ClearanceBrief
Product code KGN · Class U

Wound Dressing With Animal-Derived Material(S)

18510(k)s in 12 months (194 all time)
6recalls in 12 months (23 all time)
22recalls that name a 510(k)
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Top companies in KGN

Company510(k)sRecalls
Acell, Inc.130
Tei Biosciences, Inc.57
Collagen Matrix, Inc.81
Innocoll Pharmaceuticals80
Integra LifeSciences Corporation71
Aroa Biosurgery43
Cook Biotech Incorporated60
Geistlich Pharma AG50
Integra LifeSciences Corp. (NeuroSciences)05
Kerecis Limited50
Decided510(k)Device and applicantCode
Oct 22, 2026K260920Accelagen Advanced Surgical Collagen Matrix, 1cc (CG-01AA); Accelagen Advanced Surgical Collagen Matrix, 2cc (CG-02AA);
Berkeley Advanced Biomaterials
KGN
Oct 15, 2026K260530epi-ConneKt™ Wound Matrix
MLM Biologics, Inc.
KGN
Sep 9, 2026K260652ColActive Plus
Covalon Technologies, Ltd., CA
KGN
Aug 27, 2026K260711Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP);Accelagen Plus Surgical Matr
Berkeley Advanced Biomaterials
KGN
Jul 2, 2026K260596Collagen Wound Powder
Ventris Medical
KGN
Jun 24, 2026K260669Endoform Dermal Template
Aroa Biosurgery , Ltd., NZ
KGN
Jun 18, 2026K253521ECMT-100 WMD
Ecm Therapeutics, Inc.
KGN
Jun 5, 2026K253204Catalyze
BioTissue Holdings, Inc.
KGN
Jun 3, 2026K254034Roosin Collagen Powder
Roosin Medical Co., Ltd., CN
KGN
Jun 3, 2026K253974Roosin Collagen Dressing
Roosin Medical Co., Ltd., CN
KGN
May 14, 2026K261224MatriDerm
Medskin Solutions Dr. Suwelack AG, DE
KGN
Mar 19, 2026K260532Derma-Gide
Geistlich Pharma AG, CH
KGN
Feb 19, 2026K260218LacertaMatrix
Lacerta Life Sciences
KGN
Feb 10, 2026K253140CollOvine™ Wound Powder
Ovigenex, LLC
KGN
Jan 22, 2026K251323Device 104 Particulate
Geistlich Pharma AG, CH
KGN
Dec 22, 2025K253339Theracor
Stimlabs, LLC
KGN
Dec 22, 2025K252673LacertaMatrix
Lacerta Life Science
KGN
Dec 19, 2025K250864MatriDerm pluS+ Bi-Layer
Medskin Solutions Dr. Suwelack AG, DE
KGN
Oct 16, 2025K242100SurgiAid Collagen Wound Dressing (HA)
Maxigen Biotech, Inc., TW
KGN
Oct 10, 2025K252001Collagen Wound Dressing
Winner Medical Co., Ltd., CN
KGN
Aug 15, 2025K250397Helios Dermal Scaffold
Helios Biomedical, Inc.
KGN
Jul 16, 2025K251845Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus
Kerecis Limited, IS
KGN
Jun 25, 2025K250329GeniPhys Collymer Self-Assembling Scaffold
Geniphys, Inc.
KGN
Jun 20, 2025K242985CollOvine™ Wound Dressing
Ovigenex, LLC
KGN
Jan 6, 2025K241904DermiSphere Dermal Template
Fesariustherapeutics, Inc.
KGN
Dec 19, 2024K243071Bovine Dermis Collagen Dermal Matrix
Collagen Matrix, Inc.
KGN
Dec 17, 2024K242146BIOBRANE Temporary Wound Dressing; BIOBRANE Glove
Smith & Nephew Medical Limited, GB
KGN
Oct 18, 2024K242828Corplex P/ Theracor P/ Allacor P
Stimlabs, LLC
KGN
Oct 18, 2024K233378ABCcolla® Collagen ADM Scaffold
Acro Biomedical Co., Ltd., TW
KGN
Aug 21, 2024K241080Kerecis Parvus (50207)
Kerecis Limited, IS
KGN
Jul 26, 2024K241866InnovaMatrix®FD
Convatec Triad Life Sciences, LLC
KGN
Jul 11, 2024K241724Cytal® Wound Matrix; Cytal® Burn Matrix
Acell, Inc.
KGN
Jul 11, 2024K241706MicroMatrix® UBM Particulate
Acell, Inc.
KGN
Apr 25, 2024K232796LUOFUCON® Collagen Particles (Collagen Wound Dressing)
Huizhou Foryou Medical Devices Co., Ltd., CN
KGN
Apr 19, 2024K240753Miro3D Fibers Wound Matrix
Reprise Biomedical, Inc.
KGN
Apr 19, 2024K232204ReyaGel (RG03 - MTP gel 3mL)
Fettech
KGN
Mar 1, 2024K240277MiroDry Wound Matrix
Reprise Biomedical, Inc.
KGN
Feb 2, 2024K231325Corplex P / Theracor P / Allacor P
Stimlabs, LLC
KGN
Dec 13, 2023K231614MiroTract Wound Matrix
Reprise Biomedical, Inc.
KGN
Dec 1, 2023K232758Comatryx OTC
Strukmyer Medical, LLC
KGN
Nov 13, 2023K231937Foundation Dermal Regeneration Scaffold (DRS) Solo
Bionova Medical, Inc.
KGN
Oct 12, 2023K231152Collagen Wound Dressing
Winner Medical Co., Ltd., CN
KGN
Oct 11, 2023K223126SurgiAid® Collagen Wound Dressing
Maxigen Biotech, Inc., TW
KGN
Sep 22, 2023K230980MicroMatrix® Flex
Acell, Inc.
KGN
Aug 24, 2023K212766Maxiocel Chitosan Wound Dressing
Advamedica, Inc.
KGN
Jun 9, 2023K220498NovoGen Wound Matrix
Novabone Products, LLC
KGN
May 2, 2023K212579FortiShield (Biosynthetic Wound Matrix)
Organogenesis, Inc.
KGN
Nov 21, 2022K223257Miro3D Wound Matrix
Reprise Biomedical
KGN
Sep 29, 2022K213716InnovaBurn
Triad Life Sciences, Inc.
KGN
Sep 28, 2022K211902InnovaMatrix PD
Triad Life Sciences, Inc.
KGN

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