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Wound Dressing With Animal-Derived Material(S)

FDA product code KGN · 180 cleared devices

Class U Unknown

Review panel: SU
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1979-05-03 – 2026-09-09

KGN 2026-09-09

ColActive Plus

Applicant Covalon Technologies, Ltd.

K number K260652

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KGN 2026-08-27

Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP);Accelagen Plus Surgical Matrix, 5cc (CG-05AP);Accelagen Plus Surgical Strip, 125x25x2mm (CG-125X25AP);Accelagen Plus Surgical Strip, 250x25x2mm (CG-250X25AP)

Applicant Berkeley Advanced Biomaterials

K number K260711

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KGN 2026-07-02

Collagen Wound Powder

Applicant Ventris Medical

K number K260596

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KGN 2026-06-24

Endoform Dermal Template

Applicant Aroa Biosurgery , Ltd.

K number K260669

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KGN 2026-06-18

ECMT-100 WMD

Applicant Ecm Therapeutics, Inc.

K number K253521

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KGN 2026-06-05

Catalyze

Applicant BioTissue Holdings, Inc.

K number K253204

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KGN 2026-06-03

Roosin Collagen Powder

Applicant Roosin Medical Co., Ltd.

K number K254034

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KGN 2026-06-03

Roosin Collagen Dressing

Applicant Roosin Medical Co., Ltd.

K number K253974

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KGN 2026-05-14

MatriDerm

Applicant Medskin Solutions Dr. Suwelack AG

K number K261224

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KGN 2026-03-19

Derma-Gide

Applicant Geistlich Pharma AG

K number K260532

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KGN 2026-02-19

LacertaMatrix

Applicant Lacerta Life Sciences

K number K260218

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KGN 2026-02-10

CollOvine™ Wound Powder

Applicant Ovigenex, LLC

K number K253140

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KGN 2026-01-22

Device 104 Particulate

Applicant Geistlich Pharma AG

K number K251323

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KGN 2025-12-22

Theracor

Applicant Stimlabs, LLC

K number K253339

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KGN 2025-12-22

LacertaMatrix

Applicant Lacerta Life Science

K number K252673

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KGN 2025-12-19

MatriDerm pluS+ Bi-Layer

Applicant Medskin Solutions Dr. Suwelack AG

K number K250864

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KGN 2025-10-16

SurgiAid Collagen Wound Dressing (HA)

Applicant Maxigen Biotech, Inc.

K number K242100

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KGN 2025-10-10

Collagen Wound Dressing

Applicant Winner Medical Co., Ltd.

K number K252001

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KGN 2025-08-15

Helios Dermal Scaffold

Applicant Helios Biomedical, Inc.

K number K250397

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KGN 2025-07-16

Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus

Applicant Kerecis Limited

K number K251845

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KGN 2025-06-25

GeniPhys Collymer Self-Assembling Scaffold

Applicant Geniphys, Inc.

K number K250329

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KGN 2025-06-20

CollOvine™ Wound Dressing

Applicant Ovigenex, LLC

K number K242985

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KGN 2025-01-06

DermiSphere Dermal Template

Applicant Fesariustherapeutics, Inc.

K number K241904

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KGN 2024-12-19

Bovine Dermis Collagen Dermal Matrix

Applicant Collagen Matrix, Inc.

K number K243071

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KGN 2024-12-17

BIOBRANE Temporary Wound Dressing; BIOBRANE Glove

Applicant Smith & Nephew Medical Limited

K number K242146

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KGN 2024-10-18

Corplex P/ Theracor P/ Allacor P

Applicant Stimlabs, LLC

K number K242828

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KGN 2024-10-18

ABCcolla® Collagen ADM Scaffold

Applicant Acro Biomedical Co., Ltd.

K number K233378

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KGN 2024-08-21

Kerecis Parvus (50207)

Applicant Kerecis Limited

K number K241080

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KGN 2024-07-26

InnovaMatrix®FD

Applicant Convatec Triad Life Sciences, LLC

K number K241866

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KGN 2024-07-11

Cytal® Wound Matrix; Cytal® Burn Matrix

Applicant Acell, Inc.

K number K241724

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KGN 2024-07-11

MicroMatrix® UBM Particulate

Applicant Acell, Inc.

K number K241706

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KGN 2024-04-25

LUOFUCON® Collagen Particles (Collagen Wound Dressing)

Applicant Huizhou Foryou Medical Devices Co., Ltd.

K number K232796

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KGN 2024-04-19

Miro3D Fibers Wound Matrix

Applicant Reprise Biomedical, Inc.

K number K240753

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KGN 2024-04-19

ReyaGel (RG03 - MTP gel 3mL)

Applicant Fettech

K number K232204

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KGN 2024-03-01

MiroDry Wound Matrix

Applicant Reprise Biomedical, Inc.

K number K240277

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KGN 2024-02-02

Corplex P / Theracor P / Allacor P

Applicant Stimlabs, LLC

K number K231325

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KGN 2023-12-13

MiroTract Wound Matrix

Applicant Reprise Biomedical, Inc.

K number K231614

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KGN 2023-12-01

Comatryx OTC

Applicant Strukmyer Medical, LLC

K number K232758

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KGN 2023-11-13

Foundation Dermal Regeneration Scaffold (DRS) Solo

Applicant Bionova Medical, Inc.

K number K231937

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KGN 2023-10-12

Collagen Wound Dressing

Applicant Winner Medical Co., Ltd.

K number K231152

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KGN 2023-10-11

SurgiAid® Collagen Wound Dressing

Applicant Maxigen Biotech, Inc.

K number K223126

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KGN 2023-09-22

MicroMatrix® Flex

Applicant Acell, Inc.

K number K230980

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KGN 2023-08-24

Maxiocel Chitosan Wound Dressing

Applicant Advamedica, Inc.

K number K212766

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KGN 2023-06-09

NovoGen Wound Matrix

Applicant Novabone Products, LLC

K number K220498

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KGN 2023-05-02

FortiShield (Biosynthetic Wound Matrix)

Applicant Organogenesis, Inc.

K number K212579

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KGN 2022-11-21

Miro3D Wound Matrix

Applicant Reprise Biomedical

K number K223257

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KGN 2022-09-29

InnovaBurn

Applicant Triad Life Sciences, Inc.

K number K213716

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KGN 2022-09-28

InnovaMatrix PD

Applicant Triad Life Sciences, Inc.

K number K211902

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KGN 2022-09-20

LUOFUCON Collagen Wound Dressing

Applicant Huizhou Foryou Medical Devices Co., Ltd.

K number K213598

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KGN 2022-08-18

Miro3D Wound Matrix

Applicant Reprise Biomedical, Inc.

K number K221520

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KGN 2022-08-11

Foundation Dermal Regeneration Scaffold (DRS) Solo

Applicant Bionova Medical, Inc.

K number K210949

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KGN 2022-07-14

PELNAC Meshed Bilayer Wound Matrix

Applicant Gunze Limited

K number K213498

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KGN 2022-07-01

PuraPly Micronized Wound Matrix (PuraPly MZ)

Applicant Organogenesis, Inc.

K number K220317

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KGN 2022-06-29

Kerecis Silicone

Applicant Kerecis Limited

K number K213231

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KGN 2022-05-31

Fibrillar Collagen Wound Dressing

Applicant Collagen Matrix, Inc.

K number K213341

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KGN 2022-04-28

Geistlich Wound Matrix PLUS

Applicant Geistlich Pharma AG

K number K213607

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KGN 2022-02-09

PELNAC Wound Matrix

Applicant Gunze Limited

K number K213573

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KGN 2021-12-15

Cellusheet, Cellufil

Applicant Human Biosciences, Inc.

K number K213092

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KGN 2021-10-08

INTEGRA Wound Matrix (Macro-Channels)

Applicant Integra LifeSciences Corporation

K number K210128

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KGN 2021-10-07

NeoMatriX Wound Matrix

Applicant Nextgen Biologics, Inc.

K number K210024

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KGN 2021-04-21

InnovaMatrix FS

Applicant Triad Life Sciences, Inc.

K number K210580

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KGN 2021-03-31

Myriad Particles

Applicant Aroa Biosurgery , Ltd.

K number K200502

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KGN 2021-01-07

MatriDerm

Applicant Medskin Solutions Dr. Suwelack AG

K number K201577

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KGN 2020-10-21

InnovaMatrix

Applicant Triad Life Sciences, Inc.

K number K193552

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KGN 2020-07-29

Symphony

Applicant Aroa Biosurgery , Ltd.

K number K200413

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KGN 2020-07-16

KeraStat Cream

Applicant Keranetics

K number K192386

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KGN 2020-04-29

PELNAC Bilayer Wound Matrix

Applicant Gunze Limited

K number K191992

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KGN 2020-02-28

scaffolene CL100 Bioresorbable Collagen Matrix

Applicant Freudenberg Technology Innovation SE & Co. KG

K number K192346

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KGN 2019-10-25

Cytal Wound Matrix 3-Layer

Applicant Acell, Inc.

K number K192725

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KGN 2019-07-10

MariGen Wound Extra

Applicant Kerecis Limited

K number K190528

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KGN 2019-01-17

ProgenaMatrix

Applicant Cell Constructs I, LLC

K number K182010

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KGN 2018-11-08

Geistlich Derma-Gide

Applicant Geistlich Pharma AG

K number K182838

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KGN 2018-10-11

NeoMatriX Wound Matrix

Applicant Nextgen Biologics, Inc.

K number K181330

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KGN 2018-05-25

SURECELL Gelling Fiber Wound Dressing

Applicant Jiangsu Newvalue Medical Producst Co.,Ltd

K number K173005

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KGN 2018-05-11

Cytal Wound Particulate

Applicant Acell, Inc.

K number K180776

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KGN 2018-03-16

XCelliStem Wound Powder

Applicant Stemsys

K number K172593

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KGN 2018-03-02

ologen Collagen Matrix

Applicant Aeon Astron Europe B.V.

K number K173223

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KGN 2017-12-07

gel-e Bandage

Applicant Gel-E, Inc. (Formerly Remedium Technologies, Inc.)

K number K172010

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KGN 2017-11-03

Geistlich Wound Matrix

Applicant Geistlich Pharma AG

K number K171842

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KGN 2017-10-06

MicroMatrix

Applicant Acell, Inc.

K number K172399

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KGN 2017-07-25

CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing 1 gram vial, CoMatryx Collagen Wound Dressing 10 gram bottle

Applicant Strukmyer Medical

K number K171645

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KGN 2017-06-14

Endoform Topical Matrix

Applicant Aroa Biosurgery

K number K171231

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KGN 2017-06-02

KeraStat(R) Gel

Applicant Keranetics, LLC

K number K162759

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KGN 2017-05-10

ABCcolla Collagen Matrix

Applicant Acro Biomedical Co., Ltd.

K number K162348

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KGN 2016-09-28

Flowable Wound Matrix

Applicant Cook Biotech Incorporated

K number K160136

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KGN 2016-06-23

Collagen Dental Wound Dressings

Applicant Collagen Matrix, Inc.

K number K152600

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KGN 2016-03-14

MicroMatrix

Applicant Acell, Inc.

K number K153754

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KGN 2016-02-22

PriMatrix Dermal Repair Scaffold

Applicant Tei Biosciences, Inc.

K number K153690

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KGN 2013-10-23

MARIGEN WOUND DRESSING

Applicant Kerecis Limited

K number K132343

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KGN 2013-08-16

COVAGEN

Applicant Covalon Technologies, Ltd.

K number K123756

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KGN 2013-08-05

PRIMATRIX DERMAL REPAIR SCAFFOLD

Applicant Tei Biosciences, Inc.

K number K131286

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KGN 2013-04-21

FIBRILLAR COLLAGEN WOUND DRESSING

Applicant Collafirm, LLC

K number K120250

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KGN 2013-04-05

SENTREX BIOSPONGE MPD

Applicant Bionova Medical, Inc.

K number K123961

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KGN 2013-02-26

BRIDGE EXTRACELLULAR COLLEGEN MATRIX

Applicant Harbor Medtech, Inc.

K number K122502

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KGN 2012-11-01

COLLAGEN DENTAL WOUND DRESSINGS

Applicant Collagen Matrix, Inc.

K number K122115

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KGN 2012-10-26

SKINTEMP II

Applicant Human Biosciences, Inc.

K number K122325

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KGN 2012-06-21

PROCOLL

Applicant Innocoll Pharmaceuticals

K number K120339

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KGN 2012-06-05

HEALEX BIOSPONGE WOUND DRESSING

Applicant Bionova Medical, Inc.

K number K112191

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KGN 2012-06-01

COLLAGEN WOUND DRESSING

Applicant Dalim Tissen Co., Ltd.

K number K112580

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KGN 2012-03-23

PORCINE DERMAL XENOGRAFTS PORCINE DERMAL MATRIX

Applicant Brennen Medical, LLC

K number K113866

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