Company ยท US
Abbott (St. Jude Medical)
FDA 510(k) clearances and medical device recalls filed under this name, 2019 to 2021. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 13, 2021 | K212206 | Jot Dx Insertable Cardiac Monitor Abbott (St. Jude Medical) | MXC |
| Dec 1, 2020 | K202876 | Confirm Rx Insertable Cardiac Monitor Abbott (St. Jude Medical) | MXC |
| Nov 23, 2020 | K202888 | Confirm Rx Insertable Cardiac Monitor Abbott (St. Jude Medical) | MXC |
| Jun 3, 2020 | K200721 | Agilis HisPro Steerable Catheter With Electrodes Abbott (St. Jude Medical) | DQY |
| Mar 17, 2020 | K193310 | myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) Abbott (St. Jude Medical) | MXC |
| Apr 10, 2019 | K190295 | Confirm Rx Insertable Cardiac Monitor Abbott (St. Jude Medical) | MXC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||