Medical Device Manufacturer · IS , Isafjordur

Kerecis Limited - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 2013

10

Total

10

Cleared

0

Denied

FDA 510(k) cleared devices by Kerecis Limited General & Plastic Surgery ✕

8 devices

1-8 of 8

Cleared Jul 16, 2025

Marigen Wound Extra

General & Plastic Surgery · 30d

Cleared Jul 15, 2025

Kerecis SurgiBind (50241)

General & Plastic Surgery · 29d

Cleared Aug 21, 2024

Kerecis Parvus (50207)

General & Plastic Surgery · 124d

Cleared Jun 29, 2022

Kerecis Silicone

General & Plastic Surgery · 272d

Cleared May 02, 2021

Kerecis Reconstruct

General & Plastic Surgery · 250d

Cleared Jul 10, 2019

MariGen Wound Extra

General & Plastic Surgery · 128d

Cleared Aug 19, 2016

Kerecis SecureMesh

General & Plastic Surgery · 273d

Cleared Oct 23, 2013

MARIGEN WOUND DRESSING

General & Plastic Surgery · 85d