Graphic Controls Acquisition Corporation

FDA Regulatory Profile

Graphic Controls Acquisition Corporation appears in FDA public data with 6 recalls, 0 510(k) clearances, 8 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0937-2022, Class II) was initiated on March 15, 2022.

Summary

Total Recalls
6
510(k) Clearances
0
Inspections
8
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0937-2022Class IICLARAVUE Pre-wired Electrode - IP SET M5 RT ADULT-US Model: 32028778 50601-USMarch 15, 2022
Z-0936-2022Class IICLARAVUE Pre-wired Electrode - IP SET M3 RT ADULT-US Model: 32028777 50600 USMarch 15, 2022
Z-0939-2022Class IICLARAVUE Pre-wired Electrode - IP SET 6V RT ADULT-US Model: 32028780 50603-USMarch 15, 2022
Z-0940-2022Class IICLARAVUE Pre-wired Electrode - IP SET 5V RT ADULT Model: 32028781 50604-USMarch 15, 2022
Z-0938-2022Class IICLARAVUE Pre-wired Electrode - IP SET 12 RT ADULT-US Model: 32028779 50602-USMarch 15, 2022
Z-0935-2022Class IICLARAVUE Pre-wired Electrode IP-SET N3 - PEDIATRIC-US Model: 32028776 50401-USMarch 15, 2022