Atlas FDA

KGN

190 FDA 510(k) clearances · Product code

121 daysmedian time to decision
306 days90th percentile
190clearances measured

FDA profile

Official device name
Wound Dressing With Animal-Derived Material(S)
Device class
Unclassified
Medical specialty
Unknown
Flags
Implant
Adverse events (MAUDE)
2015: 9 · 2018: 15 · 2020: 17 · 2021: 14 · 2022: 13 · 2023: 21
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Collagen Wound Powder (K260596)Ventris Medical2026-07-02
Endoform Dermal Template (K260669)Aroa Biosurgery , Ltd.2026-06-24
ECMT-100 WMD (K253521)Ecm Therapeutics, Inc.2026-06-18
Catalyze (K253204)BioTissue Holdings, Inc.2026-06-05
Roosin Collagen Dressing (K253974)Roosin Medical Co., Ltd.2026-06-03
Roosin Collagen Powder (K254034)Roosin Medical Co., Ltd.2026-06-03
MatriDerm (K261224)Medskin Solutions Dr. Suwelack AG2026-05-14
Derma-Gide (K260532)Geistlich Pharma AG2026-03-19
LacertaMatrix (K260218)Lacerta Life Sciences2026-02-19
CollOvine™ Wound Powder (K253140)Ovigenex, LLC2026-02-10
Device 104 Particulate (K251323)Geistlich Pharma AG2026-01-22
Theracor (K253339)Stimlabs, LLC2025-12-22
LacertaMatrix (K252673)Lacerta Life Science2025-12-22
MatriDerm pluS+ Bi-Layer (K250864)Medskin Solutions Dr. Suwelack AG2025-12-19
SurgiAid Collagen Wound Dressing (HA) (K242100)Maxigen Biotech, Inc.2025-10-16
Collagen Wound Dressing (K252001)Winner Medical Co., Ltd.2025-10-10
Helios Dermal Scaffold (K250397)Helios Biomedical, Inc.2025-08-15
Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus (K251845)Kerecis Limited2025-07-16
GeniPhys Collymer Self-Assembling Scaffold (K250329)Geniphys, Inc.2025-06-25
CollOvine™ Wound Dressing (K242985)Ovigenex, LLC2025-06-20
DermiSphere Dermal Template (K241904)Fesariustherapeutics, Inc.2025-01-06
Bovine Dermis Collagen Dermal Matrix (K243071)Collagen Matrix, Inc.2024-12-19
BIOBRANE Temporary Wound Dressing; BIOBRANE Glove (K242146)Smith & Nephew Medical Limited2024-12-17
Corplex P/ Theracor P/ Allacor P (K242828)Stimlabs, LLC2024-10-18
ABCcolla® Collagen ADM Scaffold (K233378)Acro Biomedical Co., Ltd.2024-10-18
Kerecis Parvus (50207) (K241080)Kerecis Limited2024-08-21
InnovaMatrix®FD (K241866)Convatec Triad Life Sciences, LLC2024-07-26
Cytal® Wound Matrix; Cytal® Burn Matrix (K241724)Acell, Inc.2024-07-11
MicroMatrix® UBM Particulate (K241706)Acell, Inc.2024-07-11
LUOFUCON® Collagen Particles (Collagen Wound Dressing) (K232796)Huizhou Foryou Medical Devices Co., Ltd.2024-04-25
ReyaGel (RG03 - MTP gel 3mL) (K232204)Fettech2024-04-19
Miro3D Fibers Wound Matrix (K240753)Reprise Biomedical, Inc.2024-04-19
MiroDry Wound Matrix (K240277)Reprise Biomedical, Inc.2024-03-01
Corplex P / Theracor P / Allacor P (K231325)Stimlabs, LLC2024-02-02
MiroTract Wound Matrix (K231614)Reprise Biomedical, Inc.2023-12-13
Comatryx OTC (K232758)Strukmyer Medical, LLC2023-12-01
Foundation Dermal Regeneration Scaffold (DRS) Solo (K231937)Bionova Medical, Inc.2023-11-13
Collagen Wound Dressing (K231152)Winner Medical Co., Ltd.2023-10-12
SurgiAid® Collagen Wound Dressing (K223126)Maxigen Biotech, Inc.2023-10-11
MicroMatrix® Flex (K230980)Acell, Inc.2023-09-22
Maxiocel Chitosan Wound Dressing (K212766)Advamedica, Inc.2023-08-24
NovoGen Wound Matrix (K220498)Novabone Products, LLC2023-06-09
FortiShield (Biosynthetic Wound Matrix) (K212579)Organogenesis, Inc.2023-05-02
Miro3D Wound Matrix (K223257)Reprise Biomedical2022-11-21
InnovaBurn (K213716)Triad Life Sciences, Inc.2022-09-29
InnovaMatrix PD (K211902)Triad Life Sciences, Inc.2022-09-28
LUOFUCON Collagen Wound Dressing (K213598)Huizhou Foryou Medical Devices Co., Ltd.2022-09-20
Miro3D Wound Matrix (K221520)Reprise Biomedical, Inc.2022-08-18
Foundation Dermal Regeneration Scaffold (DRS) Solo (K210949)Bionova Medical, Inc.2022-08-11
PELNAC Meshed Bilayer Wound Matrix (K213498)Gunze Limited2022-07-14
PuraPly Micronized Wound Matrix (PuraPly MZ) (K220317)Organogenesis, Inc.2022-07-01
Kerecis Silicone (K213231)Kerecis Limited2022-06-29
Fibrillar Collagen Wound Dressing (K213341)Collagen Matrix, Inc.2022-05-31
Geistlich Wound Matrix PLUS (K213607)Geistlich Pharma AG2022-04-28
PELNAC Wound Matrix (K213573)Gunze Limited2022-02-09
Cellusheet, Cellufil (K213092)Human Biosciences, Inc.2021-12-15
INTEGRA Wound Matrix (Macro-Channels) (K210128)Integra LifeSciences Corporation2021-10-08
NeoMatriX Wound Matrix (K210024)Nextgen Biologics, Inc.2021-10-07
InnovaMatrix FS (K210580)Triad Life Sciences, Inc.2021-04-21
Myriad Particles (K200502)Aroa Biosurgery , Ltd.2021-03-31
MatriDerm (K201577)Medskin Solutions Dr. Suwelack AG2021-01-07
InnovaMatrix (K193552)Triad Life Sciences, Inc.2020-10-21
Symphony (K200413)Aroa Biosurgery , Ltd.2020-07-29
KeraStat Cream (K192386)Keranetics2020-07-16
PELNAC Bilayer Wound Matrix (K191992)Gunze Limited2020-04-29
scaffolene CL100 Bioresorbable Collagen Matrix (K192346)Freudenberg Technology Innovation SE & Co. KG2020-02-28
Cytal Wound Matrix 3-Layer (K192725)Acell, Inc.2019-10-25
MariGen Wound Extra (K190528)Kerecis Limited2019-07-10
ProgenaMatrix (K182010)Cell Constructs I, LLC2019-01-17
Geistlich Derma-Gide (K182838)Geistlich Pharma AG2018-11-08
NeoMatriX Wound Matrix (K181330)Nextgen Biologics, Inc.2018-10-11
SURECELL Gelling Fiber Wound Dressing (K173005)Jiangsu Newvalue Medical Producst Co.,Ltd2018-05-25
Cytal Wound Particulate (K180776)Acell, Inc.2018-05-11
XCelliStem Wound Powder (K172593)Stemsys2018-03-16
ologen Collagen Matrix (K173223)Aeon Astron Europe B.V.2018-03-02
gel-e Bandage (K172010)Gel-E, Inc. (Formerly Remedium Technologies, Inc.)2017-12-07
Geistlich Wound Matrix (K171842)Geistlich Pharma AG2017-11-03
MicroMatrix (K172399)Acell, Inc.2017-10-06
CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing 1 gram vial, CoMatryx Collagen Wound Dressing 10 gram bottle (K171645)Strukmyer Medical2017-07-25
Endoform Topical Matrix (K171231)Aroa Biosurgery2017-06-14
KeraStat(R) Gel (K162759)Keranetics, LLC2017-06-02
ABCcolla Collagen Matrix (K162348)Acro Biomedical Co., Ltd.2017-05-10
Flowable Wound Matrix (K160136)Cook Biotech Incorporated2016-09-28
Collagen Dental Wound Dressings (K152600)Collagen Matrix, Inc.2016-06-23
MicroMatrix (K153754)Acell, Inc.2016-03-14
PriMatrix Dermal Repair Scaffold (K153690)Tei Biosciences, Inc.2016-02-22
Cytal Wound Matrix (K152721)Acell, Inc.2015-12-08
Cook ECM Powder (K152033)Cook Biotech Incorporated2015-08-19
XENOMEM WOUND MATRIX (K140820)Viscus Biologics, LLC2015-06-26
MEDEOR MATRIX WOUND DRESSING (K141738)Kensey Nash Corporation Dba Dsm Biomedical2015-02-17
Wound Matrix TF (K143426)Miromatrix Medical, Inc.2015-01-27
KA01 Chitosan Wound Dressing (K143124)Foshan United Medical Technologies, Ltd.2015-01-26
Dental Collagen Wound Dressing (Nova Tape and NovaPlug) (K142712)Novabone Products, LLC2015-01-08
ARCHITECT PX EXTRACELLULAR COLLAGEN MATRIX (K140367)Harbor Medtech, Inc.2014-09-12
PREMVIA (K134037)Biotime, Inc.2014-08-07
BIO-CONNEKT WOUND MATRIX (K140456)MLM Biologics, Inc.2014-07-22
MIROMATRIX WOUND MATRIX (K140510)Miromatrix Medical, Inc.2014-06-19
COLLACARE DENTAL (K133290)Innocoll Pharmaceuticals2014-05-01
MARIGEN WOUND DRESSING (K132343)Kerecis Limited2013-10-23
COVAGEN (K123756)Covalon Technologies, Ltd.2013-08-16
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Every clearance here is in the API, with alerts when new ones post.