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Jolife AB

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
5
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2161-2026Class IILUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UDI-DI code: 008838739April 13, 2026
Z-1998-2025Class IILUCAS 2, 3 and 3.1 LUCAS chest compression System is to be used for performing external cardiac cMay 21, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K173553LUCAS 3 Chest Compression SystemFebruary 8, 2018
K161768LUCAS 3 Chest Compression SystemNovember 9, 2016
K090422LUCAS 2June 17, 2009
K062401MODIFICATION TO LUCASSeptember 28, 2006
K053403LUCASFebruary 1, 2006