Medical Device Manufacturer · IS , Isafjordur

Kerecis Limited

10 submissions · 10 cleared · Since 2013
10
Total
10
Cleared
0
Denied

Kerecis Limited — FDA 510(k) Submissions

Kerecis Limited has submitted 10 FDA 510(k) premarket notifications since 2013, of which 10 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Wound Dressing With Animal-derived Material(s), Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery, Mesh, Surgical, Collagen, Staple Line Reinforcement, Barrier, Animal Source, Intraoral, Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon . Use the specialty filter in the sidebar to narrow results.

10 devices
1–10 of 10
Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus
K251845 · KGN Wound Dressing With... · General & Plastic Surgery
Jul 2025 30d
Kerecis SurgiBind (50241)
K251844 · OXH Mesh, Surgical, Collagen,... · General & Plastic Surgery
Jul 2025 29d
Tendon Protect (50242)
K243843 · OWY Mesh, Surgical, Collagen,... · Orthopedic
Jun 2025 173d
Kerecis Parvus (50207)
K241080 · KGN Wound Dressing With... · General & Plastic Surgery
Aug 2024 124d
Kerecis Silicone
K213231 · KGN Wound Dressing With... · General & Plastic Surgery
Jun 2022 272d
Kerecis Reconstruct
K202430 · OXH Mesh, Surgical, Collagen,... · General & Plastic Surgery
May 2021 250d
Kerecis Gingiva Graft
K192612 · NPL Barrier, Animal Source,... · Dental
Nov 2020 420d
MariGen Wound Extra
K190528 · KGN Wound Dressing With... · General & Plastic Surgery
Jul 2019 128d
Kerecis SecureMesh
K153364 · OXE Mesh, Surgical, Collagen,... · General & Plastic Surgery
Aug 2016 273d
MARIGEN WOUND DRESSING
K132343 · KGN Wound Dressing With... · General & Plastic Surgery
Oct 2013 85d
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