FDA-Device2025-09-17Class II
CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX only
CORNEAT VISION, LTD.
Hazard
Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would dehiscence.
Sold states
Worldwide - US Nationwide distribution in the states of AZ, CA, CO, DE, FL, GA, ID, IL, IN, KS, MA, MD, MI, MN, MO, MT, NC, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI, Puerto Rico and the countries of Argentina, Israel, Hong Kong.
Affected count
N/A
Manufactured in
4, Ha-Sheizaf, N/A, Ra'Anana, N/A, Israel
Products
CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX only
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2537-2025Don't want to check this manually?
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