Irvine Biomedical Inc, a St. Jude Medical Co.

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
Z-3011-2020Class IIInquiry Steerable Diagnostic Catheter, REF: IBI-81104 - Product Usage: INDICATIONS FOR USE The InquiAugust 24, 2020
Z-3012-2020Class IIInquiry Steerable Diagnostic Catheter, REF: IBI-87002 - Product Usage: INDICATIONS FOR USE The InquiAugust 24, 2020