Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- MiscellaneousMiscellaneous
- MVFSystem, Laser, Photodynamic Therapy3Product Code
- MVGSystem, Laser, Fiber Optic, Photodynamic Therapy3Product Code
- MWZExpander, Breast, ExternalUProduct Code
- MYHSystem, Non-Coherent Light, Photodynamic Therapy3Product Code
- NBESealant, Polymerizing3Product Code
- PBDComposite Cultured SkinFProduct Code
- QPEPhototherapy Device For Reducing The Appearance Of Acute Post-Surgical Incisions2Product Code
- MTJWax, BoneUProduct Code
- DTHSuture, Cardiovascular3Product Code
- DZGSuture, Dental3Product Code
- EFQGauze/Sponge, InternalUProduct Code
- EYFProtector, Wound, PlasticUProduct Code
- FRODressing, Wound, DrugUProduct Code
- K243001Sterile Water USP and Sterile 0.9% Normal Saline USPUCleared 510(K)
- K240809LUOFUCON® Silver Collagen DressingUCleared 510(K)
- K242758Atrauman® AgUCleared 510(K)
- K242856LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer)UCleared 510(K)
- K240510Microdacyn HydrogelUCleared 510(K)
- K243181Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloUCleared 510(K)
- K222740Venus 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 inchUCleared 510(K)
- K211943Microlyte Ag/LidocaineUCleared 510(K)
- K240485LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use)UCleared 510(K)
- K240722Derma-R Cream (Derma-R Cream)UCleared 510(K)
- K233399Microdacyn Wound Care SolutionUCleared 510(K)
- K240298Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoUCleared 510(K)
- K241225Silverlon® Wound Contact, Burn Contact DressingUCleared 510(K)
- K241809coactiv+™ Antimicrobial Wound GelUCleared 510(K)
- K212521Field Shield Wound DressingUCleared 510(K)
- K241660SiOxD® Wound MatrixUCleared 510(K)
- K240552Irrisept Antimicrobial Wound LavageUCleared 510(K)
- K232333Anti-bacterial bandageUCleared 510(K)
- K232080Puracyn® Plus Antimicrobial Irrigation SolutionUCleared 510(K)
- K233111ALGS2 Ag Alginate Wound Dressing Rx; ALGS2 Ag Alginate Wound Dressing OTC; ALGS2S Re-enforced Ag Alginate Wound Dressing Rx; ALGS2S Re-enforced Ag Alginate Wound Dressing OTCUCleared 510(K)
- K232655Bonvadis®UCleared 510(K)
- K223360LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam DressingUCleared 510(K)
- K233151PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC)UCleared 510(K)
- K231953Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - 10 cm x 12 cm / 4 in x 5 in); Biatain Fiber Ag (33574 - 15 cm x 15 cm / 6 in x 6 in); Biatain Fiber Ag (33576 - 2.5 cm x 46 cm / 1 in x 18 in); Biatain Fiber Ag (33578 - 20 cm x 30 cm / 8 in x 12 in)UCleared 510(K)
- K231088Copper Foam Dressing (Prescription and OTC)UCleared 510(K)
- K221110LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber Cover DressingUCleared 510(K)
- K223359LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam DressingUCleared 510(K)
- K232847SiOxD Wound MatrixUCleared 510(K)
- K231057Antibacterial Gel Wound DressingUCleared 510(K)
- K230190Polyver Silver Alginate Dressing (Prescription and OTC)UCleared 510(K)
- K231937Foundation Dermal Regeneration Scaffold (DRS) SoloUCleared 510(K)
- K231564Skin and Wound CleanserUCleared 510(K)
- K213473Antimicrobial Gelling Fiber Dressing with PHMBUCleared 510(K)
- K222143APIS (R), VERIS (TM)UCleared 510(K)
- K222025G4Derm / G4Derm Plus Synthetic Wound MatrixUCleared 510(K)
- K221570Antibacterial bandageUCleared 510(K)
- K213413Hemostatic DressingUCleared 510(K)
- K212766Maxiocel Chitosan Wound DressingUCleared 510(K)
- K223526ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Border Sacrum Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Surgical Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam DressingUCleared 510(K)
- K213652Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG)UCleared 510(K)
- K221311Antibacterial BandageUCleared 510(K)
- K223259coactiv+™ Antimicrobial Wound GelUCleared 510(K)
- K223725Restrata® MiniMatrixUCleared 510(K)
- K223495Zeolite Hemostatic CottonUCleared 510(K)
- K222909Axiostat GauzeUCleared 510(K)
- K223310Antimicrobial Silicone PHMB Foam Wound DressingUCleared 510(K)
- K223377BIASURGE Advanced Surgical SolutionUCleared 510(K)
- K220673Sterile Silver Alginate Wound DressingUCleared 510(K)
- K210751S.E.A.L. Hemostatic Wound SprayUCleared 510(K)
- K221532PHMB Wound DressingUCleared 510(K)
- K221754Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam Dressing (OTC); Silicone Ag Foam Dressing with Border (OTC)UCleared 510(K)
- K221755Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressingUCleared 510(K)
- K213514Spectricept Skin and Wound CleanserUCleared 510(K)
- K221720Extra Silver Gelling Fiber DressingUCleared 510(K)
- K220286ELECTROCYN somaUCleared 510(K)
- K222189SiOxD Wound MatrixUCleared 510(K)
- K221218Silverlon Wound Contact, Burn Contact DressingsUCleared 510(K)
- K222657MEBO Wound DressingUCleared 510(K)
- K212554Bonvadis Topical CreamUCleared 510(K)
- K210949Foundation Dermal Regeneration Scaffold (DRS) SoloUCleared 510(K)
- K220566Vascette HP (hemostatic pad)UCleared 510(K)
- K211123LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound GelUCleared 510(K)
- K210718LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber DressingUCleared 510(K)
- K210135PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large DressingUCleared 510(K)
- K210466Silver Gelling Fiber DressingUCleared 510(K)
- K202982Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use)UCleared 510(K)
- K203446TorrentX Wound WashUCleared 510(K)
- K211972Omeza Collagen MatrixUCleared 510(K)
- K210974High Performance Antimicrobial Gelling Fiber with SilverUCleared 510(K)
- K203835MIS SolutionUCleared 510(K)
- K201138AMSure® Single Use Saline Topical SolutionUCleared 510(K)
- K201324Antibacterial BandageUCleared 510(K)
- K201016LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC use)UCleared 510(K)
- K200821anti-bacterial bandageUCleared 510(K)
- K200767SilverStream GelUCleared 510(K)
- K2008353M Tegaderm CHG Chlorhexidine Gluconate Gel PadUCleared 510(K)
- K193439MEBO Wound DressingUCleared 510(K)
- K200641HaloGUARD Protective Disc with CHGUCleared 510(K)
- K192478LT Antibacterial Alginate with Silver DressingUCleared 510(K)
- K192463PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing with BorderUCleared 510(K)
- K191819Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with BorderUCleared 510(K)
- K193085PuraDERM GelUCleared 510(K)
- K190129AC5 Topical GelUCleared 510(K)
- K191536Biatain Silicone AgUCleared 510(K)
- K192527Rochal Antimicrobial Wound GelUCleared 510(K)
- K190756IODOFLEXUCleared 510(K)
- K190730IODOSORBUCleared 510(K)
- K190268Hydrofera Blue READY - BorderUCleared 510(K)
- K190342BIAFINE Topical CreamUCleared 510(K)
- K183681Protego Antimicrobial Wound DressingUCleared 510(K)
- K181428Clyra Wound Irrigation SolutionUCleared 510(K)
- K181478Roosin Xeroform Petrolatum DressingUCleared 510(K)
- K183662Saline Wound Wash, SteriCleanse(TM)UCleared 510(K)
- K183208Suprasorb A + Ag “R”UCleared 510(K)
- K190819Silicone PHMB Foam Wound DressingUCleared 510(K)
- K190343Silverlon Wound Contact, Burn Contact DressingsUCleared 510(K)
- K182725ApisUCleared 510(K)
- K183645Silver High Performance DressingUCleared 510(K)
- K190224Medline Burn and Wound Dressing (OTC)UCleared 510(K)
- K181315Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressingUCleared 510(K)
- K180570Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing)UCleared 510(K)
- K182681AC5 Topical GelUCleared 510(K)
- K180533Procellera Composite Antibacterial Wound DressingUCleared 510(K)
- K182680KerraContact Ag Perf Advanced Perforated Silver Wound DressingUCleared 510(K)
- K180643MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs)UCleared 510(K)
- K181423AMSure Sterile Water, and Sterile Normal Saline for Wound FlushUCleared 510(K)
- K181074Simple Science Antimicrobial Facial and Eyelid CleanserUCleared 510(K)
- K173549BIAFINEUCleared 510(K)
- K173844Titan Ag 200UCleared 510(K)
- K180634Surgical Silver Post Operative DressingUCleared 510(K)
- K181197PHMB Foam Wound DressingUCleared 510(K)
- K173675AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening FiberUCleared 510(K)
- K173911Medline Burn and Wound DressingUCleared 510(K)
- K173276Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USPUCleared 510(K)
- K173005SURECELL Gelling Fiber Wound DressingUCleared 510(K)
- K172570ALGS6 Ag Alginate Wound DressingUCleared 510(K)
- K172554LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate DressingUCleared 510(K)
- K172747HYALURONIC ACID TOPICAL WOUND CREAMUCleared 510(K)
- K180305Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC)UCleared 510(K)
- K173072Algidex Ag Silver Alginate Wound DressingUCleared 510(K)
- K173896Microcyn Antimicrobial HydrogelUCleared 510(K)
- K172338Catasyn Advanced Technology Wound HydrogelUCleared 510(K)
- K172010gel-e BandageUCleared 510(K)
- K171935Alevicyn SG Antimicrobial GelUCleared 510(K)
- K172622Microcyn Antimicrobial Skin and Wound CleanserUCleared 510(K)
- K1707543M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced Securement DressingUCleared 510(K)
- K172318Endoform Silver Dermal TemplateUCleared 510(K)
- K172851Microcyn Plus Antimicrobial Wound Care SolutionUCleared 510(K)
- K172486Anexa 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 bottleUCleared 510(K)
- K171191Hexagen DermUCleared 510(K)
- K171041SilverSealUCleared 510(K)
- K170911NEOCERA Advanced Barrier CreamUCleared 510(K)
- K171225Sorbact Wound Dressing-Ribbon GauzeUCleared 510(K)
- K171727Hydrocleanse Antimicrobial Skin and Wound Care SolutionUCleared 510(K)
- K163062PHMB Antimicrobial Foam Wound DressingUCleared 510(K)
- K170407BD ChloraShield IV Dressing with CHG AntimicrobialUCleared 510(K)
- K1719083M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement DressingUCleared 510(K)
- K170270Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal SalineUCleared 510(K)
- K153138Cerdak BasicUCleared 510(K)
- K163430Prontosan Wound GelUCleared 510(K)
- K1534103M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement DressingUCleared 510(K)
- K162017Ross Ru Wound Dressing GelUCleared 510(K)
- K170077LUOFUCON Silicone Ag Foam Dressing with BorderUCleared 510(K)
- K163529ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG (10cm x 25cm)UCleared 510(K)
- K162217LOYONUCleared 510(K)
- K163188Next Science Wound Gel (Rx)UCleared 510(K)
- K161991CurasiteUCleared 510(K)
- K162508KerraCel Ag Gelling Fiber Silver DressingUCleared 510(K)
- K160695Talymed SuspensionUCleared 510(K)
- K160872PolyPlex Wound DressingUCleared 510(K)
- K161623Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mLUCleared 510(K)
- K152533Xonrid GelUCleared 510(K)
- K152970Dynarex Xeroform Petrolatum DressingUCleared 510(K)
- K161212Atteris Antimicrobial Skin ProtectantUCleared 510(K)
- K153565DONASORB SILVER WOUND DRESSINGUCleared 510(K)
- K161658Anexa Wound Flush, Sterile Water & Sterile Normal SalineUCleared 510(K)
- K153723ACTICOAT Surgical DressingUCleared 510(K)
- K160783ProcelleraUCleared 510(K)
- K161311USP 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 bottlesUCleared 510(K)
- K160379Exufiber Ag+UCleared 510(K)
- K161034Microcyn Plus Wound Care SolutionUCleared 510(K)
- K160022LUOFUCON Silicone Ag foam dressingUCleared 510(K)
- K153678PermeaDerm B, PermeaDerm CW, and PermeaDerm GloveUCleared 510(K)
- K153756Microlyte AgUCleared 510(K)
- K161289DURAFIBER AgUCleared 510(K)
- K160192Atteris Antimicrobial Skin & Wound CleanserUCleared 510(K)
- K150208Dakin's Skin and Wound CleanserUCleared 510(K)
- K153674Sorbact Foam Gentle Border, Sorbact SuperabsorbentUCleared 510(K)
- K160095Simple 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 23ozUCleared 510(K)
- K152519MTR550 (Tentative) Antimicrobial Silver Wound GelUCleared 510(K)
- K152544Agem Ag Mesh Dressing with SilverUCleared 510(K)
- K150914Dash-Topic Plus CreamUCleared 510(K)
- K153648Microcyn Plus Skin and Wound HydrogelUCleared 510(K)
- K143605Nutraseb Facial CreamUCleared 510(K)
- K151185AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX Wound Wash Skin and Wound Cleanser (OTC)UCleared 510(K)
- K152926AQUACEL Ag Surgical SP DressingUCleared 510(K)
- K150676L-Mesitran Dressing Family II- Soft and TulleUCleared 510(K)
- K151168Nexodyn AOS Wound Care SolutionUCleared 510(K)
- K150792Next Science Wound GelUCleared 510(K)
- K152945Alevicyn SG Antipruritic GelUCleared 510(K)
- K151186Stay Fresh Hydrocolloid dressingUCleared 510(K)
- K152055Ceramax Skin Barrier CreamUCleared 510(K)
- K150985Medihoney Wound GelUCleared 510(K)
- K150799Puracyn(R) Plus Duo-Care(TM) Antimicrobial Wound & Skin Hydrogel, Puracyn(R) Plus Antimicrobial Hydrogel Professional FormulaUCleared 510(K)
- K152923BD ChloraShield IV Dressing with CHG AntimicrobialUCleared 510(K)
- K142592CleanSmart Wound CleanserUCleared 510(K)
- K143444SynePure Wound CleanserUCleared 510(K)
- K143017Urgoclean Ag, Antibacterial Absorbent Wound Dressing with SilverUCleared 510(K)
- K142962PROTOCOL Incision DressingUCleared 510(K)
- K133279MEDIHONEY WOUND DRESSINGSUCleared 510(K)
- K143590Alevicyn SG Antipruritic GelUCleared 510(K)
- K141637SPB SKIN EMULSIONUCleared 510(K)
- K143335Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with Preservative (OTC)UCleared 510(K)
- K141863PURICORE WOUND HYDROGEL SPRAY DRESSINGUCleared 510(K)
- K140905DERMAFINEUCleared 510(K)
- K150256SILVERLON BURN CONTACT DRESSINGSUCleared 510(K)
- K143527IPM Wound Gel Bio, IPM Derm Gel BioUCleared 510(K)
- K141619LUOFUCON SILVER FOAM DRESSINGUCleared 510(K)
- K140954LUOFUCON SILVER PU ANTIBACTERIAL FOAM DRESSINGUCleared 510(K)
- K143058PuraDerm GelUCleared 510(K)
- K142775Neuwater TM (HydrocynTM aqua)UCleared 510(K)
- K141382BIOS KING BIOCELLULOSE FILMUCleared 510(K)
- K143151Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact Hydroactive B, Cutimed Siltec Sorbact)UCleared 510(K)
- K143124KA01 Chitosan Wound DressingUCleared 510(K)
- K133729WOUND DRESSING WITH MANUKA HONEYUCleared 510(K)
- K143001SILVERLON ISLAND WOUND DRESSING, SILVERLON WOUND PAD DRESSINGUCleared 510(K)
- K140389CHLORADERM ANTIMICROBIAL TRANSPARENT THIN FILM DRESSING, 2 3/8 X 2 3/4, 4 X 4 3/4UCleared 510(K)
- K141660NAWALUTION SKIN AND WOUND CLEANSERUCleared 510(K)
- K141603Ultra Silver DressingsUCleared 510(K)
- K141573SILVERLON ISLAND WOUND DRESSINGUCleared 510(K)
- K132326IONSIL GELUCleared 510(K)
- K141012HYDROCLEANSE WOUND CARE SOLUTIONUCleared 510(K)
- K132891HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVERUCleared 510(K)
- K140483ASAP OTC WOUND DRESSING GELUCleared 510(K)
- K131176ROSS RU SKIN DISCONTINUITIESUCleared 510(K)
- K133934MANUKA FOAM HC, MANUKA FOAM HC (WITH ACRYLIC ADHESIVE BORDER), MANUKA FOAM HC (WITH SILICONE ADHESIVE BORDER)UCleared 510(K)
- K122817SILVERLON ISLAND WOUND DRESSINGUCleared 510(K)
- K133542PURACYN PLUS SKIN AND WOUNDUCleared 510(K)
- K140147BCT ANTIMICROBIAL DRESSING & BCT SILVER BANDAGEUCleared 510(K)
- K132105PERCLOT TOPICALUCleared 510(K)
- K131848VASHE WOUND SOLUTION (4.0 OZ), (8.5 OZ & (16.0 OZ)UCleared 510(K)
- K133775EXSALT SD7 WOUND DRESSING WITH ADHESIVE BACKINGUCleared 510(K)
- K131796MANUKA FILL WOUND DRESSINGUCleared 510(K)
- K133764CHLORASHIELD IV DRESSING WITH CHG ANTIMICROBIALUCleared 510(K)
- K123193IPM WOUND GEL BIOUCleared 510(K)
- K130781L.A.M. IPM WOUND GEL, IPM DERM GELUCleared 510(K)
- K130040MEPITEL AGUCleared 510(K)
- K130670HYDROFERA BLUE PU BACTERIOSTATIC DRESSINGUCleared 510(K)
- K132329NIVATOPIC PLUSUCleared 510(K)
- K123678HYALMIX CREAMUCleared 510(K)
- K123910WOUNDWASH SALINE SPRAYUCleared 510(K)
- K130857PRONTOSAN WOUND GEL XUCleared 510(K)
- K123724DERMISEB CREAMUCleared 510(K)
- K123904PROTHELIALUCleared 510(K)
- K131542NEUTROPHASE(R) SKIN AND WOUND CLEANSER OTCUCleared 510(K)
- K130553ABSOCLEARUCleared 510(K)
- K130350PROCELLERAUCleared 510(K)
- K123481AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVEUCleared 510(K)
- K123394CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSINGUCleared 510(K)
- K122595HYDROPERMEATE TOPICAL EMULSION, ANSWER2SKIN SUNBURN RELIEF CREAM, ANSWER2SKIN FIRST AID CREAMUCleared 510(K)
- K123961SENTREX BIOSPONGE MPDUCleared 510(K)
- K123892MEPILEX TRANSFER AGUCleared 510(K)
- K123219URGOCLEAN ABSORBENT WOUND DRESSINGUCleared 510(K)
- K122634IODOFOAM IODOPHOR FOAM DRESSINGUCleared 510(K)
- K1236793M TEGADERM CHG CHLORHEXIDINE GLUCONATE I.V. PORT DRESSINGUCleared 510(K)
- K123072VASHE WOUND THERAPY SOLUTIONUCleared 510(K)
- K120181LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MMUCleared 510(K)
- K123071VASHE SKIN AND WOUND HYDROGELUCleared 510(K)
- K123113L.A.M. IMP WOUND GELUCleared 510(K)
- K113693NIXALL TM WOUND AND SKIN CAREUCleared 510(K)
- K121559HYLATOPICPLUS LOTIONUCleared 510(K)
- K121361CURALINE POLYURETHANE FOAM AWC DRESSINGUCleared 510(K)
- K120930CHG ANTIBACTERIAL FOAM DRESSING, CHG ANTIBACTERIAL PATCH, CHG ANTIBACTERIAL FOAM PATCH, CHG PATCH, CHG DRESSINGUCleared 510(K)
- K113836BENEHOLD CHG TRANSPARENT FILM DRESSING (10X12CM) (8.5X12CM) (6.5X7 CM)UCleared 510(K)
- K120730LOUTREX TOPICAL CREAMUCleared 510(K)
- K122297ENLUXTRA HUMIFIBER WOUND DRESSINGUCleared 510(K)
- K121819SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVERUCleared 510(K)
- K113820NEUTROPHASE ANTIMICROBIAL WOUND CLEANSERUCleared 510(K)
- K121275AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBERUCleared 510(K)
- K121134TL TRISEB CREAMUCleared 510(K)
- K121407OXYBAND WOUND DRESSINGUCleared 510(K)
- K121522POLYFIT ABSORBING ANTIMICROBIAL DRESSINGS (OTC)UCleared 510(K)
- K112191HEALEX BIOSPONGE WOUND DRESSINGUCleared 510(K)
- K111382CELVERUCleared 510(K)
- K121227MANUKA FILLUCleared 510(K)
- K120976MANUKA IGUCleared 510(K)
- K112549IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVERUCleared 510(K)
- K112666SALINE WOUND WASHUCleared 510(K)
- K113583CURAD ANTIBACTERIAL BANDAGEUCleared 510(K)
- K120828BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X4 INCHES, & 5X5 INCHESUCleared 510(K)
- K113807DEXERYL CREAMUCleared 510(K)
- K113774HPR PLUS EMOLLIENT FOAMUCleared 510(K)
- K113772HPR EMOLLIENT FOAMUCleared 510(K)
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- K103793DURAFIBER AGUCleared 510(K)
- K102943CORELEADER ALGI-FIBER WOUND DRESSING MODEL ADW 05050UCleared 510(K)
- K110744PRONTOSAN WOUND IRRIGATION SOLUTIONUCleared 510(K)
- K110727HYLATOPICPLUS CREAMUCleared 510(K)
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- K110042MANUKATEXUCleared 510(K)
- K110458SILVER ANTIMICROBIAL WOUND GELUCleared 510(K)
- K101793MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEYUCleared 510(K)
- K102945PEDIACYN ATOPIC DERMATITIS HYDROGELUCleared 510(K)
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- K103141LOW ADHERENT AFM AG DRESSINGSUCleared 510(K)
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- K101118ACTIVON TULLEUCleared 510(K)
- K100261PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLDUCleared 510(K)
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- K100029MEPILEX BORDER AG DRESSINGUCleared 510(K)
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- K102002TALYMEDUCleared 510(K)
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- K093159PR CREAMUCleared 510(K)
- K093320DRYODINE CADEXOMER-IODINE GELUCleared 510(K)
- K093351COLLAWOUND ARTUCleared 510(K)
- K100430URGOTUL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVERUCleared 510(K)
- K100429URGOCELL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVERUCleared 510(K)
- K092689MANUKAPLI WOUND DRESSINGUCleared 510(K)
- K100839BARIREPUCleared 510(K)
- K093697VASHE WOUND THERAPY SOLUTIONUCleared 510(K)
- K092348POLY FIT HIGH HYDRATING ANTIMICROBIAL DRESSINGSUCleared 510(K)
- K092351POLY FIT + ABSORBING AND HIGH ABSORBING ANTIMICROBIAL DRESSINGSUCleared 510(K)
- K093585MICROCYN SKIN AND WOUND HYDROGELUCleared 510(K)
- K093155VASHE WOUND CLEANSING SYSTEMUCleared 510(K)
- K100218BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CMUCleared 510(K)
- K093188AFM ULTRA AG DRESSINGSUCleared 510(K)
- K093544TROPAZONE CRUCleared 510(K)
- K092257JALOSKINUCleared 510(K)
- K091863AWBAT-S PLUS, AWBAT-D PLUS, AWBAT-M PLUSUCleared 510(K)
- K092878PRUTECT TOPICAL OINTMENT, MODELS 45 GRAM TUBE, 90 GRAM TUBEUCleared 510(K)
- K093349MEDLINE CURAD WOUND DRESSINGSUCleared 510(K)
- K090345MENDASIL TWG GEL ANTIMICROBIAL SKIN AND WOUND GELUCleared 510(K)
- K091034AQUACEL AG SURGICALUCleared 510(K)
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- K093051HYLATOPIC PLUS EMOLLIENT FOAMUCleared 510(K)
- K092826ASAP ANTIMICROBIAL SILVER WOUND DRESSING GELUCleared 510(K)
- K083133SILVERI: COFLEX AFD, COFLEX AFD FIRST AID, AFD PAD FOAM DRESSING, POWERFLEX AFD FOAM DRESSINGSUCleared 510(K)
- K090823THERAFORM BILAYERUCleared 510(K)
- K091354ACRYDERM SILVER ANTIMICROBIAL FOAM WOUND DRESSINGUCleared 510(K)
- K092297ELETONE CREAMUCleared 510(K)
- K090254SILVER IMPREGNATED HYDROFIBER DRESSING REINFORCED WITH NYLON (FLAT)UCleared 510(K)
- K092232MODIFICATION TO:VASHE WOUND CLEANSING SYSTEM, MODEL 9000-0014UCleared 510(K)
- K090337TROPAZONE LOTIONUCleared 510(K)
- K081246TT-102UCleared 510(K)
- K090791DAKIN'S ANTIMICROBIAL WOUND CLEANSER, MODEL 0.0125% TO 5%UCleared 510(K)
- K092086AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), MODEL A2026; 3 OZ (90G TUBE),MODEL A2027UCleared 510(K)
- K091719NEOSALUS LOTIONUCleared 510(K)
- K091013SILVER PU ANTIBACTERIAL FOAM DRESSING - NON ADHERENT AND ISLANDUCleared 510(K)
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- K090206OCULUS PURACYN ANTIMICROBIAL SKIN AND WOUND CLEANSERUCleared 510(K)
- K090725OCULUS MICROCYN WOUND GELUCleared 510(K)
- K090092SOCKIT! AND MCMERLIN DERMAL WOUND GELUCleared 510(K)
- K083659SILVER WOUND PADUCleared 510(K)
- K083007PROWICKUCleared 510(K)
- K090585NEOSALUS CREAMUCleared 510(K)
- K082333ASAP WOUND DRESSING GELUCleared 510(K)
- K090141PRONTOSAN ANTIMICROBIAL WOUND GELUCleared 510(K)
- K090453SILVER ALGINATE 11 WOUND DRESSINGUCleared 510(K)
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- K082296COPA AMDUCleared 510(K)
- K080949KERATEC WOUND DRESSINGSUCleared 510(K)
- K082089PRUMYX CREAMUCleared 510(K)
- K083355WOUND WASH SALINE, 210 ML, MODEL B8552, WOUND WASH SALINE, 90 ML, MODEL B8553UCleared 510(K)
- K083042WOUND FLUSH, STERILE WATER & NORMAL SALINEUCleared 510(K)
- K081977PROSIT WOUND TREATMENT DEVICEUCleared 510(K)
- K080503SILVER ALGINATE IV ANTIMICROBIAL WOUND DRESSINGUCleared 510(K)
- K082856CARAPASTE ORAL WOUND DRESSINGUCleared 510(K)
- K082330PRIMARY CARE SOLUTIONS, INC., STERILE WATER AND SALINE FOR IRRIGATIONUCleared 510(K)
- K081363NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING, SILVERCEL NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSINGUCleared 510(K)
- K082459ACRYDERM ABSORBENT OXYGEN DRESSINGUCleared 510(K)
- K073019SILVERMED ANTIMICROBIAL SILVER HYDROGELUCleared 510(K)
- K070309NEOSALUSUCleared 510(K)
- K073197SILVER ANTIMICROBIAL WOUND GELUCleared 510(K)
- K080497DERMA SCIENCES CALCIUM ALGINATE DRESSING WITH ANTIMICROBIAL SILVER (ALGICELL AG)UCleared 510(K)
- K081584DERMA SCIENCES OTC MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEYUCleared 510(K)
- K072876PRONTOSAN WOUND IRRIGATION SOLUTIONUCleared 510(K)
- K081274SURESKIN SILVER BANDAGESUCleared 510(K)
- K073213THERABOND ANTIMICROBIAL BARRIER SYSTEMSUCleared 510(K)
- K080620MODIFICATION TO 3M TEGADERM CHG DRESSINGUCleared 510(K)
- K070463REVERA WOUND CARE, MODEL MDW0060UCleared 510(K)
- K080383AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSINGUCleared 510(K)
- K071442SUPRASORB A +AGUCleared 510(K)
- K071552PURACOL PLUS AG COLLAGEN MICROSCAFFOLD WOUND DRESSINGUCleared 510(K)
- K080524CENTURION SORBAVIEW OTCUCleared 510(K)
- K080315DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEYUCleared 510(K)
- K073610ELTA ADVANCED WOUND WASHUCleared 510(K)
- K073547ANASEPT ANTIMICROBIAL SKIN AND WOUND CLEANSERS; ANASEPT ANTIMICROBIAL SKIN AND WOUND GELUCleared 510(K)
- K071483TETRIX CREAMUCleared 510(K)
- K080010NOCC HYDROPHILIC WOUND DRESSINGUCleared 510(K)
- K080471RADIO BIOAQUACAREUCleared 510(K)
- K071557COLLAWOUND HYDROGELUCleared 510(K)
- K072068BIOAQUACARE, MODEL C-10( VARIOUS SIZES) WITH AND WITHOUT GAUZE, BLISTER PACKAGED OR IN PLASTIC BAG CONTAINERSUCleared 510(K)
- K073251HYALOMATRIX PAUCleared 510(K)
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- K072378PROWICK ANTIMICROBIAL POSTOPERATIVE WOUND DRESSING, SHOULDER AND KNEE, MODELS AR-1625, AR-1626UCleared 510(K)
- K072956MEDIHONEY PRIMARY DRESSINGS WITH ACTIVE MANUKA HONEYUCleared 510(K)
- K071056NEUTROPHASE WOUND CLEANSERUCleared 510(K)
- K070685KENDALL ANTIMICROBIAL DRAIN DRESSING FOR OTC USE, MODEL 6662UCleared 510(K)
- K070653KENDALL KERLIX ANTIMICROBIAL SUPER SPONGE DRESSING FOR OTC USE, MODEL 6662UCleared 510(K)
- K071703ELTA SILVER ANTIMICROBIAL WOUND GEL DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGICUCleared 510(K)
- K063835ALLEVYN AG DRESSINGUCleared 510(K)
- K053613L-MESITRAN HYDRO, L-MESITRAN BORDER, L-MESITRAN NET, L-MESITRAN ACTIVEUCleared 510(K)
- K071354MEPILEX AG DRESSINGUCleared 510(K)
- K070581SILVER ALGINATE II WOUND DRESSINGUCleared 510(K)
- K063805SILCRYST SILVER ANTIMICROBIAL WOUND CREAM, MODEL A-00901UCleared 510(K)
- K063069SILVAKLENZ SKIN AND WOUND CLENSER SOLUTIONUCleared 510(K)
- K053095HONEY ALGINATE DRESSINGUCleared 510(K)
- K070333ACRYDERM SILVER ANTIMICROBIAL OTC WOUND GELUCleared 510(K)
- K063063SILVACIDE SKIN & WOUND MOISTURIZING SOLUTIONUCleared 510(K)
- K070557MP 719UCleared 510(K)
- K063059SORBACT WOUND DRESSINGUCleared 510(K)
- K063271AQUACEL HYDROFIBER DRESSING AND AQUACEL AG WITH HYDROFIBER SILVER IMPREGNATED ANTIMICROBIAL DRESSINGUCleared 510(K)
- K0634583M TEGADERM CHG DRESSINGUCleared 510(K)
- K984205SILVERLON ADHESIVE STRIPUCleared 510(K)
- K984204SILVERLON DIRECT PRESSURE WOUND CLOSURE STRIPUCleared 510(K)
- K060832RETRO-TECH DRESSINGUCleared 510(K)
- K063517HEALADEX-PUCleared 510(K)
- K061467EXSEPT WC WOUND CLEANSERUCleared 510(K)
- K062559URGOCELL AG ANTIMICROBIAL WOUND DRESSING WITH SILVERUCleared 510(K)
- K061554MEPILEX AG ABSORBENT SILICONE-COATED DRESSINGUCleared 510(K)
- K060272LOCOBASE WOUND AND SKIN EMULSIONUCleared 510(K)
- K061227HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVERUCleared 510(K)
- K062212SILVER SHIELD ANTIMICROBIAL SKIN AND WOUND GEL, MODEL 3015-SUCleared 510(K)
- K063173MODIFICATION TO SILVER ALGINATE II WOUND DRESSINGUCleared 510(K)
- K050158SINCLAIR SEBORRHEA EMULSIONUCleared 510(K)
- K053538MODIFICATION TO PHYTACARE ALGINATE HYDROGEL WOUND FILLERUCleared 510(K)
- K061232ACRYDERM SILVER ANTIMICROBIAL THIN FILM, MODEL 2006UCleared 510(K)
- K053590SILVERLON CA (CALCIUM ALGINATE)UCleared 510(K)
- K052536ALGICELL AGUCleared 510(K)
- K050842AGCEL WOUND DRESSING,AGCEL BURN DRESSINGUCleared 510(K)
- K061220URGOTUL AGUCleared 510(K)
- K061060TT101, MODELS TT 101-1,-2,-3,-4,-5,-6,-7,-8UCleared 510(K)
- K060901VASHE WOUND CLEANSING SYSTEMUCleared 510(K)
- K053476ALLWOUNDUCleared 510(K)
- K060237CMB ANTIMICROBIAL DRESSINGUCleared 510(K)
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- K060804COLLAGRAN-COLLAGEN WOUND DRESSING, COLLAGRANAG-COLLAGEN W/SILVER ANTIMICROBIAL WOUND DRESSINGUCleared 510(K)
- K052643EPICERAMUCleared 510(K)
- K051542TRIOSYN T40 ANTIMICROBIAL WOUND DRESSINGUCleared 510(K)
- K060113DERMACYN WOUND CAREUCleared 510(K)
- K050086BRENNEN MEDICAL SILVER GLUCAN WOUND DRESSINGUCleared 510(K)
- K052696COVACLEARAG COLLAGEN WITH SILVER ANTIMICROBIAL GEL SHEET DRESSINGUCleared 510(K)
- K043587SUCRALFATE AND CARAFATE PASTE KITSUCleared 510(K)
- K0532563M TEGADERM SILVER (AG) MESHUCleared 510(K)
- K050726SILVERSEAL SILVERAID WITH X-STATICUCleared 510(K)
- K051647FORTADERM ANTIMICROBIAL WOUND DRESSINGUCleared 510(K)
- K052720MEDLINE IODOFORM PACKING STRIPSUCleared 510(K)
- K042352BIODERM SCIENCES WOUND CREAMUCleared 510(K)
- K051445MILLIKEN SILVER WOUND DRESSINGSUCleared 510(K)
- K042084BIODERM SCIENCES WOUND HEALING SPRAYUCleared 510(K)
- K050649SILVERSEAL CONTACTING WOUND DRESSING WITH X-STATICUCleared 510(K)
- K042164SILVER ANTIMICROBIAL WOUND GAUZE (SPONGE)UCleared 510(K)
- K043296COLACTIVE AG COLLAGEN WITH SILVER ANTIMICROBIAL DRESSINGUCleared 510(K)
- K042729DERMACYN WOUND IRRIGATIONUCleared 510(K)
- K041059EPI-MAXUCleared 510(K)
- K041161MICROCYN WOUND CARE DRESSINGUCleared 510(K)
- K050030ACTICOAT MOISTURE CONTROL DRESSINGUCleared 510(K)
- K043063OXYBAND WOUND DRESSINGUCleared 510(K)
- K033900X-STATIC SILVERSEAL HYDROCOLLOID FILM AND ISLAND DRESSINGUCleared 510(K)
- K033732MEDTRADE PRODUCTS ANTISEPTIC BARRIER SILVER FOAM DRESSING, MODEL 09912450UCleared 510(K)
- K042400MUCOTROL CONCENTRATED ORAL GEL WAFERUCleared 510(K)
- K0408903M TEGADERM SILVERUCleared 510(K)
- K040518SELECT FABRICATORS, INC., AGMED TEX WOUND DRESSINGUCleared 510(K)
- K033523COLLAGEN-ORC ANTIMICROBIAL MATRIXUCleared 510(K)
- K033164ABRAM'S MULTI-DENSITY POLYURETHANE FOAM WOUND DRESSING SYSTEMUCleared 510(K)
- K032742SILVER FOAM WOUND DRESSINGUCleared 510(K)
- K041316ANTIMICROBIAL ALGINATE DRESSINGUCleared 510(K)
- K033587SILVERSEALUCleared 510(K)
- K041013SUILE OINTMENT WOUND DRESSINGUCleared 510(K)
- K040683BIODERM SCIENCES WOUND DRESSINGUCleared 510(K)
- K032983SENSITIVE SKIN ANTIBACTERIAL BANDAGESUCleared 510(K)
- K033869CONTREET FOAM CAVITY DRESSING WITH SILVER, MODEL 9628 (2X4 IN.)UCleared 510(K)
- K033453KENDALL ULTEC PRO AG+ HYDROCOLLOID DRESSINGUCleared 510(K)
- K032462CURAD SILVER ACTIVE GEL BANDAGEUCleared 510(K)
- K032463CURAD SILVER BANDAGEUCleared 510(K)
- K031307FERRIS POLYMEM SILVER WOUND DRESSINGUCleared 510(K)
- K022967SUILE WOUND DRESSINGUCleared 510(K)
- K024298ANTIMICROBIAL ALGINATE DRESSINGUCleared 510(K)
- K013936SILVERLEAF CONTACT WOUND DRESSINGUCleared 510(K)
- K022483ACTISORB SILVER 220 ANTIMICROBIAL BINDING DRESSINGUCleared 510(K)
- K022416CONTREET FOAM ADHESIVE/NON-ADHESIVEUCleared 510(K)
- K020318SCIVOLUTIONS VARIOUS ANTIBACTERIAL BANDAGESUCleared 510(K)
- K023612SILVERLON CONTACT WOUND DRESSINGUCleared 510(K)
- K023609SILVERLON ADHESIVE STRIPUCleared 510(K)
- K023138HYDROFERA BACTERIOSTATIC WOUND DRESSINGUCleared 510(K)
- K011618CALGITROL AG SILVER ALGINATE WOUND DRESSINGUCleared 510(K)
- K022670CARRAKLENZ AND ULTRAKLENZUCleared 510(K)
- K012816DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414UCleared 510(K)
- K013814ABSORBENT ANTIMICROBIAL WOUND DRESSINGUCleared 510(K)
- K020041IALUSET HYDROCOLLOIDUCleared 510(K)
- K014129PROMOGRAN MATRIX WOUND DRESSINGUCleared 510(K)
- K013462HYDROFERA BACTERIOSTATIC WOUND DRESSINGUCleared 510(K)
- K013056GELCLAIR CONCENTRATED ORAL GELUCleared 510(K)
- K003229BIOPATCH ANTIMICROBIAL DRESSINGUCleared 510(K)
- K012116ACRYDERM SILVER ANTIMICROBIAL PERFORATED WOUND DRESSINGUCleared 510(K)
- K011941EXCILON AMD ANTIMICROBIAL SPONGE MODEL #7088UCleared 510(K)
- K010951ISLAND WOUND DRESSING WITH MICROBANUCleared 510(K)
- K004028ARGLAES-AB ANTIMICROBIAL BARRIER POWDER DRESSINGUCleared 510(K)
- K010447MODIFICATION TO ACTICOAT FOAM DRESSINGUCleared 510(K)
- K002896ACTICOAT FOAM DRESSING, ALGISITE M CALCIUM ALGINATE DRESSINGUCleared 510(K)
- K002466ACTICOAT COMPOSITE DRESSINGUCleared 510(K)
- K002909ACRYDERM SILVER ANTIMICROBIAL STRANDS MODEL A-020103UCleared 510(K)
- K001519ACTICOAT 7 DRESSINGUCleared 510(K)
- K001023FREEDOM, MODEL 4660UCleared 510(K)
- K002599MODIFICATION TO ACRYDERM SILVER ANTIMICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044, 1045UCleared 510(K)
- K992221ACTICOAT PRIMARY ANTIMICROBIAL DRESSINGUCleared 510(K)
- K991818ACRYDERM SILVER ANTI-MICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044, 1045UCleared 510(K)
- K000051ACTICOAT FOAM DRESSINGUCleared 510(K)
- K993969SALJET SINGLE DOSE STERILE SALINE TOPICAL SOLUTIONUCleared 510(K)
- K992817ANTIBACTERIAL ADHESIVE BANDAGEUCleared 510(K)
- K984210SILVERLON WOUND PACKING STRIPSUCleared 510(K)
- K990810ARGLAES-AB ANTIMICROBIAL BARRIER FILM DRESSING & ISLAND DRESSINGUCleared 510(K)
- K992363SURESKIN II STANDARD, SURESKIN II BORDER, SURESKIN II THINUCleared 510(K)
- K991287SPYROGEL HYDROGEL WOUND AND BURN DRESSING SAUCleared 510(K)
- K990891DERMAPHYLYX HYDROCOLLOID WOUND DRESSING, HEALIAN HYDROCOLLOID WOUND DRESSINGUCleared 510(K)
- K990332DUMEX IODOFORM PACKING STRIPUCleared 510(K)
- K990861WOUND DRESSING/ABD PAD, MODEL #10810UCleared 510(K)
- K990086HELIDERM COLLAGEN WOUND DRESSINGS 0.5 GRAM AND 1.0 GRAMUCleared 510(K)
- K990042SILON DUAL-DRESSUCleared 510(K)
- K984597MODIFICATION OF CUTINOVA CAVITY DRESSINGUCleared 510(K)
- K984593MODIFICATION OF CUTINOVA THIN DRESSINGUCleared 510(K)
- K984599MODIFICATION OF CUTINOVA FOAM DRESSINGUCleared 510(K)
- K984595MODIFICATION OF CUTINOVA HYDRO DRESSINGUCleared 510(K)
- K984208SILVERLON ISLAND DRESSING, SILVERLON ISLAND PADUCleared 510(K)
- K982493COMPEED PSORIASIS DRESSINGUCleared 510(K)
- K983173BIATAIN FOAM ADHESIVE DRESSINGUCleared 510(K)
- K983163BIATAIN FOAM DRESSINGUCleared 510(K)
- K983249SURESKIN PLUS STANDARD, SURESKIN PLUS BORDER, SURESKIN PLUS THINUCleared 510(K)
- K981299SILVERLON CONTACT WOUND DRESSINGUCleared 510(K)
- K980777DUMEX PAK-ITS-ABSORBASALT COTTON GAUZE PACKINGUCleared 510(K)
- K97218520 ML NORMAL SALINE TOPICAL SOLUTION, 0.9% W/V SODIUM CHLORIDEUCleared 510(K)
- K974348ALGOPLAQUE FILM EXTRA THIN HYDROCOLLOID DRESSINGUCleared 510(K)
- K973807DUODERM HYDROACTIVE PASTEUCleared 510(K)
- K973688DUODERM CONTROL GEL FORMULA BORDER DRESSINGUCleared 510(K)
- K973689DUODERM HYDROACTIVE DRESSINGUCleared 510(K)
- K973632DUODERM CGF CONTROL GEL FORMULA DRESSINGUCleared 510(K)
- K973716DUODERM EXTRA THIN CGF DRESSINGUCleared 510(K)
- K973717COMBIDERM ACDUCleared 510(K)
- K973511KENDALL CURITY PETROLATUM GAUZEUCleared 510(K)
- K973507KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)UCleared 510(K)
- K973855IT HYDROCOLLOID WITH ZINCUCleared 510(K)
- K970566ARGLAES FILM DRESSINGUCleared 510(K)
- K971126HYDROCOLLOID WOUND DRESSINGSUCleared 510(K)
- K964701MITRAFLEX PIGMENTED WOUND DRESSINGUCleared 510(K)
- K963039SURESKIN STANDARD, BORDER, AND THINUCleared 510(K)
- K962590SIGNALDRESSUCleared 510(K)
- K960815DUPAD, DUPAD W/ABDOM. PAD, DUMEX ABDOM. PAD, COMBO DRESSING ROLL/COMBINE DRESSING ROLLUCleared 510(K)
- K955863ALLDRESS MULTI LAYERED WOUND DRESSINGUCleared 510(K)
- K952007ADHEROL SEPP APPLICATORUCleared 510(K)
- K936255CUSTOM CV PACKUCleared 510(K)
- K930549LAERDAL ALTERNATIVE POWER, 5-6 A,5-6 B,2000UCleared 510(K)
- K915477STERILIZATION BAG, POLYESTER/WRAPUCleared 510(K)
- K905040ALGINATE FIBERUCleared 510(K)
- K905438NORMLGEL PROTECTIVE WOUND GELUCleared 510(K)
- K910080KALTOSTAT WOUND PACKINGUCleared 510(K)
- K910059KALTOSTAT WOUND DRESSINGUCleared 510(K)
- K905519MONTROSE DRESSING APPLICATORSUCleared 510(K)
- P870069BIOBRANE (R) II BLUE LABEL PRODUCTUPMA Approval
- K905314ALGODERM ALGINATE WOUND DRESSINGUCleared 510(K)
- K901853MODIFIED LABELING FOR BIOCLUSIVE* TRANS FILM DRESSUCleared 510(K)
- K904852DUODERM DRESSINGS, CGF DRESSINGS, PASTE FULL THICKUCleared 510(K)
- K904488KALTOSTAT WOUND DRESSINGUCleared 510(K)
- K901378TENSOPLUS LITEUCleared 510(K)
- K902345CARRINGTON WOUND DRESSINGUCleared 510(K)
- K901109WOUND TREATMENT KITUCleared 510(K)
- K901369GREEN LABEL BIOBRANE II AND RED LABEL BIOBRANE IIUCleared 510(K)
- K897142MESALT STERILE DRESSINGUCleared 510(K)
- K900516WATER JEL STERILE GEL-SOAKED BURN DRESSINGUCleared 510(K)
- P870069BIOBRANEUPMA Approval
- K897156HYDRASORB(TM)UCleared 510(K)
- K895654SORBEX(TM) SOFT SPONGEUCleared 510(K)
- K893123ADHESIVE BANDAGES & PADS FOR MINOR CUTS/SCRAPESUCleared 510(K)
- K896421TRANSPARENT FILM I.V. SITE/WOUND DRESSINGUCleared 510(K)
- K896702WOUND DRESSINGUCleared 510(K)
- K895817HERMAL WOUND CARE KITUCleared 510(K)
- K894226SILASTIC SOFT SHEETINGUCleared 510(K)
- K894541CARRINGTON DERMAL WOUND GELUCleared 510(K)
- K896110BIOBRANE(R) IIUCleared 510(K)
- K8958452018 ARTERIAL/VENOUS PRESSURE DRESSINGUCleared 510(K)
- K890107GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KITUCleared 510(K)
- P870069BIOBRANE(R) IIUPMA Approval
- K895207BIOCLUSIVE* TRANSPARENT FILM DRESSING - NEW CLAIMUCleared 510(K)
- K894996EXUSORB(TM) GRANULESUCleared 510(K)
- K892851ACTISORB* PLUS ACTIVATED CHARCOAL DRESS W/SILVERUCleared 510(K)
- K883619MEDICATED COVERING COATED W/1.0% HYDRO ADHES. GELUCleared 510(K)
- K883566MEDICATED COVERING COATED W/.5% HYDRO ADHESIVE GELUCleared 510(K)
- K894254HYPAFIX DRESSING RETENTION SHEETUCleared 510(K)
- K891097DAMOR CREAM SATURATED DRESSINGUCleared 510(K)
- K8948982ND SKIN NON-STICK MOIST BURN PADSUCleared 510(K)
- K894347KALTOCARB WOUND DRESSINGUCleared 510(K)
- K891870INTRASITE* GEL (3) YEAR SHELF LIFEUCleared 510(K)
- K892837STERIL-DERM TRANSPARENT WOUND DRESSINGUCleared 510(K)
- K885096PHYNE-VUUCleared 510(K)
- K892868KALTOSTAT WOUND PACKINGUCleared 510(K)
- K892364KALTOSTAT(TM) WOUND DRESSINGUCleared 510(K)
- K885279CUTINOVA(R) PLUS ON VASCULAR STASIS ULCERSUCleared 510(K)
- K891288TEGASORB(TM) ULCER DRESSING, #90-XXXUCleared 510(K)
- K892360WATER JEL STERILE GEL-SOAKED BURN DRESSINGUCleared 510(K)
- K891998BANDAGE, MUSLIN, COMPRESSED, CAMOUFLAGED, 37X37X52UCleared 510(K)
- K891459STERILE BURNNET PRE-CUT (VARIOUS SIZES)UCleared 510(K)
- K891189WEDGE PRESSURE DRESSINGUCleared 510(K)
- K891133VARIOUSLY SIZED STERILE COTTON WOUND DRESSINGSUCleared 510(K)
- K882558AREOLA/NIPPLE DRESSINGUCleared 510(K)
- K890603BEAM TECH WOUND DRESSING*UCleared 510(K)
- K892527DUODERM* TRANSPARENT HYDROCOLLOID DRESSING-MODIFYUCleared 510(K)
- K892232ACTIDERM*-OPAQUEUCleared 510(K)
- K891696DUODERM* EXTRA THIN FLEXIBLE HYDROCOLLOID DRESSINGUCleared 510(K)
- K884791PERME-AID TRANSPARENT DRESSING, #11XXUCleared 510(K)
- K890354TEGAPORE WOUND CONTACT MATERIAL, PRODUCT #563XUCleared 510(K)
- K890940MODIFIED LABELING FOR POLYDERM WBC(TM)UCleared 510(K)
- K885325FRASTEC CONFORMANT DRESSING, VARIOUS SIZESUCleared 510(K)
- K890545NU-DERM HYDROCOLLOID DRESSINGUCleared 510(K)
- K883391POLYMER ADHESIVE BANDAGEUCleared 510(K)
- K885321WATER JEL STERILE GEL-SOAKED BURN DRESSINGUCleared 510(K)
- K890748ALLEVYN TRACHEOSTOMY DRESSINGUCleared 510(K)
- K884422POLYGLUCOSE POWDERUCleared 510(K)
- K883849REPLICARE (ADDITIONAL CLAIMS)UCleared 510(K)
- K884440TECNOL VARIABLE TENSION BANDAGEUCleared 510(K)
- K883224UNNA BOOT DRESSING W/CALAMINEUCleared 510(K)
- K884397PHARMASEAL STERILE WOUND CARE DRESSINGUCleared 510(K)
- K881426PAN-PRA AID SELF-ADHE. COLLO. COATED BANDAGEUCleared 510(K)
- K882590VIADERMUCleared 510(K)
- K882567SKINCOTEUCleared 510(K)
- K883588COMPEED ATHLETIC DRESSINGUCleared 510(K)
- K881936OPER-FILM-ADHESIVE MEMBRANEUCleared 510(K)
- K881731AD-HEAL(TM) WOUND DRESSINGUCleared 510(K)
- K882696DERMICEL, MONTGOMERY STRAPUCleared 510(K)
- K881854SORBSAN TOPICAL WOUND DRESSINGUCleared 510(K)
- K8819883M WOUND CONTACT MATERIAL, PRODUCT #563XUCleared 510(K)
- K881039HYDROCOLLOID DRESSING FOR PSORIASISUCleared 510(K)
- K881302DUODERM(R) HYDROACTIVE(R) PASTEUCleared 510(K)
- K880153POLYDERM A+B(TM)UCleared 510(K)
- K875253BFGOODRICH BIOTHANE NON-ADHERENT DRESSINGUCleared 510(K)
- K881050DUODERM(R) CGFUCleared 510(K)
- K880788NON ADHERENT PADUCleared 510(K)
- K872298TEGASORB ULCER DRESSING #90-XXXUCleared 510(K)
- K880330FERRIS HYDROPHILIC DRESSINGUCleared 510(K)
- K881048AIRSTRIP* WATERPROOF FIRST AID DRESS/POST-OPERA.UCleared 510(K)
- K880206POLYDERM WBC (TM), WATERPROOF BREATHABLE COVERUCleared 510(K)
- K874554ENVICLUSIVE (TM)UCleared 510(K)
- K872573PHARMACLUSIVE (TM)UCleared 510(K)
- K880299REPLICAREUCleared 510(K)
- K874480MODIFIED MANUFACTURING PROCESS FOR OMIDERM(TM)UCleared 510(K)
- K872926DERMATOLOGICAL PATCHUCleared 510(K)
- K864841WATER-JEL(R) BURN DRESSINGUCleared 510(K)
- K874478DYNAFILMUCleared 510(K)
- K874470MWI 400 WOUND DRESSINGUCleared 510(K)
- K874161MODIFIED USE OF TRIANGLE BANDAGE STERILEUCleared 510(K)
- K874219S3 MEDICATED GAUZEUCleared 510(K)
- K873669COMFEEL ULCUS ULCER CARE SYSTEMUCleared 510(K)
- K874291EPI-LOCK T.M. PRIMADERMUCleared 510(K)
- K871327D.R.P. THREE STEP WOUND DRESSINGUCleared 510(K)
- K873277MITRAFLEX(TM) WOUND DRESSINGUCleared 510(K)
- K872988TRANSIGEN EXUDATE CONTROLLED WOUND DRESSINGUCleared 510(K)
- K872875STRETCH GAUZE BANDAGESUCleared 510(K)
- K872982JOHNSON & JOHNSON ABSORBENT OCCLUSIVE DRESSINGUCleared 510(K)
- K871675FERRIS TRANSPARENT WOUND DRESSING W/HYDROCOLLOIDUCleared 510(K)
- K872624INTRASITE INTERACTIVE HYDROCOLLOID WOUND DRESSINGUCleared 510(K)
- K864913CUTINOVA(R) PLUS FOAM GELFILMUCleared 510(K)
- K872069KONTOUR ULTRA SOFT SPONGE #SS144.50UCleared 510(K)
- K871458SURVIVAL KIT, INDIVIDUAL, TROP, TACTICAL AIR CREWUCleared 510(K)
- K872100BIOFILM TRANSORBENT ULCER AND WOUND DRESSINGUCleared 510(K)
- K872101BIOFILM TRANS. POUCH ULCER & WOUND DRESSINGUCleared 510(K)
- K872099BIOFILM TRANS. ISLAND, ISLAND ULCER & WOUND DRESS.UCleared 510(K)
- K872165ELASTO-GEL OCCLUSIVE DRESSINGUCleared 510(K)
- K871770AMERICAN PHARMASEAL WOUND DRESSINGUCleared 510(K)
- K871166ALLEVYN HYDROPHILIC POLYURETHANE DRESSINGUCleared 510(K)
- K871255MODIFIED HERCON ANTISEPTIC TRANSPARENT DRESSINGUCleared 510(K)
- K871495BANDAGES CATALOG NUMBER: 101 TO 220UCleared 510(K)
- K870430PAD, PETROLATUM & BISMUTH TRIBROMOPHENATE IMPREG.UCleared 510(K)
- K870743HERCON ANTI. TRANS. DRESSING AS A WOUND DRESSINGUCleared 510(K)
- K870352RUBYCELL(TM) SYNTHETIC ISLAND DRESSINGUCleared 510(K)
- K870239DRESSING, BURN, 24 BY 36 INCHESUCleared 510(K)
- K870241COMPRESS AND BANDAGE, VARIOUS SIZESUCleared 510(K)
- K870184BANDAGE, GAUZE, FINE MESH, 3 BY 8 INCHESUCleared 510(K)
- K870185BANDAGE, GAUZE (NONABSOR. GAUZE FOR EXTERNAL USE)UCleared 510(K)
- K865089FERRIS DYNADERM PLUSUCleared 510(K)
- K864688ARNOLD-KING PRESSURE DRESSINGUCleared 510(K)
- K863580DERMATEC TRANSPARENT FILM DRESSINGUCleared 510(K)
- K863930VISCOPASTE ZINC PASTE BANDAGEUCleared 510(K)
- K863578DERMATEC ZONE TRANSPARENT DRESSINGUCleared 510(K)
- K864011EXU-DRY BURN/TRAUMA DRESSING, VARIOUS SIZESUCleared 510(K)
- K864084LYOFOAM C ODOR-ABSORBING DRESSINGUCleared 510(K)
- K863389UNITED WOUND COVERING, PACKAGE OF 5UCleared 510(K)
- K862803CHESEBROUGH POND'S HYDROCOLLOID DRESSINGUCleared 510(K)
- K863390HYDROCOLLOID DRESSINGS - STERILEUCleared 510(K)
- K863379DERMATEC BURN PADSUCleared 510(K)
- K862935WOUND MANAGER(TM) - STERILEUCleared 510(K)
- K862572HOLLISTER WOUND CARE BARRIERUCleared 510(K)
- K860892CLINAGEL (ABSORBENT GEL)UCleared 510(K)
- K862163JOHNSON & JOHNSON PETROLATUM GAUZE NON ADHER DRESSUCleared 510(K)
- K861384NON-ADHERING DRESSING WITH POVIDONE-IODINEUCleared 510(K)
- K861972DERMISTRIPUCleared 510(K)
- K860085LYOFOAM WOUND DRESSINGSUCleared 510(K)
- K861024BARD ABSORPTION DRESSINGUCleared 510(K)
- K860486ACTISORB ACTIVATED CHARCOAL DRESSINGUCleared 510(K)
- K854740PRIMADERMUCleared 510(K)
- K854464IV SECUREMENT DEVICESUCleared 510(K)
- K854463ADHESIVE TAPE, WOUND CARE, WOUND DRESSINGUCleared 510(K)
- K854850FALKON STRETCH-STERILEUCleared 510(K)
- K851885OMIDERM WOUND & BURN DRESSINGUCleared 510(K)
- K853844DUODERM HYDROACTIVE DRESSING W/BORDER STERILEUCleared 510(K)
- K852750TEGADERM PLUS TRANSPARENT DRESSING #952XUCleared 510(K)
- K852545BAND-AID BRAND ADHESIVE BANDAGESUCleared 510(K)
- K852614ATRAUM WOUND DRESSINGUCleared 510(K)
- K853334NON-ADHERA ADHESIVE PAD 3X4UCleared 510(K)
- K852211OPSITE WOUND DRESSINGUCleared 510(K)
- K851383BLISTERFILM TRANSPARENT DRESSINGUCleared 510(K)
- K851382CHESEBROUGH-POND'S SEQUENTIAL WOUND DRESSINGUCleared 510(K)
- K850889BARD OCCLUSIVE WOUND DRESSINGUCleared 510(K)
- K850147CUTINOVA GELFILM SYNTHETIC WOUND DRESSING, STERILEUCleared 510(K)
- K852091ALBA DRY BURN PADUCleared 510(K)
- K850535MITRATHANE DRESSINGUCleared 510(K)
- K850451J & J ULCER DRESSINGUCleared 510(K)
- K843206COOK COUNTY HOSPITAL DRESSING CHANGE SETUCleared 510(K)
- K850819GELIPERM ABSORBIND GRANULATED GELUCleared 510(K)
- K850282HYPAFIX POST OPERATIVE DRESSINGUCleared 510(K)
- K850126OIL EMULSION NON-ADHERING DRESSINGUCleared 510(K)
- K850904ALBA DRY BURN DRESSINGUCleared 510(K)
- K850076WOUND DRESSING MODEL ZB-6UCleared 510(K)
- K850241ALBA HEALTH CARE NON-ADHERING DRESSINGUCleared 510(K)
- K843200SITE STRIPUCleared 510(K)
- K844095WET DRESSING WATER-STERILEUCleared 510(K)
- K844096WET DRESSING SALINE-STERILEUCleared 510(K)
- K843139ISOLATE ADHESIVE BANDAGE FOR MOIST WOUNDUCleared 510(K)
- K843140ISOLATE ADHESIVE BANDAGE FOR DRY WOUNDUCleared 510(K)
- K842967AQUAPHOR R GAUZEUCleared 510(K)
- K840438COMFEEL ULCUS SHEETUCleared 510(K)
- K842186ACU-DERM TRANSPARENT WOUND DRESSINGUCleared 510(K)
- K841287DUODERM FLEXIBLE HYDROACTIVE DRESSINGSUCleared 510(K)
- K842064ACU-DERM TRANSPARENT IV DRESSINGUCleared 510(K)
- K832699HYDRON WOUND DRESSING FAST SEAT KITUCleared 510(K)
- K840745STERILE ABSORBENT GAUZE BURN & SOUNDUCleared 510(K)
- K822306BIO-BAND BANDAGESUCleared 510(K)
- K833730NON ADHERENT BANDAGE/SHEETUCleared 510(K)
- K833075WET DRESSING KITUCleared 510(K)
- K834532STERILE WET DRESSING PACKUCleared 510(K)
- K832407DECUBITUS CARE ABSORBENT DRESSINGUCleared 510(K)
- K831710BARD ABSORPTION DRESSINGUCleared 510(K)
- K833729ELASTIC BREATHABLE OVER-WRAP BANDAGEUCleared 510(K)
- K833733NON - ADHERENT BANDAGEUCleared 510(K)
- K833638DERMATEX STERILE FINGER BANDAGEUCleared 510(K)
- K831204MULTIPLEUCleared 510(K)
- K831454LASTOBAND ADHESIVE BANDAGESUCleared 510(K)
- K831657ALKA FIRST AID KITUCleared 510(K)
- K831283TRIANGLE BANDAGE STERILEUCleared 510(K)
- K823225GELIPERM GRANULESUCleared 510(K)
- K822073GELIPERM DRYUCleared 510(K)
- K822058GELIPERM TRANSPARENT GEL-FILM DRESSINGUCleared 510(K)
- K831611UNI-THANEUCleared 510(K)
- K830050MOLNLYCKE MEPORE STERILE SELF-ADHESIVEUCleared 510(K)
- K830375FIRST AID BAGS #1,2,3UCleared 510(K)
- K830825YIELD NON-ADHERENT DRESSINGUCleared 510(K)
- K830373FIRST AID KITUCleared 510(K)
- K830374RESCUE PACKUCleared 510(K)
- K830708DUO DERM FLEX HYDROACTIVE DRESSINGS &UCleared 510(K)
- K830640BOO-BOO STRIPUCleared 510(K)
- K822990CONVERTORS PRIMARY WOUND DRESSING IIUCleared 510(K)
- K830593ENSURE DRESSINGUCleared 510(K)
- K823852CHESEBROUGH-POND'S MULTILAYER ELASTICUCleared 510(K)
- K830089BURN DRESSINGUCleared 510(K)
- K830166MOLNLYCKE ETE STERILE NON-ADHERENT DRESSUCleared 510(K)
- K830051MOLNLYCKE MESALT STERILE DRESSINGUCleared 510(K)
- K822467PERFILM MEMBRANE DRESSINGUCleared 510(K)
- K822424CURITY TRANSPARENT FILM DRESSINGUCleared 510(K)
- K822080ADHESIVE WOUND COVER FILMUCleared 510(K)
- K821655DUODERM HYDROACTIVE GRANULESUCleared 510(K)
- K821656DUODERM FLEXIBLE HYDROACTIVE DRESSINGSUCleared 510(K)
- K820635PVP GEL DRESSINGUCleared 510(K)
- K821258SELOPORUCleared 510(K)
- K821246MELOLINUCleared 510(K)
- K820620BIOBRANE R II BRANDUCleared 510(K)
- K822047INTERSORB DRY BURN VEST & PANTSUCleared 510(K)
- K820470UNIFLEXUCleared 510(K)
- K820413AEGIS NON-ADHERENT DRESSINGUCleared 510(K)
- K820198DERMA-AIDUCleared 510(K)
- K820139SOF-ROL CAST PADDINGUCleared 510(K)
- K820105COMBINE PAD OR ABDUCleared 510(K)
- K820056TELFA STRIPSUCleared 510(K)
- K820096VAG PACKINGUCleared 510(K)
- K820097SHEET WADDING CAST PADDINGUCleared 510(K)
- K820098ROLLER GAUZEUCleared 510(K)
- K813535XEROFORM DRESSINGUCleared 510(K)
- K813365MULTIPLE BANDAGE OR DRESSINGUCleared 510(K)
- K812678TEGADERM TRANSPARENT DRESSINGUCleared 510(K)
- K813419COMFORT CUSHION DRY BURN PAD IIIUCleared 510(K)
- K813308DOUBLE SEAL TUBEGUAZE STERILE BANDAGEUCleared 510(K)
- K812073DESERET CATHETER DRESSINGUCleared 510(K)
- K812501OPRAFLEXUCleared 510(K)
- K810902IP-758 BURN WOUND DRESSINGUCleared 510(K)
- K811814TRIANGULAR BANDAGEUCleared 510(K)
- K810050VECAFIX*UCleared 510(K)
- K803115DRESSING CHANGE FOR G TUBEUCleared 510(K)
- K803119LARGE WOUND DRESSING KITUCleared 510(K)
- K803117CUSTOM DRESSING TRAY WET TO DRYUCleared 510(K)
- K803114HYPERALIMENTATION DRESSING CHANGE TRAYUCleared 510(K)
- K803118SIMPLE DRESSING TRAY #82028UCleared 510(K)
- K802793LOMATUELL OINTMENT DRESSINGUCleared 510(K)
- K802791ZINC PASTE BANDAGEUCleared 510(K)
- K802017DRESSING CHANGE SET CAT.#910-930UCleared 510(K)
- K801996GUAZE BANDAGES CAT.#101-169UCleared 510(K)
- K802021PEDIBAND CAT.#195-197UCleared 510(K)
- K802006TRIANGULAR BANDAGE CAT.#191UCleared 510(K)
- K802013FIRST AID BANDAGE CAT.#198 OR 199UCleared 510(K)
- K801840SURGICAL BANDAGES/SUNLEEP DXUCleared 510(K)
- K801635BIOBRANE BRAND TEMPORARY WOUND-DRESSINGUCleared 510(K)
- K800953FIXOMULL STERILEUCleared 510(K)
- K791573JELONET PARAFFIN GAUZE DRESSINGSUCleared 510(K)
- K791369AIRSTRIP THEATRE WARD DRESSINGUCleared 510(K)
- K780795GAUZE SPONGESUCleared 510(K)
- K780764NON-STERILE FOLDED GAUZEUCleared 510(K)
- K780549NON-STICK PADSUCleared 510(K)
- K780394GAUZE FLUFFUCleared 510(K)
- K780336URINE SAMPLE KITUCleared 510(K)
- K780222I.V. START KITUCleared 510(K)
- K761093BANDAGEUCleared 510(K)
- K760250BANDAGE, TRIANGULAR NO. 8068UCleared 510(K)
- GELGauze/Sponge, Internal, With Drug/Biologic, Animal Source MaterialUProduct Code
- GERGauze, External (With Drug/Biologic/Animal Source Material)UProduct Code
- HMNSuture, Nonabsorable, Ophthalmic3Product Code
- HMOSuture, Absorbable, Ophthalmic3Product Code
- KGMSilicone, Liquid, Injectable3Product Code
- KGNDressing, Wound, CollagenUProduct Code
- LCJExpander, Skin, InflatableUProduct Code
- LFLInstrument, Ultrasonic SurgicalUProduct Code
- LMHImplant, Dermal, For Aesthetic Use3Product Code
- LMIImplant, Collagen For Non-Aesthetic Use3Product Code
- LRQTracheostomy And Nasal Suctioning Kit1Product Code
- LRRFirst Aid Kit With DrugNProduct Code
- LXULaser For Wound Healing3Product Code
- MAWMarker, Suture IdentificationUProduct Code
- MDDDevice, Dermal Replacement3Product Code
- MGPDressing, Wound And Burn, OcclusiveUProduct Code
- MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or BiologicUProduct Code
- MGRDressing, Wound And Burn, Interactive3Product Code
- MQZProsthesis, NailUProduct Code
- MRDSizer, Mammary, Breast Implant VolumeUProduct Code
- MSADressing, Wound And Burn, Occlusive, HeatedUProduct Code
- NLQScalpel, Ultrasonic, ReprocessedUProduct Code
- NQKMaggots, MedicalUProduct Code
- NRNLeeches, MedicinalUProduct Code
- NSSElectronic Media, NauseaNProduct Code
- NZFStatic Electricity-Emitting Device, Cosmetic UseNProduct Code
- OCECultured Epithelial AutograftFProduct Code
- ODSWound Covering (Composite Cultured Skin)FProduct Code
- OEEDiagnostic Low Electric Field3Product Code
- OJIBurn Kit With DrugNProduct Code
- ONVElectrical Impedance Spectrometer3Product Code
- OYDOptical Diagnostic Device For Melanoma Detection3Product Code
- PFCCultured Human Cell Skin Dressing3Product Code
- PHUIntra-Abdominal Pressure Monitoring DeviceUProduct Code
- PKYImplant, Dermal, For Aesthetic Use In The Hands3Product Code
- PUVLymph Node Location System During Sentinel Biopsy Procedure3Product Code
- PZCAblation System, High Intensity Focus Ultrasound (Hifu), Soft TissueNProduct Code
- QOJApparatus, Suction, Operating-Room, Wall Vacuum Powered (Export Only)NProduct Code
- QQFSkin Microneedling Manual/Automated Device (Export Only)NProduct Code
- QVSBreast Implant Suction Retrieval Device2Product Code
- QVXSkin Patch For Treatment Of Hyperhidrosis2Product Code
- PLJTissue Adhesive Internal Use3Product Code
- QSXHemostatic Wound Dressing With Thrombin Or Other BiologicsUProduct Code
- QSYHemostatic Wound Dressing Without Thrombin Or Other BiologicsUProduct Code
- QSZAbsorbable Synthetic Wound DressingUProduct Code
- QGMFocused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation2Product Code
- QZSSoftware-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer2Product Code
- SABTable Mounted Miniaturized Electromechanical Surgical System2Product Code
- SAQElectromechanical System For Open Microsurgery2Product Code
- SAWFluorescence Imaging For Breast Cancer Detection3Product Code
- QMLAnal Fistula Closure Device2Product Code
- SAHMagnetic Compression Anastomosis System2Product Code
- QYKSemi-Automated Autologous Skin Graft Harvesting And Application Device2Product Code
- SCVModular Electromechanical Surgical System2Product Code
- SDDElectromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field2Product Code
- Submissions with No Product CodeMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Biatain Silicone Ag
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K191536
- 510(k) Type
- Traditional
- Applicant
- Coloplast A/S
- Country
- Denmark
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/21/2020
- Days to Decision
- 256 days
- Submission Type
- Summary