FDA 510(k) Applications for Medical Device Product Code "FRO"
(Dressing, Wound, Drug)

FDA 510(k) Number Applicant Device Name Decision Date
K143058 3-D Matrix, Inc. PuraDerm Gel 02/13/2015
K193085 3-D Matrix, Inc. PuraDERM Gel 05/11/2020
K200835 3M Company 3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad 09/04/2020
K123679 3M COMPANY 3M TEGADERM CHG CHLORHEXIDINE GLUCONATE I.V. PORT DRESSING 02/28/2013
K171908 3M Company 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing 07/11/2017
K153410 3M COMPANY 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing 05/15/2017
K063458 3M COMPANY 3M TEGADERM CHG DRESSING 04/05/2007
K110457 3M COMPANY 3M TEGADERM MATRIX DRESSING 12/07/2011
K040890 3M COMPANY 3M TEGADERM SILVER 11/02/2004
K053256 3M COMPANY 3M TEGADERM SILVER (AG) MESH 12/16/2005
K080620 3M COMPANY-3M HEALTH CARE MODIFICATION TO 3M TEGADERM CHG DRESSING 05/19/2008
K170754 3M Company, 3M Health Care 3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced Securement Dressing 11/21/2017
K210135 3M Health Care Business Group PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing 02/24/2022
K100591 ABIGO MEDICAL AB SORBACT 01/24/2011
K153674 ABIGO Medical AB Sorbact Foam Gentle Border, Sorbact Superabsorbent 07/01/2016
K063059 ABIGO MEDICAL AB SORBACT WOUND DRESSING 04/19/2007
K171225 ABIGO Medical AB Sorbact Wound Dressing-Ribbon Gauze 08/21/2017
K151185 ABL Medical, LLC AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX Wound Wash Skin and Wound Cleanser (OTC) 02/05/2016
K140483 ABL MEDICAL, LLC ASAP OTC WOUND DRESSING GEL 05/20/2014
K120730 ACELLA PHARMACEUTICALS, LLC LOUTREX TOPICAL CREAM 09/06/2012
K223725 Acera Surgical, Inc. Restrata« MiniMatrix 05/18/2023
K082459 ACRYMED, INC. ACRYDERM ABSORBENT OXYGEN DRESSING 09/19/2008
K083103 ACRYMED, INC. ACRYDERM ANTIMICROBIAL SILVER GEL WOUND DRESSING MODEL #B 02/26/2009
K991818 ACRYMED, INC. ACRYDERM SILVER ANTI-MICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044, 1045 04/17/2000
K091354 ACRYMED, INC. ACRYDERM SILVER ANTIMICROBIAL FOAM WOUND DRESSING 10/21/2009
K070333 ACRYMED, INC. ACRYDERM SILVER ANTIMICROBIAL OTC WOUND GEL 07/10/2007
K012116 ACRYMED, INC. ACRYDERM SILVER ANTIMICROBIAL PERFORATED WOUND DRESSING 09/12/2001
K002909 ACRYMED, INC. ACRYDERM SILVER ANTIMICROBIAL STRANDS MODEL A-020103 10/13/2000
K061232 ACRYMED, INC. ACRYDERM SILVER ANTIMICROBIAL THIN FILM, MODEL 2006 10/06/2006
K002599 ACRYMED, INC. MODIFICATION TO ACRYDERM SILVER ANTIMICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044, 1045 09/21/2000
K011618 ADRI CALGITROL AG SILVER ALGINATE WOUND DRESSING 11/15/2002
K222909 Advamedica Inc. Axiostat Gauze 04/07/2023
K212766 Advamedica Inc. Maxiocel Chitosan Wound Dressing 08/24/2023
K223310 Advanced Medical Solutions Limited Antimicrobial Silicone PHMB Foam Wound Dressing 04/05/2023
K063173 ADVANCED MEDICAL SOLUTIONS LIMITED MODIFICATION TO SILVER ALGINATE II WOUND DRESSING 11/03/2006
K081363 ADVANCED MEDICAL SOLUTIONS LIMITED NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING, SILVERCEL NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING 09/24/2008
K090453 ADVANCED MEDICAL SOLUTIONS LIMITED SILVER ALGINATE 11 WOUND DRESSING 02/26/2009
K070581 ADVANCED MEDICAL SOLUTIONS LIMITED SILVER ALGINATE II WOUND DRESSING 07/13/2007
K080503 ADVANCED MEDICAL SOLUTIONS LIMITED SILVER ALGINATE IV ANTIMICROBIAL WOUND DRESSING 11/12/2008
K110458 ADVANCED MEDICAL SOLUTIONS LIMITED SILVER ANTIMICROBIAL WOUND GEL 03/14/2011
K073197 ADVANCED MEDICAL SOLUTIONS LIMITED SILVER ANTIMICROBIAL WOUND GEL 08/28/2008
K091013 ADVANCED MEDICAL SOLUTIONS LIMITED SILVER PU ANTIBACTERIAL FOAM DRESSING - NON ADHERENT AND ISLAND 07/30/2009
K024298 ADVANCED MEDICAL SOLUTIONS LTD. ANTIMICROBIAL ALGINATE DRESSING 06/30/2003
K041316 ADVANCED MEDICAL SOLUTIONS LTD. ANTIMICROBIAL ALGINATE DRESSING 08/05/2004
K210974 Advanced Medical Solutions Ltd. High Performance Antimicrobial Gelling Fiber with Silver 05/12/2021
K163062 Advanced Medical Solutions Ltd. PHMB Antimicrobial Foam Wound Dressing 07/25/2017
K181197 Advanced Medical Solutions Ltd. PHMB Foam Wound Dressing 08/03/2018
K190819 Advanced Medical Solutions Ltd. Silicone PHMB Foam Wound Dressing 07/25/2019
K032742 ADVANCED MEDICAL SOLUTIONS LTD. SILVER FOAM WOUND DRESSING 08/16/2004
K183645 Advanced Medical Solutions Ltd. Silver High Performance Dressing 05/29/2019
K180634 Advanced Medical Solutions Ltd. Surgical Silver Post Operative Dressing 08/07/2018
K101114 Advancis Medical ADVANCIS ACTIVON TUBE 07/26/2011
K061467 ALCAVIS INTERNATIONAL, INC. EXSEPT WC WOUND CLEANSER 02/15/2007
K171041 Alliqua BioMedical, Inc SilverSeal 08/22/2017
K221570 Allmed Medical Products Co., Ltd. Antibacterial bandage 09/29/2023
K092826 AMERICAN BIOTECH LABS ASAP ANTIMICROBIAL SILVER WOUND DRESSING GEL 11/12/2009
K082333 AMERICAN BIOTECH LABS ASAP WOUND DRESSING GEL 04/02/2009
K092086 AMERX HEALTH CARE CORP. AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), MODEL A2026; 3 OZ (90G TUBE),MODEL A2027 07/30/2009
K181423 Amsino International Inc. AMSure Sterile Water, and Sterile Normal Saline for Wound Flush 09/07/2018
K201138 Amsino Medical Inc. AMSure« Single Use Saline Topical Solution 04/14/2021
K073547 ANACAPA TECHNOLOGIES, INC. ANASEPT ANTIMICROBIAL SKIN AND WOUND CLEANSERS; ANASEPT ANTIMICROBIAL SKIN AND WOUND GEL 04/23/2008
K062212 ANACAPA TECHNOLOGIES, INC. SILVER SHIELD ANTIMICROBIAL SKIN AND WOUND GEL, MODEL 3015-S 11/21/2006
K083133 ANDOVER HEALTHCARE INC. SILVERI: COFLEX AFD, COFLEX AFD FIRST AID, AFD PAD FOAM DRESSING, POWERFLEX AFD FOAM DRESSINGS 10/30/2009
K161658 ANEXA BIOMEDICAL, INC. Anexa Wound Flush, Sterile Water & Sterile Normal Saline 09/14/2016
K172486 Anexa Biomedical, Inc. 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 chlo 09/21/2017
K151168 APR Applied Pharma Research SA Nexodyn AOS Wound Care Solution 12/22/2015
K180305 Aquilabs US LLC Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC) 04/13/2018
K182681 Arch Therapeutics, Inc. AC5 Topical Gel 12/14/2018
K190129 Arch Therapeutics, Inc. AC5 Topical Gel 03/11/2020
K073019 ARGENTIS BIOMEDICAL INCORPORATED SILVERMED ANTIMICROBIAL SILVER HYDROGEL 09/16/2008
K023609 ARGENTUM INTERNATIONAL LLC. SILVERLON ADHESIVE STRIP 01/17/2003
K984205 ARGENTUM INTERNATIONAL LLC. SILVERLON ADHESIVE STRIP 03/19/2007
K023612 ARGENTUM INTERNATIONAL LLC. SILVERLON CONTACT WOUND DRESSING 01/24/2003
K981299 ARGENTUM INTERNATIONAL LLC. SILVERLON CONTACT WOUND DRESSING 09/25/1998
K984204 ARGENTUM INTERNATIONAL LLC. SILVERLON DIRECT PRESSURE WOUND CLOSURE STRIP 03/19/2007
K984208 ARGENTUM INTERNATIONAL LLC. SILVERLON ISLAND DRESSING, SILVERLON ISLAND PAD 02/22/1999
K984210 ARGENTUM INTERNATIONAL LLC. SILVERLON WOUND PACKING STRIPS 09/24/1999
K150256 ARGENTUM MEDICAL SILVERLON BURN CONTACT DRESSINGS 04/30/2015
K141573 ARGENTUM MEDICAL SILVERLON ISLAND WOUND DRESSING 08/28/2014
K143001 ARGENTUM MEDICAL SILVERLON ISLAND WOUND DRESSING, SILVERLON WOUND PAD DRESSING 11/07/2014
K221218 Argentum Medical, Inc. Silverlon Wound Contact, Burn Contact Dressings 10/26/2022
K180570 Argentum Medical, LLC Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing) 01/14/2019
K190343 Argentum Medical, LLC Silverlon Wound Contact, Burn Contact Dressings 07/18/2019
K053590 ARGENTUM MEDICAL, LLC. SILVERLON CA (CALCIUM ALGINATE) 10/06/2006
K122817 ARGENTUM MEDICAL, LLC. SILVERLON ISLAND WOUND DRESSING 05/01/2014
K172318 Aroa Biosurgery Endoform Silver Dermal Template 11/17/2017
K083007 ARTHREX, INC. PROWICK 04/08/2009
K072378 ARTHREX, INC. PROWICK ANTIMICROBIAL POSTOPERATIVE WOUND DRESSING, SHOULDER AND KNEE, MODELS AR-1625, AR-1626 11/09/2007
K183662 Ascent Consumer Products, Inc. Saline Wound Wash, SteriCleanse(TM) 09/12/2019
K082910 ASO LLC CVS SILVER BANDAGES, WALGREENS SILVER BANDAGES, XYZ SILVER BANDAGES 06/17/2009
K053476 AT SQUARED, LLC ALLWOUND 06/26/2006
K200641 ATTWILL Medical Solutions HaloGUARD Protective Disc with CHG 09/03/2020
K091863 AUBREY, INC. AWBAT-S PLUS, AWBAT-D PLUS, AWBAT-M PLUS 01/21/2010
K152923 AVERY DENNISON BELGIE BVBA BD ChloraShield IV Dressing with CHG Antimicrobial 11/05/2015
K170407 Avery Dennison Belgie BVBA BD ChloraShield IV Dressing with CHG Antimicrobial 07/17/2017
K113836 AVERY DENNISON BELGIE, BVBA BENEHOLD CHG TRANSPARENT FILM DRESSING (10X12CM) (8.5X12CM) (6.5X7 CM) 09/24/2012
K133764 AVERY DENNISON BELGIE, BVBA CHLORASHIELD IV DRESSING WITH CHG ANTIMICROBIAL 03/13/2014
K163529 AVERY DENNISON CORPORATION ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG (10cm x 25cm) 03/29/2017
K161623 B. Braun Medical Inc. Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL 11/10/2016
K090141 B. BRAUN MEDICAL, INC. PRONTOSAN ANTIMICROBIAL WOUND GEL 03/17/2009
K101882 B. BRAUN MEDICAL, INC. PRONTOSAN ANTIMICROBIAL WOUND GEL 11/03/2010
K163430 B. Braun Medical, Inc. Prontosan Wound Gel 05/23/2017
K130857 B. BRAUN MEDICAL, INC. PRONTOSAN WOUND GEL X 10/08/2013
K072876 B. BRAUN MEDICAL, INC. PRONTOSAN WOUND IRRIGATION SOLUTION 06/19/2008
K110744 B. BRAUN MEDICAL, INC. PRONTOSAN WOUND IRRIGATION SOLUTION 04/06/2011
K122297 BASF VENTURE CAPITAL AMERICA INC. ENLUXTRA HUMIFIBER WOUND DRESSING 08/28/2012
K190342 Bausch Health Americas Incorporated BIAFINE Topical Cream 10/18/2019
K210751 BC3 Technologies Inc S.E.A.L. Hemostatic Wound Spray 02/02/2023
K032462 BEIERSDORF AG CURAD SILVER ACTIVE GEL BANDAGE 02/10/2004
K032463 BEIERSDORF AG CURAD SILVER BANDAGE 02/10/2004
K984597 BEIERSDORF-JOBT, INC. MODIFICATION OF CUTINOVA CAVITY DRESSING 03/01/1999
K984599 BEIERSDORF-JOBT, INC. MODIFICATION OF CUTINOVA FOAM DRESSING 03/01/1999
K984595 BEIERSDORF-JOBT, INC. MODIFICATION OF CUTINOVA HYDRO DRESSING 03/01/1999
K984593 BEIERSDORF-JOBT, INC. MODIFICATION OF CUTINOVA THIN DRESSING 03/01/1999
K042400 BELCHER PHARMACEUTICALS, INC. MUCOTROL CONCENTRATED ORAL GEL WAFER 11/24/2004
K140147 BIO-MEDICAL CARBON TECHNOLOGY CO., LTD. BCT ANTIMICROBIAL DRESSING & BCT SILVER BANDAGE 04/22/2014
K072068 BIOARTIFICIAL GEL TECHNOLOGIES (BAGTECH) INC BIOAQUACARE, MODEL C-10( VARIOUS SIZES) WITH AND WITHOUT GAUZE, BLISTER PACKAGED OR IN PLASTIC BAG CONTAINERS 12/21/2007
K080471 BIOARTIFICIAL GEL TECHNOLOGIES (BAGTECH) INC RADIO BIOAQUACARE 03/05/2008
K042352 BIODERM SCIENCES, INC. BIODERM SCIENCES WOUND CREAM 10/17/2005
K040683 BIODERM SCIENCES, INC. BIODERM SCIENCES WOUND DRESSING 06/04/2004
K042084 BIODERM SCIENCES, INC. BIODERM SCIENCES WOUND HEALING SPRAY 06/15/2005
K100613 BIOMED LABORATORIES, INC BIOMED WOUND CLEANSER 01/05/2011
K210949 Bionova Medical Inc. Foundation Dermal Regeneration Scaffold (DRS) Solo 08/11/2022
K112191 BIONOVA MEDICAL, INC HEALEX BIOSPONGE WOUND DRESSING 06/05/2012
K123961 BIONOVA MEDICAL, INC SENTREX BIOSPONGE MPD 04/05/2013
K131176 BIOTD, S.A. ROSS RU SKIN DISCONTINUITIES 05/12/2014
K162017 BIOTD, S.A. Ross Ru Wound Dressing Gel 04/20/2017
K141637 BIOTD, S.A. SPB SKIN EMULSION 06/03/2015
K083355 BLAIREX LABORATORIES, INC. WOUND WASH SALINE, 210 ML, MODEL B8552, WOUND WASH SALINE, 90 ML, MODEL B8553 12/29/2008
K050086 BRENNEN MEDICAL, INC. BRENNEN MEDICAL SILVER GLUCAN WOUND DRESSING 02/17/2006
K143151 BSN MEDICAL GMBH Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact Hydroactive B, Cutimed Siltec Sorbact) 01/26/2015
K153138 BU POLYSCIENCES EQUIPMENT & TRADING, LLC Cerdak Basic 06/23/2017
K101118 CALIDAD SOLUTIONS, INC. ACTIVON TULLE 12/15/2010
K103106 CARE FUSION 213 LLC CHLORASHIELD TM ANTIMICROBIAL DRESSING 03/30/2011
K022670 CARRINGTON LABORATORIES, INC. CARRAKLENZ AND ULTRAKLENZ 10/17/2002
K111382 CELLULOSE CONCEPTS LLC CELVER 05/31/2012
K090791 CENTURY PHARMACEUTICALS, INC. DAKIN'S ANTIMICROBIAL WOUND CLEANSER, MODEL 0.0125% TO 5% 08/07/2009
K150208 CENTURY PHARMACEUTICALS, INC. Dakin's Skin and Wound Cleanser 07/21/2016
K052643 CERAGENIX CORPORATION EPICERAM 04/11/2006
K073213 CHOICE THERAPEUTICS THERABOND ANTIMICROBIAL BARRIER SYSTEMS 05/28/2008
K181428 Clyra Medical Technologies Inc. Clyra Wound Irrigation Solution 09/20/2019
K071557 COLLAMATRIX CO., INC. COLLAWOUND HYDROGEL 02/08/2008
K090894 COLLAMATRIX CO., INC. COLLAWOUND WOUND DRESSING 06/25/2009
K093351 COLLAMATRIX, INC COLLAWOUND ART 06/16/2010
K093320 COLLEGIUM PHARMACEUTICAL INCORPORATED DRYODINE CADEXOMER-IODINE GEL 06/18/2010
K093051 COLLEGIUM PHARMACEUTICAL INCORPORATED HYLATOPIC PLUS EMOLLIENT FOAM 12/07/2009
K100218 COLOPLAST A/S BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM 02/17/2010
K191536 Coloplast A/S Biatain Silicone Ag 02/21/2020
K120828 COLOPLAST A/S BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X4 INCHES, & 5X5 INCHES 04/05/2012
K022416 COLOPLAST CORP. CONTREET FOAM ADHESIVE/NON-ADHESIVE 02/03/2003
K033869 COLOPLAST CORP. CONTREET FOAM CAVITY DRESSING WITH SILVER, MODEL 9628 (2X4 IN.) 05/17/2004
K090345 CONSEAL INTERNATIONAL, INC. MENDASIL TWG GEL ANTIMICROBIAL SKIN AND WOUND GEL 01/07/2010
K091034 CONVATEC AQUACEL AG SURGICAL 12/16/2009
K121275 CONVATEC INC AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBER 07/25/2012
K123481 CONVATEC INC AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE 06/06/2013
K152926 CONVATEC LIMITED AQUACEL Ag Surgical SP Dressing 01/21/2016
K173675 ConvaTec Limited AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber 07/20/2018
K013814 CONVATEC, A DIVISION OF E.R. SQUIBB & SONS ABSORBENT ANTIMICROBIAL WOUND DRESSING 06/21/2002
K080383 CONVATEC, A DIVISION OF E.R. SQUIBB & SONS, L.L.C. AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING 05/02/2008
K090254 CONVATEC, A DIVISION OF E.R. SQUIBB & SONS, L.L.C. SILVER IMPREGNATED HYDROFIBER DRESSING REINFORCED WITH NYLON (FLAT) 09/04/2009
K063271 CONVATEC, A DIVISION OF E.R. SQUIBB & SONS, LLC. AQUACEL HYDROFIBER DRESSING AND AQUACEL AG WITH HYDROFIBER SILVER IMPREGNATED ANTIMICROBIAL DRESSING 04/16/2007
K141382 CORELEADER BIOTECH CO., LTD. BIOS KING BIOCELLULOSE FILM 02/10/2015
K102943 CORELEADER BIOTECH CO., LTD. CORELEADER ALGI-FIBER WOUND DRESSING MODEL ADW 05050 04/12/2011
K102942 CORELEADER BIOTECH CO., LTD. CORELEADER ALGIPLASTER MODEL AP 050501 06/22/2011
K111578 CORELEADER BIOTECH CO., LTD. CORELEADER COLLA-ALGI FIBER MODEL CAW 09/23/2011
K123394 CORELEADER BIOTECH CO., LTD. CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSING 06/06/2013
K071483 CORIA LABORATORIES, LTD TETRIX CREAM 04/04/2008
K060804 COVALON TECHNOLOGIES LTD. COLLAGRAN-COLLAGEN WOUND DRESSING, COLLAGRANAG-COLLAGEN W/SILVER ANTIMICROBIAL WOUND DRESSING 04/18/2006
K052696 COVALON TECHNOLOGIES LTD. COVACLEARAG COLLAGEN WITH SILVER ANTIMICROBIAL GEL SHEET DRESSING 02/03/2006
K043296 COVALON TECHNOLOGIES, INC. COLACTIVE AG COLLAGEN WITH SILVER ANTIMICROBIAL DRESSING 06/06/2005
K112549 COVALON TECHNOLOGIES, INC. IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER 05/04/2012
K121819 COVALON TECHNOLOGIES, INC. SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER 08/13/2012
K082296 COVIDIEN LP, FORMERLY REGISTERED AS TYCO HEALTHCAR COPA AMD 02/26/2009
K213652 Cresilon, Inc. Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG) 06/28/2023
K132105 CRYOLIFE, INC. PERCLOT TOPICAL 04/03/2014
K121361 CURALINE INC CURALINE POLYURETHANE FOAM AWC DRESSING 11/30/2012
K053538 CURAPHARM, INC. MODIFICATION TO PHYTACARE ALGINATE HYDROGEL WOUND FILLER 10/10/2006
K052536 DERMA SCIENCES CANADA, INC. ALGICELL AG 09/13/2006
K080497 DERMA SCIENCES CANADA, INC. DERMA SCIENCES CALCIUM ALGINATE DRESSING WITH ANTIMICROBIAL SILVER (ALGICELL AG) 06/27/2008
K053095 DERMA SCIENCES CANADA, INC. HONEY ALGINATE DRESSING 07/12/2007
K080315 DERMA SCIENCES, INC. DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY 04/23/2008
K081584 DERMA SCIENCES, INC. DERMA SCIENCES OTC MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY 06/19/2008
K101793 DERMA SCIENCES, INC. MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEY 02/22/2011
K110546 DERMA SCIENCES, INC. MEDIHONEY HYDROGEL SHEET DRESSINGS WITH ACTIVE LEPTOSPERMUM HONEY 07/27/2011
K072956 DERMA SCIENCES, INC. MEDIHONEY PRIMARY DRESSINGS WITH ACTIVE MANUKA HONEY 11/07/2007
K133279 DERMA SCIENCES, INC. MEDIHONEY WOUND DRESSINGS 06/25/2015
K150985 DERMA SCIENCES, INC. Medihoney Wound Gel 11/19/2015
K041059 DERMAGENICS, INC. EPI-MAX 05/17/2005
K122595 DERMAL LIFE LLC HYDROPERMEATE TOPICAL EMULSION, ANSWER2SKIN SUNBURN RELIEF CREAM, ANSWER2SKIN FIRST AID CREAM 05/01/2013
K142962 DEROYAL INDUSTRIES PROTOCOL Incision Dressing 07/23/2015
K173072 DeRoyal Industries, Inc. Algidex Ag Silver Alginate Wound Dressing 04/04/2018
K033164 DR. LEN'S MEDICAL PRODUCTS LLC ABRAM'S MULTI-DENSITY POLYURETHANE FOAM WOUND DRESSING SYSTEM 09/07/2004
K960815 DUMEX MEDICAL SURGICAL PRODUCTS, LTD. DUPAD, DUPAD W/ABDOM. PAD, DUMEX ABDOM. PAD, COMBO DRESSING ROLL/COMBINE DRESSING ROLL 04/29/1996
K012816 DYNAREX CORP. DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414 10/17/2002
K152970 DYNAREX CORPORATION Dynarex Xeroform Petrolatum Dressing 10/03/2016
K140389 ENTROTECH LIFE SCIENCES INC. CHLORADERM ANTIMICROBIAL TRANSPARENT THIN FILM DRESSING, 2 3/8 X 2 3/4, 4 X 4 3/4 11/07/2014
K200767 EnzySurge Ltd. SilverStream Gel 10/08/2020
K093227 ENZYSURGE, LTD. SILVERSTREAM AND DERMASEPT 12/10/2009
K050032 EUROMED, INC. EUROMED SURESKIN III WITH SILVER WOUND DRESSINGS 05/17/2006
K081274 EUROMED, INC. SURESKIN SILVER BANDAGES 05/28/2008
K083870 EXCITON TECHNOLOGIES INC. EXSALT SD7 WOUND DRESSING 07/30/2009
K103067 EXCITON TECHNOLOGIES INC. EXSALT SD7 WOUND DRESSING 05/20/2011
K133775 EXCITON TECHNOLOGIES INC. EXSALT SD7 WOUND DRESSING WITH ADHESIVE BACKING 03/26/2014
K113564 EXCITON TECHNOLOGIES INC. EXSALT T7 WOUND DRESSING 12/15/2011
K100580 EXCITON TECHNOLOGIES INC. EXSALT WOUND DRESSING 10/12/2010
K162508 Exciton Technologies Inc. KerraCel Ag Gelling Fiber Silver Dressing 02/13/2017
K182680 Exciton Technologies, Inc. KerraContact Ag Perf Advanced Perforated Silver Wound Dressing 12/06/2018
K170911 EXELTIS USA Dermatology, LLC NEOCERA Advanced Barrier Cream 08/22/2017
K060272 FERNDALE LABORATORIES, INC. LOCOBASE WOUND AND SKIN EMULSION 01/12/2007
K092297 FERNDALE PHARMA GROUP, INC. ELETONE CREAM 10/09/2009
K031307 FERRIS MFG. CORP. FERRIS POLYMEM SILVER WOUND DRESSING 10/22/2003
K073251 FIDIA ADVANCED BIOPOLYMERS SRL HYALOMATRIX PA 12/14/2007
K092257 FIDIA ADVANCED BIOPOLYMERS SRL JALOSKIN 01/26/2010
K143124 FOSHAN UNITED MEDICAL TECHNOLOGIES LTD. KA01 Chitosan Wound Dressing 01/26/2015
K172570 Foshan United Medical Technologies, Ltd. ALGS6 Ag Alginate Wound Dressing 05/11/2018
K150914 Founders Science Group, LLC Dash-Topic Plus Cream 04/21/2016
K172010 gel-e, Inc. (formerly Remedium Technologies, Inc.) gel-e Bandage 12/07/2017
K183681 Global Health Solutions (DBA Turn Therapeutics) Protego Antimicrobial Wound Dressing 10/11/2019
K171191 Global Health Solutions, LLC Hexagen Derm 08/25/2017
K160872 GLOBAL HEALTH SOLUTIONS, LLC PolyPlex Wound Dressing 11/23/2016
K123193 GLYCOBIOSCIENCES, INC IPM WOUND GEL BIO 03/03/2014
K143527 GLYCOBIOSCIENCES, INC IPM Wound Gel Bio, IPM Derm Gel Bio 04/20/2015
K123113 GLYCOBIOSCIENCES, INC L.A.M. IMP WOUND GEL 12/11/2012
K130781 GLYCOBIOSCIENCES, INC L.A.M. IPM WOUND GEL, IPM DERM GEL 02/14/2014
K100839 GORBEC PHARMACEUTICAL SERVICES, INC. BARIREP 05/11/2010
K223495 Hangzhou Zeo-Innov Life Technology Co., Ltd Zeolite Hemostatic Cotton 05/02/2023
K063517 HEALAGENICS, INC. HEALADEX-P 02/16/2007
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K160783 VOMARIS INNOVATIONS, INC. Procellera 09/07/2016
K180533 Vomaris Wound Care, Inc. Procellera Composite Antibacterial Wound Dressing 12/10/2018
K001519 WESTAIM BIOMEDICAL, INC. ACTICOAT 7 DRESSING 10/06/2000
K002466 WESTAIM BIOMEDICAL, INC. ACTICOAT COMPOSITE DRESSING 02/16/2001
K000051 WESTAIM BIOMEDICAL, INC. ACTICOAT FOAM DRESSING 04/05/2000
K010447 WESTAIM BIOMEDICAL, INC. MODIFICATION TO ACTICOAT FOAM DRESSING 03/15/2001
K992817 WILLIAM FEINSTEIN & ASSOCIATES, INC. ANTIBACTERIAL ADHESIVE BANDAGE 11/05/1999
K993969 WINCHESTER LABORATORIES LLC. SALJET SINGLE DOSE STERILE SALINE TOPICAL SOLUTION 12/30/1999
K181315 Winner Medical Co., Ltd Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing 02/14/2019
K221754 Winner Medical Co., Ltd. Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam Dressing (OTC); Silicone Ag Foam Dressing with Border (OTC) 01/17/2023
K191819 Winner Medical Co., Ltd. Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border 05/14/2020
K221311 Winner Medical Co., Ltd. Antibacterial Bandage 06/21/2023
K221755 Winner Medical Co., Ltd. Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing 01/13/2023
K221720 Winner Medical Co., Ltd. Extra Silver Gelling Fiber Dressing 12/21/2022
K192463 Winner Medical Co., Ltd. PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing with Border 05/14/2020
K221532 Winner Medical Co., Ltd. PHMB Wound Dressing 01/30/2023
K202982 Winner Medical Co., Ltd. Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use) 10/19/2021
K210466 Winner Medical Co., Ltd. Silver Gelling Fiber Dressing 01/14/2022
K192478 Zhejiang Longterm Medical Technology Co., Ltd. LT Antibacterial Alginate with Silver Dressing 06/17/2020


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