Kardium

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
2
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0054-2013Class IITORQ Sternal Closure Device. The common name is TWISTER, WIRE. The model number is TQ01A. TheAugust 28, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K250747Globe® Pulsed Field SystemJune 25, 2025
K250529Globe Introducer (601-01001)June 3, 2025