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., part of StrykerLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
510(k) clearances: 8
Device recalls: 8
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
02017Records0
720182018Records7vs 2017+7
02019Records0vs 2018−7
320202020Records3vs 2019+3
02021Records0vs 2020−3
020222022Records0vs 2021+0
02023Records0vs 2022+0
020242024Records0vs 2023+0
02025Records0vs 2024+0
020262026 to dateRecords0
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
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.
