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Medical device makerAI in United StatesAI. FDA records under 5 spellings of its name, each linked to the record.

• Records across the group: 924, 32 entitiesAI
• 510(k) clearances: 825
• Device recalls: 74
• Drug applications: 20
• Complete response letters: 2

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