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 |
K041013 |
HEDONIST BIOCHEMICAL TECHNOLOGIES CO., LTD. |
SUILE OINTMENT WOUND DRESSING |
07/07/2004 |
K022967 |
HEDONIST BIOCHEMICAL TECHNOLOGIES CO., LTD. |
SUILE WOUND DRESSING |
07/08/2003 |
K152533 |
Helsinn Healthcare SA |
Xonrid Gel |
10/28/2016 |
K990861 |
HOSPITAL SPECIALTY CO. |
WOUND DRESSING/ABD PAD, MODEL #10810 |
04/12/1999 |
K120181 |
HUIZHOU FORYOU MEDICAL DEVICES CO, LTD |
LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM |
02/14/2013 |
K141619 |
HUIZHOU FORYOU MEDICAL DEVICES CO, LTD |
LUOFUCON SILVER FOAM DRESSING |
04/06/2015 |
K172554 |
Huizhou Foryou Medical Devices Co., Ltd. |
LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing |
05/01/2018 |
K210718 |
Huizhou Foryou Medical Devices Co., Ltd. |
LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing |
03/23/2022 |
K201016 |
Huizhou Foryou Medical Devices Co., Ltd. |
LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC use) |
01/28/2021 |
K160022 |
HUIZHOU FORYOU MEDICAL DEVICES Co., Ltd. |
LUOFUCON Silicone Ag foam dressing |
08/17/2016 |
K170077 |
HUIZHOU FORYOU MEDICAL DEVICES Co., Ltd. |
LUOFUCON Silicone Ag Foam Dressing with Border |
03/30/2017 |
K140954 |
HUIZHOU FORYOU MEDICAL DEVICES Co., Ltd. |
LUOFUCON SILVER PU ANTIBACTERIAL FOAM DRESSING |
03/23/2015 |
K211123 |
Huizhou Foryou Medical Devices CO., Ltd. |
LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel |
04/22/2022 |
K190268 |
Hydrofera, LLC |
Hydrofera Blue READY - Border |
11/06/2019 |
K013462 |
HYDROFERA, LLC. |
HYDROFERA BACTERIOSTATIC WOUND DRESSING |
01/11/2002 |
K023138 |
HYDROFERA, LLC. |
HYDROFERA BACTERIOSTATIC WOUND DRESSING |
01/17/2003 |
K130670 |
HYDROFERA, LLC. |
HYDROFERA BLUE PU BACTERIOSTATIC DRESSING |
01/02/2014 |
K123724 |
IGI LABORATORIES, INC. |
DERMISEB CREAM |
08/28/2013 |
K123678 |
IGI LABORATORIES, INC. |
HYALMIX CREAM |
12/16/2013 |
K153756 |
IMBED BIOSCIENCES, INC. |
Microlyte Ag |
08/04/2016 |
K133542 |
INNOVACYN, INC. |
PURACYN PLUS SKIN AND WOUND |
04/28/2014 |
K150799 |
INNOVACYN, INC. |
Puracyn(R) Plus Duo-Care(TM) Antimicrobial Wound & Skin Hydrogel, Puracyn(R) Plus Antimicrobial Hydrogel Professional Formula |
11/19/2015 |
K020041 |
INSTITUT BIOCHIMIQUE SA (IBSA) |
IALUSET HYDROCOLLOID |
03/14/2002 |
K003229 |
INTEGRA LIFESCIENCES CORP. |
BIOPATCH ANTIMICROBIAL DRESSING |
10/26/2001 |
K990086 |
INTEGRA LIFESCIENCES CORP. |
HELIDERM COLLAGEN WOUND DRESSINGS 0.5 GRAM AND 1.0 GRAM |
03/31/1999 |
K140905 |
INVADO PHARMACEUTICALS |
DERMAFINE |
05/08/2015 |
K143605 |
ISDIN Corp |
Nutraseb Facial Cream |
04/14/2016 |
K161991 |
IZUN PHARMACEUTICALS |
Curasite |
03/03/2017 |
K201324 |
Jiangsu Excellence Medical Supplies Co., Ltd |
Antibacterial Bandage |
02/05/2021 |
K173005 |
Jiangsu Newvalue Medical Producst Co.,Ltd |
SURECELL Gelling Fiber Wound Dressing |
05/25/2018 |
K213413 |
Jiangsu NewValue Medical Products Co., Ltd. |
Hemostatic Dressing |
09/01/2023 |
K001023 |
JOHNSON & JOHNSON CONSUMER COMPANIES, INC. |
FREEDOM, MODEL 4660 |
09/22/2000 |
K022483 |
JOHNSON & JOHNSON MEDICAL, LTD. |
ACTISORB SILVER 220 ANTIMICROBIAL BINDING DRESSING |
02/03/2003 |
K033523 |
JOHNSON & JOHNSON MEDICAL, LTD. |
COLLAGEN-ORC ANTIMICROBIAL MATRIX |
10/21/2004 |
K014129 |
JOHNSON & JOHNSON MEDICAL, LTD. |
PROMOGRAN MATRIX WOUND DRESSING |
02/14/2002 |
K223259 |
Kane Biotech, Inc. |
coactiv+Ö Antimicrobial Wound Gel |
05/24/2023 |
K973511 |
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH |
KENDALL CURITY PETROLATUM GAUZE |
12/16/1997 |
K973507 |
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH |
KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317) |
12/15/1997 |
K080949 |
KERATEC LIMITED |
KERATEC WOUND DRESSINGS |
02/11/2009 |
K220566 |
KOAG LLC |
Vascette HP (hemostatic pad) |
07/29/2022 |
K080010 |
KYTOGENICS, INC |
NOCC HYDROPHILIC WOUND DRESSING |
03/14/2008 |
K062559 |
LABORATOIRES URGO |
URGOCELL AG ANTIMICROBIAL WOUND DRESSING WITH SILVER |
01/29/2007 |
K100429 |
LABORATOIRES URGO |
URGOCELL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER |
06/11/2010 |
K123219 |
LABORATOIRES URGO |
URGOCLEAN ABSORBENT WOUND DRESSING |
03/18/2013 |
K143017 |
LABORATOIRES URGO |
Urgoclean Ag, Antibacterial Absorbent Wound Dressing with Silver |
08/07/2015 |
K061220 |
LABORATOIRES URGO |
URGOTUL AG |
07/27/2006 |
K100430 |
LABORATOIRES URGO |
URGOTUL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER |
06/11/2010 |
K121227 |
LINKS MEDICAL PRODUCTS, INC. |
MANUKA FILL |
05/23/2012 |
K131796 |
LINKS MEDICAL PRODUCTS, INC. |
MANUKA FILL WOUND DRESSING |
03/14/2014 |
K133934 |
LINKS MEDICAL PRODUCTS, INC. |
MANUKA FOAM HC, MANUKA FOAM HC (WITH ACRYLIC ADHESIVE BORDER), MANUKA FOAM HC (WITH SILICONE ADHESIVE BORDER) |
05/02/2014 |
K120976 |
LINKS MEDICAL PRODUCTS, INC. |
MANUKA IG |
05/23/2012 |
K170270 |
LS Scientific Inc. D.B.A. KSE Scientific |
Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline |
06/23/2017 |
K133729 |
MANUKA HEALTH NEW ZEALAND LTD. |
WOUND DRESSING WITH MANUKA HONEY |
01/23/2015 |
K102659 |
MANUKA MEDICAL LIMITED |
MANUKAHD, MANUKAHD ROPE, MANUKAHD BORDER |
12/08/2010 |
K092689 |
MANUKA MEDICAL LIMITED |
MANUKAPLI WOUND DRESSING |
05/20/2010 |
K110042 |
MANUKA MEDICAL LIMITED |
MANUKATEX |
03/24/2011 |
K102002 |
MARINE POLYMER TECHNOLOGIES |
TALYMED |
07/28/2010 |
K070557 |
MARINE POLYMER TECHNOLOGIES, INC. |
MP 719 |
05/23/2007 |
K160695 |
Marine Polymer Technologies, Inc. |
Talymed Suspension |
12/06/2016 |
K082856 |
MCGRATH PHARMACEUTICALS, INC. |
CARAPASTE ORAL WOUND DRESSING |
10/15/2008 |
K090092 |
MCMERLIN DENTAL PRODUCTS LP |
SOCKIT! AND MCMERLIN DERMAL WOUND GEL |
05/11/2009 |
K193439 |
MEBO Life Science Inc. |
MEBO Wound Dressing |
09/04/2020 |
K222657 |
MEBO Life Science Inc. |
MEBO Wound Dressing |
10/18/2022 |
K180643 |
MedCu Technologies, Ltd. |
MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs) |
11/23/2018 |
K063063 |
MEDICAL MOLECULAR THERAPUETICS LLC |
SILVACIDE SKIN & WOUND MOISTURIZING SOLUTION |
07/03/2007 |
K063069 |
MEDICAL MOLECULAR THERAPUETICS LLC |
SILVAKLENZ SKIN AND WOUND CLENSER SOLUTION |
07/13/2007 |
K152519 |
MEDICAL TECHNOLOGY RESEARCH INC. |
MTR550 (Tentative) Antimicrobial Silver Wound Gel |
06/02/2016 |
K110062 |
MEDIPURPOSE PTE. LTD. |
MEDIPLUS-FOAM AG; MEDIPLUS-COMFORTFOAM AG; MEDIPLUS-SUPERFOAM AG |
09/01/2011 |
K113583 |
MEDLINE INDUSTRIES, INC. |
CURAD ANTIBACTERIAL BANDAGE |
04/12/2012 |
K173911 |
Medline Industries, Inc. |
Medline Burn and Wound Dressing |
07/19/2018 |
K190224 |
Medline Industries, Inc. |
Medline Burn and Wound Dressing (OTC) |
03/08/2019 |
K093349 |
MEDLINE INDUSTRIES, INC. |
MEDLINE CURAD WOUND DRESSINGS |
01/07/2010 |
K052720 |
MEDLINE INDUSTRIES, INC. |
MEDLINE IODOFORM PACKING STRIPS |
10/20/2005 |
K173276 |
Medline Industries, Inc. |
Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP |
07/02/2018 |
K071552 |
MEDLINE INDUSTRIES, INC. |
PURACOL PLUS AG COLLAGEN MICROSCAFFOLD WOUND DRESSING |
04/25/2008 |
K042164 |
MEDLINE INDUSTRIES, INC. |
SILVER ANTIMICROBIAL WOUND GAUZE (SPONGE) |
06/09/2005 |
K100693 |
MEDTRADE PRODUCTS LIMITED |
AQUANOVA AG SUPER ABSORBANT DRESSING, AQUANOVA AG ANTIMICROBIAL DRESSING |
08/10/2010 |
K120930 |
MEDTRADE PRODUCTS LTD. |
CHG ANTIBACTERIAL FOAM DRESSING, CHG ANTIBACTERIAL PATCH, CHG ANTIBACTERIAL FOAM PATCH, CHG PATCH, CHG DRESSING |
10/26/2012 |
K033732 |
MEDTRADE PRODUCTS LTD. |
MEDTRADE PRODUCTS ANTISEPTIC BARRIER SILVER FOAM DRESSING, MODEL 09912450 |
12/01/2004 |
K093544 |
MIDLOTHIAN LABORATORIES |
TROPAZONE CR |
02/16/2010 |
K090337 |
MIDLOTHIAN LABORATORIES |
TROPAZONE LOTION |
08/13/2009 |
K093188 |
MILLIKEN & CO. |
AFM ULTRA AG DRESSINGS |
02/17/2010 |
K083659 |
MILLIKEN & CO. |
SILVER WOUND PAD |
04/16/2009 |
K051445 |
MILLIKEN CHEMICAL |
MILLIKEN SILVER WOUND DRESSINGS |
08/22/2005 |
K103141 |
MILLIKEN HEALTHCARE PRODUCTS, LLC |
LOW ADHERENT AFM AG DRESSINGS |
01/21/2011 |
K141603 |
MILLIKEN HEALTHCARE PRODUCTS, LLC |
Ultra Silver Dressings |
10/22/2014 |
K050842 |
MODERN MEDICAL EQUIPMENT MFG., LTD. |
AGCEL WOUND DRESSING,AGCEL BURN DRESSING |
08/02/2006 |
K061554 |
MOLNLYCKE HEALTH CARE |
MEPILEX AG ABSORBENT SILICONE-COATED DRESSING |
01/25/2007 |
K100029 |
MOLNLYCKE HEALTH CARE |
MEPILEX BORDER AG DRESSING |
09/15/2010 |
K123892 |
MOLNLYCKE HEALTH CARE |
MEPILEX TRANSFER AG |
04/05/2013 |
K130040 |
MOLNLYCKE HEALTH CARE |
MEPITEL AG |
02/12/2014 |
K160379 |
MOLNLYCKE HEALTH CARE, US LLC |
Exufiber Ag+ |
08/25/2016 |
K955863 |
MOLNLYCKE/SCOTT HEALTH CARE |
ALLDRESS MULTI LAYERED WOUND DRESSING |
03/13/1996 |
K071354 |
MONLYCKE HEALTH CARE |
MEPILEX AG DRESSING |
07/13/2007 |
K123904 |
MUELLER MEDICAL INTERNATIONAL LLC |
PROTHELIAL |
08/07/2013 |
K112666 |
NANOPLAS, INC. |
SALINE WOUND WASH |
04/20/2012 |
K141660 |
NAWA HEILMITTEL GMBH |
NAWALUTION SKIN AND WOUND CLEANSER |
10/31/2014 |
K123910 |
NEILMED PHARMACEUTICALS, INC. |
WOUNDWASH SALINE SPRAY |
10/29/2013 |
K100948 |
NEVOA LIFE SCIENCES, LLC |
HYPO CLENZ WOUND WASH MODEL 100 PPM |
02/02/2011 |
K203835 |
Next Science, LLC |
MIS Solution |
04/23/2021 |
K150792 |
NEXT SCIENCE, LLC |
Next Science Wound Gel |
12/17/2015 |
K163188 |
Next Science, LLC |
Next Science Wound Gel (Rx) |
03/06/2017 |
K203446 |
Next Science, LLC |
TorrentX Wound Wash |
09/23/2021 |
K132329 |
NIVAGEN PHARMACEUTICALS INC. |
NIVATOPIC PLUS |
12/20/2013 |
K033587 |
NOBLE FIBER TECHNOLOGIES |
SILVERSEAL |
08/05/2004 |
K033900 |
NOBLE FIBER TECHNOLOGIES |
X-STATIC SILVERSEAL HYDROCOLLOID FILM AND ISLAND DRESSING |
01/14/2005 |
K050649 |
NOBLE FIBER TECHNOLOGIES, INC. |
SILVERSEAL CONTACTING WOUND DRESSING WITH X-STATIC |
06/13/2005 |
K050726 |
NOBLE FIBER TECHNOLOGIES, INC. |
SILVERSEAL SILVERAID WITH X-STATIC |
12/05/2005 |
K113820 |
NOVABAY PHARMACEUTICALS |
NEUTROPHASE ANTIMICROBIAL WOUND CLEANSER |
08/08/2012 |
K071056 |
NOVABAY PHARMACEUTICALS |
NEUTROPHASE WOUND CLEANSER |
09/28/2007 |
K131542 |
Novabay Pharmaceuticals, Inc |
NEUTROPHASE(R) SKIN AND WOUND CLEANSER OTC |
07/24/2013 |
K063805 |
NUCRYST PHARMACEUTICALS, INC. |
SILCRYST SILVER ANTIMICROBIAL WOUND CREAM, MODEL A-00901 |
07/13/2007 |
K083042 |
NURSE ASSIST, INC. |
WOUND FLUSH, STERILE WATER & NORMAL SALINE |
12/18/2008 |
K121407 |
O2S, LLC |
OXYBAND WOUND DRESSING |
07/09/2012 |
K143590 |
OCULUS INNOVATIVE SCIENCES |
Alevicyn SG Antipruritic Gel |
06/04/2015 |
K152945 |
OCULUS INNOVATIVE SCIENCES |
Alevicyn SG Antipruritic Gel |
12/15/2015 |
K152055 |
OCULUS INNOVATIVE SCIENCES |
Ceramax Skin Barrier Cream |
11/23/2015 |
K141012 |
OCULUS INNOVATIVE SCIENCES |
HYDROCLEANSE WOUND CARE SOLUTION |
08/08/2014 |
K162217 |
Oculus Innovative Sciences |
LOYON |
03/23/2017 |
K153648 |
OCULUS INNOVATIVE SCIENCES |
Microcyn Plus Skin and Wound Hydrogel |
04/19/2016 |
K161034 |
OCULUS INNOVATIVE SCIENCES |
Microcyn Plus Wound Care Solution |
08/19/2016 |
K060113 |
OCULUS INNOVATIVE SCIENCES, INC. |
DERMACYN WOUND CARE |
02/22/2006 |
K042729 |
OCULUS INNOVATIVE SCIENCES, INC. |
DERMACYN WOUND IRRIGATION |
05/17/2005 |
K093585 |
OCULUS INNOVATIVE SCIENCES, INC. |
MICROCYN SKIN AND WOUND HYDROGEL |
03/08/2010 |
K041161 |
OCULUS INNOVATIVE SCIENCES, INC. |
MICROCYN WOUND CARE DRESSING |
05/03/2005 |
K090725 |
OCULUS INNOVATIVE SCIENCES, INC. |
OCULUS MICROCYN WOUND GEL |
05/20/2009 |
K090206 |
OCULUS INNOVATIVE SCIENCES, INC. |
OCULUS PURACYN ANTIMICROBIAL SKIN AND WOUND CLEANSER |
06/02/2009 |
K102945 |
OCULUS INNOVATIVE SCIENCES, INC. |
PEDIACYN ATOPIC DERMATITIS HYDROGEL |
02/02/2011 |
K211972 |
Omeza, LLC |
Omeza Collagen Matrix |
09/01/2021 |
K051647 |
ORGANOGENESIS, INC. |
FORTADERM ANTIMICROBIAL WOUND DRESSING |
11/08/2005 |
K043063 |
OXYBAND TECHNOLOGIES, INC. |
OXYBAND WOUND DRESSING |
03/24/2005 |
K043587 |
PATRICK D. MCGRATH PH.D |
SUCRALFATE AND CARAFATE PASTE KITS |
02/03/2006 |
K153678 |
PERMEADERM, INC. |
PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove |
08/08/2016 |
K130553 |
PHARMAPLAST S.A.E. |
ABSOCLEAR |
07/03/2013 |
K113807 |
PIERRE FABRE MEDICAL DEVICES |
DEXERYL CREAM |
03/07/2012 |
K200821 |
Planet (Suzhou) Medical Products Co., Ltd |
anti-bacterial bandage |
10/19/2020 |
K092348 |
POLYREMEDY, INC. |
POLY FIT HIGH HYDRATING ANTIMICROBIAL DRESSINGS |
04/08/2010 |
K092351 |
POLYREMEDY, INC. |
POLY FIT + ABSORBING AND HIGH ABSORBING ANTIMICROBIAL DRESSINGS |
04/08/2010 |
K121522 |
POLYREMEDY, INC. |
POLYFIT ABSORBING ANTIMICROBIAL DRESSINGS (OTC) |
06/27/2012 |
K110727 |
PRECISION DERMATOLOGY INCORPORATED |
HYLATOPICPLUS CREAM |
04/01/2011 |
K121559 |
PRECISION DERMATOLOGY INCORPORATED |
HYLATOPICPLUS LOTION |
11/30/2012 |
K111168 |
PRECISION DERMATOLOGY INCORPORATED |
PRECISION SKIN EMULSION |
12/13/2011 |
K082330 |
PRIMARY CARE SOLUTIONS, INC. |
PRIMARY CARE SOLUTIONS, INC., STERILE WATER AND SALINE FOR IRRIGATION |
10/09/2008 |
K122634 |
PROGRESSIVE WOUNDCARE TECHNOLOGIES, LLC |
IODOFOAM IODOPHOR FOAM DRESSING |
03/12/2013 |
K110732 |
PRUGEN IP HOLDINGS, INC |
EMULSION SB |
06/03/2011 |
K113772 |
PRUGEN IP HOLDINGS, INC |
HPR EMOLLIENT FOAM |
02/09/2012 |
K113774 |
PRUGEN IP HOLDINGS, INC |
HPR PLUS EMOLLIENT FOAM |
02/09/2012 |
K093159 |
PRUGEN IP HOLDINGS, INC |
PR CREAM |
06/24/2010 |
K093156 |
PRUGEN IP HOLDINGS, INC |
PRUCLAIR NONSTEROIDAL CREAM |
06/24/2010 |
K092878 |
PRUGEN IP HOLDINGS, INC |
PRUTECT TOPICAL OINTMENT, MODELS 45 GRAM TUBE, 90 GRAM TUBE |
01/15/2010 |
K082089 |
PRUGEN, INC. |
PRUMYX CREAM |
01/13/2009 |
K092232 |
PURICORE INC. |
MODIFICATION TO:VASHE WOUND CLEANSING SYSTEM, MODEL 9000-0014 |
08/19/2009 |
K141863 |
PURICORE INC. |
PURICORE WOUND HYDROGEL SPRAY DRESSING |
05/14/2015 |
K093155 |
PURICORE INC. |
VASHE WOUND CLEANSING SYSTEM |
03/01/2010 |
K131848 |
PURICORE INC. |
VASHE WOUND SOLUTION (4.0 OZ), (8.5 OZ & (16.0 OZ) |
03/31/2014 |
K093697 |
PURICORE INC. |
VASHE WOUND THERAPY SOLUTION |
04/13/2010 |
K100918 |
PURICORE INC. |
VASHE WOUND THERAPY SYSTEM MODEL: 9000-0014 |
08/09/2010 |
K123071 |
PURICORE, INC. |
VASHE SKIN AND WOUND HYDROGEL |
01/24/2013 |
K123072 |
PURICORE, INC. |
VASHE WOUND THERAPY SOLUTION |
02/14/2013 |
K220673 |
Qingdao Bright Moon Biomedical Materials Co., Ltd. |
Sterile Silver Alginate Wound Dressing |
03/16/2023 |
K070309 |
QUINNOVA PHARMACEUTICALS |
NEOSALUS |
09/12/2008 |
K090585 |
QUINNOVA PHARMACEUTICALS |
NEOSALUS CREAM |
04/02/2009 |
K091719 |
QUINNOVA PHARMACEUTICALS |
NEOSALUS LOTION |
07/30/2009 |
K060832 |
RETRO-TECH, LLC |
RETRO-TECH DRESSING |
03/13/2007 |
K070463 |
REVALESIO CORPORATION |
REVERA WOUND CARE, MODEL MDW0060 |
05/07/2008 |
K160192 |
ROCHAL INDUSTRIES LLC |
Atteris Antimicrobial Skin & Wound Cleanser |
07/28/2016 |
K161212 |
ROCHAL INDUSTRIES LLC |
Atteris Antimicrobial Skin Protectant |
09/30/2016 |
K192527 |
Rochal Industries, LLC |
Rochal Antimicrobial Wound Gel |
02/07/2020 |
K223377 |
Rochal Technologies LLC |
BIASURGE Advanced Surgical Solution |
03/30/2023 |
K181478 |
Roosin Medical Co., Ltd |
Roosin Xeroform Petrolatum Dressing |
09/13/2019 |
K143335 |
Roosin Medical Devices Co., Ltd |
Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with Preservative (OTC) |
06/01/2015 |
K151186 |
SARASOTA MEDICAL PRODUCTS, INC. |
Stay Fresh Hydrocolloid dressing |
11/27/2015 |
K032983 |
SCIVOLUTION, INC. |
SENSITIVE SKIN ANTIBACTERIAL BANDAGES |
06/01/2004 |
K020318 |
SCIVOLUTIONS, INC |
SCIVOLUTIONS VARIOUS ANTIBACTERIAL BANDAGES |
02/03/2003 |
K040518 |
SELECT FABRICATORS, INC. |
SELECT FABRICATORS, INC., AGMED TEX WOUND DRESSING |
10/27/2004 |
K113693 |
SERIOUSLY CLEAN LTD |
NIXALL TM WOUND AND SKIN CARE |
12/11/2012 |
K090823 |
SEWON CELLONTECH CO., LTD. |
THERAFORM BILAYER |
10/22/2009 |
K152544 |
SHENZHEN YUANXING NANO-PHARMA CO., LTD |
Agem Ag Mesh Dressing with Silver |
05/23/2016 |
K060237 |
SILVERLEAF MEDICAL PRODUCTS, INC. |
CMB ANTIMICROBIAL DRESSING |
06/15/2006 |
K081977 |
SILVERLEAF MEDICAL PRODUCTS, INC. |
PROSIT WOUND TREATMENT DEVICE |
12/01/2008 |
K013936 |
SILVERLEAF TECHNOLOGIES INC |
SILVERLEAF CONTACT WOUND DRESSING |
03/18/2003 |
K181074 |
Simple Science LLC |
Simple Science Antimicrobial Facial and Eyelid Cleanser |
08/17/2018 |
K142592 |
SIMPLE SCIENCE, LLC |
CleanSmart Wound Cleanser |
09/02/2015 |
K160095 |
Simple Science, LLC |
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 |
06/10/2016 |
K013056 |
SINCLAIR PHARMACEUTICALS, LTD. |
GELCLAIR CONCENTRATED ORAL GEL |
12/21/2001 |
K050158 |
SINCLAIR PHARMACEUTICALS, LTD. |
SINCLAIR SEBORRHEA EMULSION |
10/11/2006 |
K222189 |
SiOxMed, LLC. |
SiOxD Wound Matrix |
11/18/2022 |
K153723 |
Smith & Nephew Medical Limited |
ACTICOAT Surgical Dressing |
09/14/2016 |
K223526 |
Smith & Nephew Medical Limited |
ALLEVYN 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 Com |
08/18/2023 |
K161289 |
SMITH & NEPHEW MEDICAL LIMITED |
DURAFIBER Ag |
08/03/2016 |
K190756 |
Smith & Nephew Medical Ltd. |
IODOFLEX |
12/20/2019 |
K190730 |
Smith & Nephew Medical Ltd. |
IODOSORB |
12/20/2019 |
K103793 |
Smith & Nephew, Inc |
DURAFIBER AG |
05/02/2011 |
K083113 |
SMITH & NEPHEW, INC. |
ACTICOAT FLEX 7 DRESSING |
07/22/2009 |
K050030 |
SMITH & NEPHEW, INC. |
ACTICOAT MOISTURE CONTROL DRESSING |
04/21/2005 |
K063835 |
SMITH & NEPHEW, INC. |
ALLEVYN AG DRESSING |
08/03/2007 |
K171727 |
Sonoma Pharmaceuticals |
Hydrocleanse Antimicrobial Skin and Wound Care Solution |
07/26/2017 |
K172622 |
Sonoma Pharmaceuticals |
Microcyn Antimicrobial Skin and Wound Cleanser |
11/21/2017 |
K171935 |
Sonoma Pharmaceuticals, Inc. |
Alevicyn SG Antimicrobial Gel |
12/01/2017 |
K173896 |
Sonoma Pharmaceuticals, Inc. |
Microcyn Antimicrobial Hydrogel |
04/02/2018 |
K172851 |
Sonoma Pharmaceuticals, Inc. |
Microcyn Plus Antimicrobial Wound Care Solution |
11/15/2017 |
K083334 |
SOUTHWEST TECHNOLOGIES, INC. |
ELASTO-GEL MANUKA HONEY WOUND DRESSING |
07/30/2009 |
K102478 |
SOUTHWEST TECHNOLOGIES, INC. |
OTC ELASTO-GEL MANUKA HONEY WOUND DRESSING |
11/03/2010 |
K183208 |
Speciality Fibres and Materials Ltd. |
Suprasorb A + Ag ôRö |
08/15/2019 |
K173844 |
Specialty Fibres and Materials Ltd |
Titan Ag 200 |
08/09/2018 |
K071442 |
SPECIALTY FIBRES AND MATERIALS LTD. |
SUPRASORB A +AG |
05/01/2008 |
K213514 |
Spectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc. |
Spectricept Skin and Wound Cleanser |
01/13/2023 |
K212554 |
StemCyte Inc. |
Bonvadis Topical Cream |
08/19/2022 |
K060901 |
STERILOX TECHNOLOGIES, INC. |
VASHE WOUND CLEANSING SYSTEM |
06/29/2006 |
K972185 |
STERIPAK, LTD. |
20 ML NORMAL SALINE TOPICAL SOLUTION, 0.9% W/V SODIUM CHLORIDE |
03/05/1998 |
K110172 |
STRATUS PHARMACEUTICAL |
SONAFINE WOUND DRESSING |
08/19/2011 |
K161311 |
STRUKMYER MEDICAL LLC |
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 |
08/29/2016 |
K182725 |
SweetBio, Inc |
Apis |
05/31/2019 |
K073610 |
SWISS AMERICAN PRODUCTS, INC. |
ELTA ADVANCED WOUND WASH |
04/23/2008 |
K071703 |
SWISS AMERICAN PRODUCTS, INC. |
ELTA SILVER ANTIMICROBIAL WOUND GEL DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC |
08/22/2007 |
K103713 |
SWISS AMERICAN PRODUCTS, INC. |
ELTA WOUND CLEANSER |
06/16/2011 |
K143444 |
Synedgen Inc. |
SynePure Wound Cleanser |
08/21/2015 |
K172338 |
Synedgen, Inc |
Catasyn Advanced Technology Wound Hydrogel |
02/21/2018 |
K100261 |
TEI BIOSCIENCES INC. |
PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD |
12/10/2010 |
K061227 |
THE HYMED GROUP CORP. |
HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER |
12/20/2006 |
K132891 |
THE HYMED GROUP CORP. |
HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER |
06/19/2014 |
K002896 |
THE WESTAIM CORP. |
ACTICOAT FOAM DRESSING, ALGISITE M CALCIUM ALGINATE DRESSING |
02/21/2001 |
K150676 |
Theo Manufacturing BV |
L-Mesitran Dressing Family II- Soft and Tulle |
12/23/2015 |
K053613 |
THEO MANUFACTURING BV |
L-MESITRAN HYDRO, L-MESITRAN BORDER, L-MESITRAN NET, L-MESITRAN ACTIVE |
07/25/2007 |
K081246 |
TISSUE TECHNOLOGIES HOLDINGS, LLC |
TT-102 |
08/13/2009 |
K061060 |
TISSUE TECHNOLOGIES HOLDINGS, LLC |
TT101, MODELS TT 101-1,-2,-3,-4,-5,-6,-7,-8 |
07/03/2006 |
K080524 |
TRI-STATE HOSPITAL SUPPLY CORP. |
CENTURION SORBAVIEW OTC |
04/23/2008 |
K110762 |
TRIGEN LABORATORIES, INC. |
AVO BARRIER TOPICAL EMULSION |
11/18/2011 |
K121134 |
TRIGEN LABORATORIES, INC. |
TL TRISEB CREAM |
07/25/2012 |
K110757 |
TRIGEN LABORATORIES, INC. |
TL-CERMIDE SKIN BARRIER EMULSION |
08/19/2011 |
K051542 |
TRIOSYN CORP. |
TRIOSYN T40 ANTIMICROBIAL WOUND DRESSING |
03/17/2006 |
K070685 |
TYCO HEALTHCARE |
KENDALL ANTIMICROBIAL DRAIN DRESSING FOR OTC USE, MODEL 6662 |
09/14/2007 |
K070653 |
TYCO HEALTHCARE |
KENDALL KERLIX ANTIMICROBIAL SUPER SPONGE DRESSING FOR OTC USE, MODEL 6662 |
09/12/2007 |
K033453 |
TYCO HEALTHCARE |
KENDALL ULTEC PRO AG+ HYDROCOLLOID DRESSING |
04/29/2004 |
K071371 |
TYCO HEALTHCARE GROUP, LP |
COPA AMD ANTIMICROBIAL WOUND DRESSING |
11/19/2007 |
K220286 |
V3bio Sdn. Bhd |
ELECTROCYN soma |
12/21/2022 |
K173549 |
Valeant Pharmaceuticals |
BIAFINE |
08/13/2018 |
K142775 |
Vigilenz Medical Devices |
Neuwater TM (HydrocynTM aqua) |
02/13/2015 |
K172747 |
VIRCHOW BIOTECH PVT LTD |
HYALURONIC ACID TOPICAL WOUND CREAM |
04/27/2018 |
K153565 |
VIRCHOW BIOTECH PVT. LTD. |
DONASORB SILVER WOUND DRESSING |
09/22/2016 |
K132326 |
VIRCHOW BIOTECH PVT. LTD. |
IONSIL GEL |
08/21/2014 |
K130350 |
VOMARIS INNOVATIONS INC. |
PROCELLERA |
07/02/2013 |
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 |