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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 2012-02-10

MESO WOUND MATRIX

Applicant Kensey Nash Corporation

K number K112888

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KGN 2012-02-09

INTEGRA WOUND MATRIX (THIN)

Applicant Integra LifeSciences Corporation

K number K113104

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KGN 2011-10-03

EXCELLAGEN

Applicant Tissue Repair Company

K number K110318

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KGN 2011-09-14

COLLAGEN POWDER

Applicant Innocoll Pharmaceuticals, Ltd.

K number K103648

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KGN 2011-09-07

UNITE BIOMATRIX

Applicant Synovis Orthopedic & Woundcare

K number K112399

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KGN 2011-08-29

MATRISTEM WOUND MATRIX

Applicant Acell, Inc.

K number K112409

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KGN 2011-08-09

COLLACARE DENTAL

Applicant Innocoll Pharmaceuticals, Ltd.

K number K110388

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KGN 2011-05-20

CORELEADER COLLA-PAD MODEL CS 03030

Applicant Coreleader Biotech Co., Ltd.

K number K102946

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KGN 2011-02-02

SURGIAID

Applicant Maxigen Biotech, Inc.

K number K100927

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KGN 2010-10-28

COLLEXA

Applicant Innocoll Pharmaceuticals

K number K100574

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KGN 2010-06-23

ENDOFORM DENTAL TEMPLATE

Applicant Mesynthes, Ltd.

K number K101546

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KGN 2010-02-16

COLLAGEN SPONGE

Applicant Innocoll Pharmaceuticals

K number K092805

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KGN 2010-01-21

ENDOFORM DERMAL TEMPLATE

Applicant Mesynthes, Ltd.

K number K092096

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KGN 2009-10-28

ACELL MATRISTEM WOUND SHEET

Applicant Acell, Inc.

K number K092926

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KGN 2009-10-22

THERAFORM BILAYER

Applicant Sewon Cellontech Co., Ltd.

K number K090823

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KGN 2009-08-26

COLLASORB COLLAGEN WOUND DRESSING

Applicant Hartmann-Conco, Inc.

K number K091338

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KGN 2009-07-30

ATLAS WOUND MATRIX

Applicant Wrightmedicaltechnologyinc

K number K090954

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KGN 2009-07-30

THERAFORM STANDARD/SHEET

Applicant Sewon Cellontech Co., Ltd.

K number K090812

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KGN 2009-06-25

COLLAWOUND WOUND DRESSING

Applicant Collamatrix Co., Inc.

K number K090894

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KGN 2009-05-14

AONGEN COLLAGEN MATRIX

Applicant Aeon Astron Europe B.V.

K number K080868

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KGN 2009-02-06

AWBAT-S, AWBAT-D, AWBAT-M

Applicant Aubrey, Inc.

K number K082869

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KGN 2008-12-12

PRIMATRIX DERMAL REPAIR SCAFFOLD

Applicant Tei Biosciences, Inc.

K number K083440

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KGN 2008-12-04

INTEGRA MESHED BILAYER WOUND MATRIX

Applicant Integra Lifesciences Corp.

K number K081635

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KGN 2008-10-30

HYDROLYZED COLLAGEN WITH 10% CHONDROITIN SULFATE (PSGAG, POLYSULFATED GLYCOSAMINOGLYCAN) WOUND GEL

Applicant Applied Nutritionals

K number K081724

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KGN 2008-10-08

LTM WOUND DRESSING

Applicant Lifecell Corp.

K number K082103

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KGN 2008-09-30

COLLIEVA

Applicant Innocoll Pharmaceuticals

K number K081782

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KGN 2008-03-14

NOCC HYDROPHILIC WOUND DRESSING

Applicant Kytogenics, Inc.

K number K080010

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KGN 2007-10-10

INTEGRA FLOWABLE WOUND MATRIX, MODEL FWD301

Applicant Integra Lifesciences Corp.

K number K072113

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KGN 2007-06-20

UNITE BIOMATRIX

Applicant Pegasus Biologics, Inc.

K number K071425

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KGN 2007-03-02

MODIFICATION TO COLLAWOUND DRESSING

Applicant Collamatrix Co., Inc.

K number K070269

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KGN 2006-10-02

COLLAGUARD, MODEL FCIA,FCIB,FCIC,AND FCID

Applicant Innocoll Pharmaceuticals

K number K061746

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KGN 2006-09-21

DERMADAPT WOUND DRESSING

Applicant Pegasus Biologics, Inc.

K number K061494

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KGN 2006-07-19

OASIS WOUND MATRIX

Applicant Cook Biotech, Inc.

K number K061711

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KGN 2006-07-05

COLLAWOUND DRESSING

Applicant Collamatrix Co., Inc.

K number K061474

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KGN 2006-06-29

PRIMATRIX DERMAL REPAIR SCAFFOLD

Applicant Tei Biosciences, Inc.

K number K061407

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KGN 2006-06-23

ACELL POWDER WOUND DRESSING

Applicant Acell, Inc.

K number K060888

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KGN 2006-06-19

MEDLINE COLLAGEN WOUND DRESSING

Applicant Medline Industries, Inc.

K number K060456

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KGN 2005-04-27

COLACTIVE COLLAGEN WOUND DRESSING

Applicant Covalontechnologies, Inc.

K number K050177

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KGN 2004-08-12

HEALICOLL

Applicant Encoll Corp.

K number K040314

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KGN 2004-08-09

STIMULEN COLLAGEN

Applicant Southwest Technologies, Inc.

K number K030774

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KGN 2004-05-10

COLLAGEN WOUND DRESSING - ORAL

Applicant Collagen Matrix, Inc.

K number K040403

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KGN 2004-03-17

MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING

Applicant Collagen Matrix, Inc.

K number K040558

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KGN 2004-02-27

MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING

Applicant Collagen Matrix, Inc.

K number K040211

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KGN 2003-09-29

DRESSSKIN

Applicant Tei Biosciences, Inc.

K number K023778

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KGN 2003-05-15

COLLAGEN TOPICAL WOUND DRESSING

Applicant Collagen Matrix, Inc.

K number K030921

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KGN 2002-12-30

ACELL UBM HYDRATED WOUND DRESSING

Applicant Acell, Inc.

K number K022854

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KGN 2002-12-19

ACELL UBM LYOPHILIZED WOUND DRESSING

Applicant Acell, Inc.

K number K021637

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KGN 2002-09-10

AVAGEN WOUND DRESSING

Applicant Integra Lifesciences Corp.

K number K022127

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KGN 2002-08-14

BILAYER MATRIX WOUND DRESSING

Applicant Integra Lifesciences Corp.

K number K021792

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KGN 2002-05-30

SS MATRIX

Applicant Cook Biotech, Inc.

K number K020732

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KGN 2002-02-14

PROMOGRAN MATRIX WOUND DRESSING

Applicant Johnson & Johnson Medical, Ltd.

K number K014129

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KGN 2001-10-24

COLLATEK POWDER

Applicant Biocore Medical Technologies, Inc.

K number K012990

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KGN 2001-06-13

FORTADERM WOUND DRESSING

Applicant Organogenesis, Inc.

K number K011026

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KGN 2000-12-22

FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING

Applicant Adri/Technam

K number K003134

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KGN 2000-10-18

COLLAGEN WOUND DRESSING

Applicant Oasis Research, LLC

K number K002443

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KGN 2000-04-18

MEDTRADE PRODUCTS ALGINATE ISLAND

Applicant Medtrade Products , Ltd.

K number K000487

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KGN 2000-03-22

HYCURE ORAL / HYCURE ORAL SMART GEL

Applicant The Hymed Group Corp.

K number K994339

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KGN 2000-03-13

FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN

Applicant Adri

K number K000054

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KGN 2000-01-06

SIS WOUND DRESSING II

Applicant Cook Biotech, Inc.

K number K993948

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KGN 1999-05-18

SIGNADRESS DUODERM DRESSING

Applicant Convatec, A Division of E.R. Squibb & Sons

K number K990964

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KGN 1999-03-31

HELIDERM COLLAGEN WOUND DRESSINGS 0.5 GRAM AND 1.0 GRAM

Applicant Integra Lifesciences Corp.

K number K990086

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KGN 1999-03-03

HA ABSORBENT WOUND DRESSING

Applicant Convatec, A Division of E.R. Squibb & Sons

K number K984388

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KGN 1998-08-20

FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE

Applicant Johnson & Johnson Medical, Inc.

K number K982597

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KGN 1998-04-30

SIS WOUND DRESSING

Applicant Cook Biotech, Inc.

K number K973170

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KGN 1997-04-23

KENDALL HYDROPHILIC POWDER WOUND DRESSING

Applicant Kendall Healthcare Products Co. Div.Of Tyco Health

K number K970266

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KGN 1996-12-18

REPLIDERM WOUND DRESSING

Applicant Orphan Medical, Inc.

K number K963228

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KGN 1996-01-17

HYCURE

Applicant The Hymed Group Corp.

K number K955506

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KGN 1995-06-28

MEDISKIN(R) SS, ZENODERM BIOLOGICAL WOUND DRESSING

Applicant Brennen Medical, Inc.

K number K950032

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KGN 1995-04-13

MESH MATRIX WOUND DRESSING

Applicant Brennen Medical, Inc.

K number K950281

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KGN 1994-07-11

E-Z DERM BIOSYNTHETIC WOUND DRESSING

Applicant Brennen Medical, Inc.

K number K935189

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KGN 1993-02-23

SKINTEMP, MODIFICATION

Applicant Biocore

K number K925545

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KGN 1991-12-04

VIADERM

Applicant Abs Life Sciences

K number K914024

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KGN 1991-10-02

SKINTEMP

Applicant Biocore

K number K913023

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KGN 1991-04-02

MEDIFIL

Applicant Biocore

K number K910944

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KGN 1990-06-05

GREEN LABEL BIOBRANE II AND RED LABEL BIOBRANE II

Applicant Sterling Drug, Inc.

K number K901369

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KGN 1989-11-28

BIOBRANE(R) II

Applicant Sterling Drug, Inc.

K number K896110

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KGN 1989-10-16

COPOLYESTER FILM DRESSING

Applicant Tri-State Hospital Supply Corp.

K number K893647

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KGN 1988-10-07

VIADERM

Applicant Applied Biomedical Sciences

K number K882590

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KGN 1984-11-07

CUSTOM BURN DRESSING KIT

Applicant Hermitage Hospital Products, Inc.

K number K843788

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KGN 1979-05-03

BIOBRANE BRAND TEMPORARY WOUND DRESSING

Applicant Woodroof Laboratories, Inc.

K number K790496

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