Irvine Biomedical Inc, a St. Jude Medical Co.

FDA Regulatory Profile

Irvine Biomedical Inc, a St. Jude Medical Co. appears in FDA public data with 2 recalls, 0 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-3011-2020, Class II) was initiated on August 24, 2020.

Summary

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

Known Names

irvine biomedical inc, a st. jude medical, irvine biomedical, inc., a st. jude medical

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