Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 6 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Intuitive Surgical and its 3 subsidiaries with 257 device recalls, 228 510(k) clearances and 2 AI-enabled devices. The most recent is a 510(k) clearance dated Oct 30, 2026: da Vinci Xi Surgical System (IS4000);da Vinci X Surgical System (IS4200).
Group recordsLabelled by a language model (which subsidiaries belong to the group) from the firm's FDA names. It is not an FDA field.: 487, 4 entities
Device recalls: 257
510(k) clearances: 228
AI-enabled devices: 2
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Intuitive Surgical and its 3 subsidiaries
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
342017Records34
2120182018Records21vs 2017−13
122019Records12vs 2018−9
2920202020Records29vs 2019+17
112021Records11vs 2020−18
1720222022Records17vs 2021+6
112023Records11vs 2022−6
1820242024Records18vs 2023+7
622025Records62vs 2024+44
2720262026 to dateRecords27
Latest Records
Newest first across sources; each opens the record
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
