Abbott (St. Jude Medical)

FDA Regulatory Profile

Abbott (St. Jude Medical) appears in FDA public data with 0 recalls, 6 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on August 13, 2021.

Summary

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

Recent 510(k) Clearances

K-NumberDeviceDate
K212206Jot Dx Insertable Cardiac MonitorAugust 13, 2021
K202876Confirm Rx Insertable Cardiac MonitorDecember 1, 2020
K202888Confirm Rx Insertable Cardiac MonitorNovember 23, 2020
K200721Agilis HisPro Steerable Catheter With ElectrodesJune 3, 2020
K193310myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)March 17, 2020
K190295Confirm Rx Insertable Cardiac MonitorApril 10, 2019