ClearanceBrief
Company ยท IS

Kerecis Limited

FDA 510(k) clearances and medical device recalls filed under this name, 2013 to 2025. Name variants (Inc, Corp, punctuation) are merged.

11510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
KGNWound Dressing With Animal-Derived Material(S)5
NPLBarrier, Animal Source, Intraoral2
OXHMesh, Surgical, Collagen, Plastic And Reconstructive Surgery2
OWYMesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon1
OXEMesh, Surgical, Collagen, Staple Line Reinforcement1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jul 16, 2025K251845Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus
Kerecis Limited, IS
KGN
Jul 15, 2025K251844Kerecis SurgiBind (50241)
Kerecis Limited, IS
OXH
Jun 4, 2025K243843Tendon Protect (50242)
Kerecis Limited, IS
OWY
Aug 21, 2024K241080Kerecis Parvus (50207)
Kerecis Limited, IS
KGN
Sep 30, 2022K213904Kerecis Oral
Kerecis, IS
NPL
Jun 29, 2022K213231Kerecis Silicone
Kerecis Limited, IS
KGN
May 2, 2021K202430Kerecis Reconstruct
Kerecis Limited, IS
OXH
Nov 13, 2020K192612Kerecis Gingiva Graft
Kerecis Limited, IS
NPL
Jul 10, 2019K190528MariGen Wound Extra
Kerecis Limited, IS
KGN
Aug 19, 2016K153364Kerecis SecureMesh
Kerecis Limited, IS
OXE
Oct 23, 2013K132343MARIGEN WOUND DRESSING
Kerecis Limited, IS
KGN

Latest recalls

DateFirm and productCodeLinked 510(k)
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