510(k) Report

Devices descending from K910944

267 later devices reach Medifil through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213092Cellusheet, CellufilHuman Biosciences, Inc.20211—
+1K120250Fibrillar Collagen Wound DressingCollafirm, LLC20130—
+1K110318ExcellagenTissue Repair Company20110—
+1K072113Integra Flowable Wound Matrix, Model FWD301Integra Lifesciences Corp.200751
+1K061474Collawound DressingCollamatrix Co., Inc.20063—
+1K040314HealicollEncoll Corp.20040—
+1K030774Stimulen CollagenSouthwest Technologies, Inc.2004291
+1K030921Collagen Topical Wound DressingCollagen Matrix, Inc.200328—
+1K993948Sis Wound Dressing IICook Biotech, Inc.2000235—
+1K963228Repliderm Wound DressingOrphan Medical, Inc.19960—
+2K253140CollOvine™ Wound PowderOvigenex, LLC20260—
+2K250329GeniPhys Collymer Self-Assembling ScaffoldGeniphys, Inc.20250—
+2K232758Comatryx OTCStrukmyer Medical, LLC20230—
+2K213341Fibrillar Collagen Wound DressingCollagen Matrix, Inc.20220—
+2K134037PremviaBiotime, Inc.20140—
+2K102946Coreleader Colla-Pad Model CS 03030Coreleader Biotech Co., Ltd.20110—
+2K092096Endoform Dermal TemplateMesynthes, Ltd.2010193
+2K090894Collawound Wound DressingCollamatrix Co., Inc.20092—
+2K080868Aongen Collagen MatrixAeon Astron Europe B.V.20091—
+2K081724Hydrolyzed Collagen with 10% Chondroitin Sulfate (Psgag, Polysulfated Glycosaminoglycan)…Applied Nutritionals20080—
+2K061494Dermadapt Wound DressingPegasus Biologics, Inc.200626—
+2K060888Acell Powder Wound DressingAcell, Inc.20065—
+2K040403Collagen Wound Dressing - OralCollagen Matrix, Inc.200410—
+2K040558Modification to: Collagen Topical Wound DressingCollagen Matrix, Inc.200413—
+2K040211Modification to: Collagen Topical Wound DressingCollagen Matrix, Inc.200414—
+2K023778DressskinTei Biosciences, Inc.200331—
+2K022854Acell Ubm Hydrated Wound DressingAcell, Inc.20020—
+2K021637Acell Ubm Lyophilized Wound DressingAcell, Inc.200245—
+2K022127Avagen Wound DressingIntegra Lifesciences Corp.200228—
+2K021792Bilayer Matrix Wound DressingIntegra Lifesciences Corp.2002531
+2K020732SS MatrixCook Biotech, Inc.20025—
+2K001738Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.2000173—
+3K260669Endoform Dermal TemplateAroa Biosurgery, Ltd.20260—
+3K241904DermiSphere Dermal TemplateFesariustherapeutics, Inc.20250—
+3K243071Bovine Dermis Collagen Dermal MatrixCollagen Matrix, Inc.20240—
+3K220498NovoGen Wound MatrixNovabone Products, LLC20231—
+3K213573PELNAC Wound MatrixGunze Limited20220—
+3K210128INTEGRA Wound Matrix (Macro-Channels)Integra LifeSciences Corporation20210—
+3K200502Myriad ParticlesAroa Biosurgery, Ltd.20214—
+3K191992PELNAC Bilayer Wound MatrixGunze Limited20200—
+3K172593XCelliStem Wound PowderStemsys20181—
+3K173223ologen Collagen MatrixAeon Astron Europe B.V.20180—
+3K171231Endoform Topical MatrixAroa Biosurgery20173—
+3K162348ABCcolla Collagen MatrixAcro Biomedical Co., Ltd.20171—
+3K153754MicroMatrixAcell, Inc.20160—
+3K142879BTM Wound DressingPolynovo Biomaterials Pty, Ltd.20155—
+3K140820Xenomem Wound MatrixViscus Biologics, LLC20150—
+3K142712Dental Collagen Wound Dressing (Nova Tape and NovaPlug)Novabone Products, LLC20150—
+3K140456Bio-Connekt Wound MatrixMLM Biologics, Inc.20140—
+3K132397Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc.201410—
+3K130557Neuragen 3DIntegra LifeSciences Corporation20141—
+3K132343Marigen Wound DressingKerecis Limited20135—
+3K131286Primatrix Dermal Repair ScaffoldTei Biosciences, Inc.20135—
+3K122115Collagen Dental Wound DressingsCollagen Matrix, Inc.20125—
+3K113104Integra Wound Matrix (Thin)Integra LifeSciences Corporation20120—
+3K110388Collacare DentalInnocoll Pharmaceuticals, Ltd.20116—
+3K100261Primatrix AG Antimicrobial Dermal Dermal Repair ScaffoldTei Biosciences, Inc.201063
+3K101546Endoform Dental TemplateMesynthes, Ltd.20100—
+3K092926Acell Matristem Wound SheetAcell, Inc.200914—
+3K090823Theraform BilayerSewon Cellontech Co., Ltd.20090—
+3K082079Regen Collagen Scaffold (CS)Regen Biologics, Inc.20082—
+3K081635Integra Meshed Bilayer Wound MatrixIntegra Lifesciences Corp.200810—
+3K073251Hyalomatrix PAFidia Advanced Biopolymers Srl200721
+3K071425Unite BiomatrixPegasus Biologics, Inc.200725—
+3K070557MP 719Marine Polymer Technologies, Inc.20072—
+3K061892Propatch Soft Tissue Repair MatrixCryolife, Inc.200617—
+3K061746Collaguard, Model Fcia,Fcib,Fcic,and FcidInnocoll Pharmaceuticals200612—
+3K061407Primatrix Dermal Repair ScaffoldTei Biosciences, Inc.200627—
+3K052830SportmeshArtimplant AB200644—
+3K043388Pegasus Biologics Orthadapt Surgical MeshPegasus Biologics, Inc.200549—
+3K040621Acell Ubm Surgical MeshAcell, Inc.20045—
+3K033671Gore Bioabsorbable MeshW. L. Gore & Associates, Inc.200339—
+3K031969Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.200391—
+3K031188OrthomendTei Biosciences, Inc.200336—
+3K021056PermacolTissue Science Laboratories, Plc200251—
+3K020049Fortaflex Surgical MeshOrganogenesis, Inc.2002102—
+4K261311HyalomatrixAnika Therapeutics, Inc.20260—
+4K260711Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc…Berkeley Advanced Biomaterials20260—
+4K233378ABCcolla® Collagen ADM ScaffoldAcro Biomedical Co., Ltd.20240—
+4K232204ReyaGel (RG03 - MTP gel 3mL)Fettech20240—
+4K231325Corplex P / Theracor P / Allacor PStimlabs, LLC20243—
+4K213498PELNAC Meshed Bilayer Wound MatrixGunze Limited20220—
+4K210135PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing3M Healthcare Business Group20221—
+4K200413SymphonyAroa Biosurgery, Ltd.20202—
+4K190528MariGen Wound ExtraKerecis Limited20193—
+4K173143Phasix ST MeshC.R. Bard, Inc.20181—
+4K173544Phoenix Wound MatrixNanofiber Solutions, Inc.20180—
+4K172318Endoform Silver Dermal TemplateAroa Biosurgery20170—
+4K172140NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm)…Polynovo Biomaterials Pty, Ltd.20174—
+4K170364Collagen Meniscus Implant XLIvy Sports Medicine, LLC20171—
+4K170300Restrata Wound MatrixAcera Surgical, Inc.201741
+4K163217GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.20175—
+4K163457NeuraGen 3D Nerve Guide MatrixIntegra LifeSciences Corporation20170—
+4K161067Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen…Engineered Tissue Solutions, LLC20163—
+4K153364Kerecis SecureMeshKerecis Limited20160—
+4K152600Collagen Dental Wound DressingsCollagen Matrix, Inc.201621
+4K153690PriMatrix Dermal Repair ScaffoldTei Biosciences, Inc.201644
+4K152609GORE SYNECOR BiomaterialW. L. Gore & Associates, Inc.20153—
+4K141084Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor MatrixAcell, Inc.20153—
+4K133290Collacare DentalInnocoll Pharmaceuticals20141—