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Dressing, Wound, Drug

FDA product code FRO · 659 cleared devices

Class U Unknown

Review panel: SU
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1978-03-28 – 2026-09-22

FRO 2019-12-20

IODOSORB

Applicant Smith & Nephew Medical, Ltd.

K number K190730

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FRO 2019-11-06

Hydrofera Blue READY - Border

Applicant Hydrofera, LLC

K number K190268

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FRO 2019-10-18

BIAFINE Topical Cream

Applicant Bausch Health Americas Incorporated

K number K190342

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FRO 2019-10-11

Protego Antimicrobial Wound Dressing

Applicant Global Health Solutions (Dba Turn Therapeutics)

K number K183681

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FRO 2019-09-20

Clyra Wound Irrigation Solution

Applicant Clyra Medical Technologies, Inc.

K number K181428

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FRO 2019-09-13

Roosin Xeroform Petrolatum Dressing

Applicant Roosin Medical Co., Ltd.

K number K181478

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FRO 2019-09-12

Saline Wound Wash, SteriCleanse(TM)

Applicant Ascent Consumer Products, Inc.

K number K183662

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FRO 2019-08-15

Suprasorb A + Ag “R”

Applicant Speciality Fibres and Materials, Ltd.

K number K183208

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FRO 2019-07-25

Silicone PHMB Foam Wound Dressing

Applicant Advanced Medical Solutions, Ltd.

K number K190819

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FRO 2019-07-18

Silverlon Wound Contact, Burn Contact Dressings

Applicant Argentum Medical, LLC

K number K190343

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FRO 2019-05-31

Apis

Applicant Sweetbio, Inc.

K number K182725

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FRO 2019-05-29

Silver High Performance Dressing

Applicant Advanced Medical Solutions, Ltd.

K number K183645

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FRO 2019-03-08

Medline Burn and Wound Dressing (OTC)

Applicant Medline Industries, Inc.

K number K190224

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FRO 2019-02-14

Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing

Applicant Winner Medical Co., Ltd.

K number K181315

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FRO 2019-01-14

Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing)

Applicant Argentum Medical, LLC

K number K180570

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FRO 2018-12-14

AC5 Topical Gel

Applicant Arch Therapeutics, Inc.

K number K182681

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FRO 2018-12-10

Procellera Composite Antibacterial Wound Dressing

Applicant Vomaris Wound Care, Inc.

K number K180533

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FRO 2018-12-06

KerraContact Ag Perf Advanced Perforated Silver Wound Dressing

Applicant Exciton Technologies, Inc.

K number K182680

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FRO 2018-11-23

MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs)

Applicant Medcu Technologies , Ltd.

K number K180643

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FRO 2018-09-07

AMSure Sterile Water, and Sterile Normal Saline for Wound Flush

Applicant Amsino International, Inc.

K number K181423

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FRO 2018-08-17

Simple Science Antimicrobial Facial and Eyelid Cleanser

Applicant Simple Science, LLC

K number K181074

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FRO 2018-08-13

BIAFINE

Applicant Valeant Pharmaceuticals

K number K173549

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FRO 2018-08-09

Titan Ag 200

Applicant Specialty Fibres and Materials, Ltd.

K number K173844

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FRO 2018-08-07

Surgical Silver Post Operative Dressing

Applicant Advanced Medical Solutions, Ltd.

K number K180634

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FRO 2018-08-03

PHMB Foam Wound Dressing

Applicant Advanced Medical Solutions, Ltd.

K number K181197

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FRO 2018-07-20

AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber

Applicant Convatec Limited

K number K173675

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FRO 2018-07-19

Medline Burn and Wound Dressing

Applicant Medline Industries, Inc.

K number K173911

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FRO 2018-07-02

Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP

Applicant Medline Industries, Inc.

K number K173276

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FRO 2018-05-11

ALGS6 Ag Alginate Wound Dressing

Applicant Foshan United Medical Technologies, Ltd.

K number K172570

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FRO 2018-05-01

LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing

Applicant Huizhou Foryou Medical Devices Co., Ltd.

K number K172554

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FRO 2018-04-27

HYALURONIC ACID TOPICAL WOUND CREAM

Applicant Virchow Biotech Pvt, Ltd.

K number K172747

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FRO 2018-04-13

Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC)

Applicant Aquilabs Us, LLC

K number K180305

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FRO 2018-04-04

Algidex Ag Silver Alginate Wound Dressing

Applicant Deroyal Industries, Inc.

K number K173072

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FRO 2018-04-02

Microcyn Antimicrobial Hydrogel

Applicant Sonoma Pharmaceuticals, Inc.

K number K173896

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FRO 2018-02-21

Catasyn Advanced Technology Wound Hydrogel

Applicant Synedgen, Inc.

K number K172338

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FRO 2017-12-01

Alevicyn SG Antimicrobial Gel

Applicant Sonoma Pharmaceuticals, Inc.

K number K171935

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FRO 2017-11-21

Microcyn Antimicrobial Skin and Wound Cleanser

Applicant Sonoma Pharmaceuticals

K number K172622

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FRO 2017-11-21

3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced Securement Dressing

Applicant 3M Company, 3M Healthcare

K number K170754

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FRO 2017-11-17

Endoform Silver Dermal Template

Applicant Aroa Biosurgery

K number K172318

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FRO 2017-11-15

Microcyn Plus Antimicrobial Wound Care Solution

Applicant Sonoma Pharmaceuticals, Inc.

K number K172851

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FRO 2017-09-21

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 chloride) 250mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 500mL bottle

Applicant Anexa Biomedical, Inc.

K number K172486

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FRO 2017-08-25

Hexagen Derm

Applicant Global Health Solutions, LLC

K number K171191

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FRO 2017-08-22

SilverSeal

Applicant Alliqua Biomedical, Inc.

K number K171041

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FRO 2017-08-22

NEOCERA Advanced Barrier Cream

Applicant Exeltis USA Dermatology, LLC

K number K170911

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FRO 2017-08-21

Sorbact Wound Dressing-Ribbon Gauze

Applicant Abigo Medical AB

K number K171225

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FRO 2017-07-26

Hydrocleanse Antimicrobial Skin and Wound Care Solution

Applicant Sonoma Pharmaceuticals

K number K171727

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FRO 2017-07-25

PHMB Antimicrobial Foam Wound Dressing

Applicant Advanced Medical Solutions, Ltd.

K number K163062

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FRO 2017-07-17

BD ChloraShield IV Dressing with CHG Antimicrobial

Applicant Avery Dennison Belgie Bvba

K number K170407

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FRO 2017-06-23

Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline

Applicant Ls Scientific Inc. D.B.A. Kse Scientific

K number K170270

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FRO 2017-06-23

Cerdak Basic

Applicant Bu Polysciences Equipment & Trading, LLC

K number K153138

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FRO 2017-05-23

Prontosan Wound Gel

Applicant B.Braun Medical, Inc.

K number K163430

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FRO 2017-04-20

Ross Ru Wound Dressing Gel

Applicant Biotd S.A.

K number K162017

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FRO 2017-03-30

LUOFUCON Silicone Ag Foam Dressing with Border

Applicant Huizhou Foryou Medical Devices Co., Ltd.

K number K170077

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FRO 2017-03-29

ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG (10cm x 25cm)

Applicant Avery Dennison Corporation

K number K163529

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FRO 2017-03-23

LOYON

Applicant Oculus Innovative Sciences

K number K162217

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FRO 2017-03-06

Next Science Wound Gel (Rx)

Applicant Next Science, LLC

K number K163188

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FRO 2017-03-03

Curasite

Applicant Izun Pharmaceuticals

K number K161991

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FRO 2017-02-13

KerraCel Ag Gelling Fiber Silver Dressing

Applicant Exciton Technologies, Inc.

K number K162508

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FRO 2016-12-06

Talymed Suspension

Applicant Marine Polymer Technologies, Inc.

K number K160695

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FRO 2016-11-23

PolyPlex Wound Dressing

Applicant Global Health Solutions, LLC

K number K160872

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FRO 2016-11-10

Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL

Applicant B.Braun Medical, Inc.

K number K161623

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FRO 2016-10-28

Xonrid Gel

Applicant Helsinn Healthcare SA

K number K152533

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FRO 2016-10-03

Dynarex Xeroform Petrolatum Dressing

Applicant Dynarex Corporation

K number K152970

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FRO 2016-09-30

Atteris Antimicrobial Skin Protectant

Applicant Rochal Industries, LLC

K number K161212

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FRO 2016-09-22

DONASORB SILVER WOUND DRESSING

Applicant Virchow Biotech Pvt, Ltd.

K number K153565

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FRO 2016-09-14

Anexa Wound Flush, Sterile Water & Sterile Normal Saline

Applicant Anexa Biomedical, Inc.

K number K161658

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FRO 2016-09-14

ACTICOAT Surgical Dressing

Applicant Smith & Nephew Medical Limited

K number K153723

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FRO 2016-09-07

Procellera

Applicant Vomaris Innovations, Inc.

K number K160783

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FRO 2016-08-29

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

Applicant Strukmyer Medical, LLC

K number K161311

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FRO 2016-08-25

Exufiber Ag+

Applicant Molnlycke Health Care Us, LLC

K number K160379

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FRO 2016-08-19

Microcyn Plus Wound Care Solution

Applicant Oculus Innovative Sciences

K number K161034

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FRO 2016-08-17

LUOFUCON Silicone Ag foam dressing

Applicant Huizhou Foryou Medical Devices Co., Ltd.

K number K160022

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FRO 2016-08-08

PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove

Applicant Permeaderm, Inc.

K number K153678

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FRO 2016-08-04

Microlyte Ag

Applicant Imbed Biosciences, Inc.

K number K153756

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FRO 2016-08-03

DURAFIBER Ag

Applicant Smith & Nephew Medical Limited

K number K161289

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FRO 2016-07-28

Atteris Antimicrobial Skin & Wound Cleanser

Applicant Rochal Industries, LLC

K number K160192

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FRO 2016-07-21

Dakin's Skin and Wound Cleanser

Applicant Century Pharmaceuticals, Inc.

K number K150208

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FRO 2016-07-01

Sorbact Foam Gentle Border, Sorbact Superabsorbent

Applicant Abigo Medical AB

K number K153674

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FRO 2016-06-10

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

Applicant Simple Science, LLC

K number K160095

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FRO 2016-06-02

MTR550 (Tentative) Antimicrobial Silver Wound Gel

Applicant Medical Technology Research, Inc.

K number K152519

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FRO 2016-05-23

Agem Ag Mesh Dressing with Silver

Applicant Shenzhen Yuanxing Nano-Pharma Co., Ltd.

K number K152544

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FRO 2016-04-21

Dash-Topic Plus Cream

Applicant Founders Science Group, LLC

K number K150914

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FRO 2016-04-19

Microcyn Plus Skin and Wound Hydrogel

Applicant Oculus Innovative Sciences

K number K153648

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FRO 2016-04-14

Nutraseb Facial Cream

Applicant Isdin Corp.

K number K143605

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FRO 2016-02-05

AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX Wound Wash Skin and Wound Cleanser (OTC)

Applicant Abl Medical, LLC

K number K151185

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FRO 2016-01-21

AQUACEL Ag Surgical SP Dressing

Applicant Convatec Limited

K number K152926

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FRO 2013-12-20

NIVATOPIC PLUS

Applicant Nivagen Pharmaceuticals, Inc.

K number K132329

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FRO 2013-12-16

HYALMIX CREAM

Applicant Igi Laboratories, Inc.

K number K123678

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FRO 2013-10-29

WOUNDWASH SALINE SPRAY

Applicant Neilmed Pharmaceuticals, Inc.

K number K123910

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FRO 2013-10-08

PRONTOSAN WOUND GEL X

Applicant B.Braun Medical, Inc.

K number K130857

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FRO 2013-08-28

DERMISEB CREAM

Applicant Igi Laboratories, Inc.

K number K123724

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FRO 2013-08-07

PROTHELIAL

Applicant Mueller Medical International, LLC

K number K123904

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FRO 2013-07-24

NEUTROPHASE(R) SKIN AND WOUND CLEANSER OTC

Applicant Novabay Pharmaceuticals, Inc.

K number K131542

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FRO 2013-07-03

ABSOCLEAR

Applicant Pharmaplast S.A.E.

K number K130553

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FRO 2013-07-02

PROCELLERA

Applicant Vomaris Innovations, Inc.

K number K130350

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FRO 2013-06-06

AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE

Applicant Convatec, Inc.

K number K123481

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FRO 2013-06-06

CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSING

Applicant Coreleader Biotech Co., Ltd.

K number K123394

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FRO 2013-05-01

HYDROPERMEATE TOPICAL EMULSION, ANSWER2SKIN SUNBURN RELIEF CREAM, ANSWER2SKIN FIRST AID CREAM

Applicant Dermal Life, LLC

K number K122595

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FRO 2013-04-05

MEPILEX TRANSFER AG

Applicant Molnlycke Health Care

K number K123892

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FRO 2013-03-18

URGOCLEAN ABSORBENT WOUND DRESSING

Applicant Laboratoires Urgo

K number K123219

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