Company
Abbott Laboratories Inc. (St Jude Medical)
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 5, 2021 | Abbott Laboratories Inc. (St Jude Medical) WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012 Terminated |
DQK | K210392 |
| May 5, 2021 | Abbott Laboratories Inc. (St Jude Medical) v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System Display,
Model H700124, The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system d Terminated |
DQK | K210392 |
| May 5, 2021 | Abbott Laboratories Inc. (St Jude Medical) v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H700123. The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed fo Terminated |
DQK | K210392 |
| Apr 22, 2021 | Abbott Laboratories Inc. (St Jude Medical) NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000 Terminated |
GXD | K111576 |
| Apr 5, 2019 | Abbott Laboratories Inc. (St Jude Medical) TactiSys Quartz Equipment (with software version 1.7)
Model: PN-004 400
Part Numbers: 600043767 (China), 100154367 (Global), 100154368 (SWAP) Terminated |
OAE | None listed |