510(k) Report

Devices descending from K990810

28 later devices reach Arglaes-AB Antimicrobial Barrier Film Dressing & Island Dressing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121819Surgiclear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and SilverCovalontechnologies, Inc.20123—
+1K112549IV Clear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and SilverCovalontechnologies, Inc.20120—
+1K033900X-Static Silverseal Hydrocolloid Film and Island DressingNoble Fiber Technologies20052—
+1K041268Silversite or CalgitrolAdri20042—
+1K033453Kendall Ultec Pro AG+ Hydrocolloid DressingTyco Healthcare20040—
+1K024054Xylos Xcell Antimicrobial DressingXylos Corporation20037—
+1K013525Contreet-H Antimicrobial Hydrocolloid Dressing, Models 9610 (4 X 4 (10 CM X 10CM), 9613…Coloplast Corp.200213—
+1K004028Arglaes-AB Antimicrobial Barrier Powder DressingMaersk Medical, Ltd.20010—
+2K173072Algidex Ag Silver Alginate Wound DressingDeroyal Industries, Inc.20180—
+2K163529ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG…Avery Dennison Corporation20171—
+2K140389Chloraderm Antimicrobial Transparent Thin Film Dressing, 2 3/8 X 2 3/4, 4 X 4 3/4Entrotech Life Sciences, Inc.20140—
+2K102212D-Stat Dry Silver; D-Stat Dry Clear Silver; D-Stat Dry Wrap Silver; Thrombix SilverVascular Solutions, Inc.20110—
+2K093351Collawound ArtCollamatrix, Inc.20100—
+2K072378Prowick Antimicrobial Postoperative Wound Dressing, Shoulder and Knee, Models AR-1625…Arthrex, Inc.20071—
+2K061220Urgotul AGLaboratoires Urgo20067—
+2K050032Euromed Sureskin Iii with Silver Wound DressingsEuromed, Inc.20062—
+2K051647Fortaderm Antimicrobial Wound DressingOrganogenesis, Inc.20053—
+3K251582Redermax Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.20261—
+3K251866Tegaderm Post-Op Transparent Antimicrobial DressingSolventum US, LLC20250—
+3K151186Stay Fresh Hydrocolloid dressingSarasota Medical Products, Inc.20150—
+3K100429Urgocell AG, Antimicrobial Wound Dressing with SilverLaboratoires Urgo20100—
+3K100430Urgotul AG, Antimicrobial Wound Dressing with SilverLaboratoires Urgo20102—
+3K083007ProwickArthrex, Inc.20090—
+3K081274Sureskin Silver BandagesEuromed, Inc.20081—
+3K062559Urgocell AG Antimicrobial Wound Dressing with SilverLaboratoires Urgo20076—
+4K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.20260—
+4K242758Atrauman® AgHartmann USA, Inc.20240—
+4K130040Mepitel AGMolnlycke Health Care20140—