FDA.reportPublic FDA data

Kerecis

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30132811273013281127Kerecis Arlington1Y2026-01-012101 Wilson Blvd Suite 900 Arlington VA US 22201
30164292463016429246KERECIS EHF1N2026-01-01Sundstraeti 38 Isafjordur Vestfiroir IS 400
30319765823031976582Kerecis Minneapolis1Y2026-01-011601 West River Road N Suite B117 Minneapolis MN US 55411

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
05694310969468MariGen® Compact - Wound management medical device product made from fish skin. Kerecis MariGen® Compact is indicated for the management of wounds including: Partial and full-thickness wounds, Pressure ulcers, Venous ulcers, Chronic vascular ulcers, Diabetic ulcers, Trauma wounds (abrasions, lacerations, partial thickness burns, skin tears), Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and Draining wounds. https://www.kerecis.com/ifus/ifu-kerecis-marigen-compact7032878752info@kerecis.com
05694310969482MariGen® Compact - Wound management medical device product made from fish skin. Kerecis MariGen® Compact is indicated for the management of wounds including: Partial and full-thickness wounds, Pressure ulcers, Venous ulcers, Chronic vascular ulcers, Diabetic ulcers, Trauma wounds (abrasions, lacerations, partial thickness burns, skin tears), Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and Draining wounds. https://www.kerecis.com/ifus/ifu-kerecis-marigen-compact7032878752info@kerecis.com
05694310969505MariGen® Compact - Wound management medical device product made from fish skin. Kerecis MariGen® Compact is indicated for the management of wounds including: Partial and full-thickness wounds, Pressure ulcers, Venous ulcers, Chronic vascular ulcers, Diabetic ulcers, Trauma wounds (abrasions, lacerations, partial thickness burns, skin tears), Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and Draining wounds. https://www.kerecis.com/ifus/ifu-kerecis-marigen-compact7032878752info@kerecis.com
05694310969529MariGen® Compact - Wound management medical device product made from fish skin. Kerecis MariGen® Compact is indicated for the management of wounds including: Partial and full-thickness wounds, Pressure ulcers, Venous ulcers, Chronic vascular ulcers, Diabetic ulcers, Trauma wounds (abrasions, lacerations, partial thickness burns, skin tears), Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and Draining wounds. https://www.kerecis.com/ifus/ifu-kerecis-marigen-compact7032878752info@kerecis.com
05694310969543SurgiClose® Compact - Wound management medical device product made from fish skin. Kerecis SurgiClose® Compact is indicated for the management of surgical wounds including: Partial and full-thickness wounds, Pressure ulcers, Venous ulcers, Chronic vascular ulcers, Diabetic ulcers, Trauma wounds (abrasions, lacerations, partial thickness burns, skin tears), Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and Draining wounds. https://www.kerecis.com/ifus/ifu-kerecis-surgiclose-compact7032878752info@kerecis.com
05694310969567SurgiClose® Compact - Wound management medical device product made from fish skin. Kerecis SurgiClose® Compact is indicated for the management of surgical wounds including: Partial and full-thickness wounds, Pressure ulcers, Venous ulcers, Chronic vascular ulcers, Diabetic ulcers, Trauma wounds (abrasions, lacerations, partial thickness burns, skin tears), Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and Draining wounds. https://www.kerecis.com/ifus/ifu-kerecis-surgiclose-compact7032878752info@kerecis.com
05694310969581SurgiClose® Compact - Wound management medical device product made from fish skin. Kerecis SurgiClose® Compact is indicated for the management of surgical wounds including: Partial and full-thickness wounds, Pressure ulcers, Venous ulcers, Chronic vascular ulcers, Diabetic ulcers, Trauma wounds (abrasions, lacerations, partial thickness burns, skin tears), Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and Draining wounds. https://www.kerecis.com/ifus/ifu-kerecis-surgiclose-compact7032878752info@kerecis.com
05694310969604SurgiClose® Compact - Wound management medical device product made from fish skin. Kerecis SurgiClose® Compact is indicated for the management of surgical wounds including: Partial and full-thickness wounds, Pressure ulcers, Venous ulcers, Chronic vascular ulcers, Diabetic ulcers, Trauma wounds (abrasions, lacerations, partial thickness burns, skin tears), Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and Draining wounds. https://www.kerecis.com/ifus/ifu-kerecis-surgiclose-compact7032878752info@kerecis.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2924891255655608K243843Tendon Protect (50242)OWY2025-06-04
2924891580721905K241080Kerecis Parvus (50207)KGN2024-08-21
2924891671447998K213231Kerecis SiliconeKGN2022-06-29
2924891424342713K202430Kerecis ReconstructOXH2021-05-02
2342691749320705K190528MariGen Wound ExtraKGN2019-07-10
2924891749320705K190528MariGen Wound ExtraKGN2019-07-10
2342691926044438K132343MARIGEN WOUND DRESSINGKGN2013-10-23
2924891926044438K132343MARIGEN WOUND DRESSINGKGN2013-10-23

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KGN62024-08-21
OWY12025-06-04
OXH12021-05-02

PMN#

GUDID#

80 records. Showing 1-40. Next