Glycar SA Pty., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
2 (2 Class I)
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0532-2026Class ISJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INOctober 9, 2025
Z-0531-2026Class ISJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTOctober 9, 2025