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)
Top companies in KGN
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 15, 2026 | Integra LifeSciences Corp. (NeuroSciences) Cytal Burn Matrix 10x15 cm. Product ID: BMM1015. Open, Classified |
KGN | K152721 |
| Apr 15, 2026 | Integra LifeSciences Corp. (NeuroSciences) Cytal Burn Matrix 7x10 cm. Product ID: BMM0710. Open, Classified |
KGN | K152721 |
| Apr 15, 2026 | Integra LifeSciences Corp. (NeuroSciences) Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015. Open, Classified |
KGN | K152721 |
| Apr 15, 2026 | Integra LifeSciences Corp. (NeuroSciences) Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710. Open, Classified |
KGN | K152721 |
| Apr 15, 2026 | Integra LifeSciences Corp. (NeuroSciences) Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505. Open, Classified |
KGN | K152721 |
| Mar 27, 2026 | Medline 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 |
KGN | K060456 |
| Sep 30, 2024 | TEI 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 |
KGN | K100261 |
| Sep 30, 2024 | TEI 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 |
KGN | K100261 |
| Sep 30, 2024 | TEI 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 |
KGN | K100261 |
| Sep 30, 2024 | TEI 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 |
KGN | K153690 |
| Sep 30, 2024 | TEI 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 |
KGN | K153690 |
| Sep 30, 2024 | TEI 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 |
KGN | K153690 |
| Sep 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office DERMARITE INDUSTRIES DermaCol 100 Collagen Powder DermaCol 100 Collagen 1 Gram Model Number: 00300E Open, Classified |
KGN | K171645 |
| Sep 23, 2022 | Collagen 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 |
KGN | K152600 |
| Apr 18, 2022 | ProgenaCare 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 |
KGN | K182010 |
| May 28, 2021 | Southwest Technologies Inc Stimulen Collagen Moisturizing Lotion, ST9555B Open, Classified |
KGN | K030774 |
| Mar 31, 2019 | Integra 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 |
KGN | K072113 |
| Mar 26, 2019 | Molnlycke 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 |
KGN | K935189 |
| Nov 2, 2018 | AROA 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 |
KGN | K092096 |
| Nov 2, 2018 | AROA 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 |
KGN | K092096 |
| Nov 2, 2018 | AROA 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 |
KGN | K092096 |
| Jun 15, 2017 | TEI 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 |
KGN | K153690 |
| Apr 16, 2015 | Integra 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 |
KGN | None listed |
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