Abbott
Medical device makerAI in United StatesAI. FDA records under 10 spellings of its name, each linked to the record.
- Records across the group: 1,061, 37 entitiesAI
- 510(k) clearances: 740
- Device recalls: 203
- Drug applications: 113
- AI-enabled devices: 4
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Abbott and its 36 subsidiaries
Latest Records
Newest first across sources; each opens the recordSubsidiaries and Divisions
36 firms in the Abbott group, most records first- St. Jude Medical205 records
- Telectronics107 records
- Abbott Medical106 records
- Unipath73 records
- Biosite45 records
- Thoratec Corporation35 records
- Axis-Shield Diagnostics32 records
- Advanced Neuromodulation Systems32 records
- Luminex Molecular Diagnostics28 records
- i-STAT Corporation21 records
- Medamicus, Inc.20 records
- EP MedSystems15 records
- MediSense, Inc.15 records
- Selfcare, Inc.15 records
- Devices for Vascular Intervention, Inc.14 records
- Irvine Biomedical, Inc.14 records
- IDEV Technologies12 records
- Oximetrix12 records
- Wampole Laboratories12 records
- Lightlab Imaging10 records
- Jomed9 records
- Endocardial Solutions8 records
- Vysis8 records
- Panbio Limited7 records
- Axis-Shield POC4 records
- CardioMEMS4 records
- Evalve4 records
- Pan Bio Pty. Ltd.4 records
- Axis-Shield3 records
- MediGuide, Ltd.3 records
- AGA Medical Products, Inc.2 records
- St. Jude Medical, CRMD1 records
- St. Jude Medical Cardiovascular Group1 records
- St. Jude Medical Atrial Fibrillation Division1 records
- St. Jude Medical Endocardial Solutions1 records
- St. Jude Medical Mediguide Navigation Systems1 records
Canada and Imports
Across the Abbott group, matched by company nameNames and Identifiers
- Appears as
- FEI numbers in warning letters
- Website
- abbott.com
- Wikidata
- Q306764
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built