CORNEAT VISION, LTD.

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
1
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0039-2026Class IICorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100August 18, 2025
Z-0040-2026Class IIEverPatch+, REF: 1044002, Permanent Scleral Reinforcement Matrix 1x5.0mm x 8.5 mm Shield/1 x 5.0mm xAugust 18, 2025
Z-2537-2025Class IICorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100October 16, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K223074CorNeat EverPatchJune 2, 2023