEY WOUND DRESSINGS (K133279)Derma Sciences, Inc.2015-06-25
Alevicyn SG Antipruritic Gel (K143590)Oculus Innovative Sciences2015-06-04
SPB SKIN EMULSION (K141637)Biotd S.A.2015-06-03
Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with Preservative (OTC) (K143335)Roosin Medical Devices Co., Ltd.2015-06-01
PURICORE WOUND HYDROGEL SPRAY DRESSING (K141863)Puricore, Inc.2015-05-14
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