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Medical device makerAI in South KoreaAI. FDA records under 2 spellings of its name, each linked to the record.
- 510(k) clearances: 2
- AI-enabled devices: 2
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
Latest Records
Newest first across sources; each opens the recordNames and Identifiers
- Appears as
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