ClearanceBrief
Product code KGN ยท 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

DateFirm and productCodeLinked 510(k)
Apr 15, 2026Integra LifeSciences Corp. (NeuroSciences)
Cytal Burn Matrix 10x15 cm. Product ID: BMM1015.
Open, Classified
KGNK152721
Apr 15, 2026Integra LifeSciences Corp. (NeuroSciences)
Cytal Burn Matrix 7x10 cm. Product ID: BMM0710.
Open, Classified
KGNK152721
Apr 15, 2026Integra LifeSciences Corp. (NeuroSciences)
Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.
Open, Classified
KGNK152721
Apr 15, 2026Integra LifeSciences Corp. (NeuroSciences)
Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.
Open, Classified
KGNK152721
Apr 15, 2026Integra LifeSciences Corp. (NeuroSciences)
Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.
Open, Classified
KGNK152721
Mar 27, 2026Medline Industries, LP
Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP DRESSING,COLLAGEN,PURACOL PLUS, 2X2.2"
Open, Classified
KGNK060456
Sep 30, 2024TEI Biosciences, Inc.
PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm (2:1), 10x25 cm (2:1), 20x25 cm (1:1), 4x4 cm (2:1), 6x6 cm (2:1), 8x12 cm (2:1), 8x8 cm (2:1).
Open, Classified
KGNK100261
Sep 30, 2024TEI Biosciences, Inc.
PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.
Open, Classified
KGNK100261
Sep 30, 2024TEI Biosciences, Inc.
PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.
Open, Classified
KGNK100261
Sep 30, 2024TEI Biosciences, Inc.
PriMatrix Meshed; Dermal Repair Scaffold; Rx Only; Sizes 20x25 cm (1:1), 3x3 cm (2:1), 4x4 cm (2:1), 5x5 cm (2:1), 6x6 cm (2:1), 8x12 cm (2:1), and 8x8 cm (2:1).
Open, Classified
KGNK153690
Sep 30, 2024TEI Biosciences, Inc.
PriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm, 8x8 cm, 14mm Disc, 18mm Disc, 2x2 cm, and 10x25 cm (Meshed 2:1).
Open, Classified
KGNK153690
Sep 30, 2024TEI Biosciences, Inc.
PriMatrix; Dermal Repair Scaffold; Rx Only; Sizes 0.2x26.5 cm (3 pack), 10x12cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, and 8x8 cm.
Open, Classified
KGNK153690
Sep 26, 2022Mckesson Medical-Surgical Inc. Corporate Office
DERMARITE INDUSTRIES DermaCol 100 Collagen Powder DermaCol 100 Collagen 1 Gram Model Number: 00300E
Open, Classified
KGNK171645
Sep 23, 2022Collagen Matrix Inc
Collagen Dental Wound Dressing - Bovine Dermis Tap, 25mm x 75mm Product was distributed under the following brand names: 1) Cytoplast RTMTAPE, 25mm x 75mm 2) GIBSON Healthcare, 25mm x 75mm 3) Maxx
Open, Classified
KGNK152600
Apr 18, 2022ProgenaCare
progenamatrix Human Keratin Matrix, sterile, Rx, with the following model numbers: (1) PM2012, 12 x 2 cm; (2) PM3002, 2 x 2 cm; (3) PM3004, 4 x 4 cm; PM3006, 6 x 6 cm; and PM3010, 10 x 10 cm.
Terminated
KGNK182010
May 28, 2021Southwest Technologies Inc
Stimulen Collagen Moisturizing Lotion, ST9555B
Open, Classified
KGNK030774
Mar 31, 2019Integra Limited
Integra Flowable Wound Matrix Catalog No: FWD301 Product Usage: Integra Flowable Wound Matrix is indicated for the treatment of tunneling and/or undermined wounds including: surgical wounds (donor si
Terminated
KGNK072113
Mar 26, 2019Molnlycke Health Care, Inc
EZ Derm Porcine Xenograft, labeled as the following: a. EZ Derm 3x4 (8x10 cm) Non-Perforated, Part Number: 131703-03; b. EZ Derm 7 x 18 (17 x 46 cm) Non-Perforated, Part Number: 131704-03; c.
Terminated
KGNK935189
Nov 2, 2018AROA BIOSURGERY
Endoform Dermal Template 4x5, SKU 529313 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular matrix intended to cover, protect and provide a moist
Terminated
KGNK092096
Nov 2, 2018AROA BIOSURGERY
Endoform Dermal Template 2x2, SKU 529312 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular matrix intended to cover, protect and provide a moist
Terminated
KGNK092096
Nov 2, 2018AROA BIOSURGERY
Endoform Dermal Template 2x2, SKU 529311 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular matrix intended to cover, protect and provide a moist
Terminated
KGNK092096
Jun 15, 2017TEI Biosciences
PriMatrix is an acellular dermal tissue matrix derived from fetal bovine dermis. The device is supplied sterile in a variety of sizes to be trimmed by the surgeon to meet the individual patient's need
Terminated
KGNK153690
Apr 16, 2015Integra LifeSciences Corp.
Integra Flowable Wound Matrix Size 3cc 1 unit/box single use, sterile device Rx Only Model Number FWD301 (US) & FDR301 (Non-US) Flowable Wound Matrix is comprised of the following components which
Terminated
KGNNone listed

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