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Wontech

Medical device maker in South Korea. FDA records under 2 spellings of its name, each linked to the record.

  • 510(k) clearances: 30

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 record
DateRecordSource
Dec 19, 2025SANDRO DualK252877 · GEX510(k) clearances
Jul 3, 2025PastelleK250165 · GEX510(k) clearances
May 14, 2025VeincareK251288 · GEX510(k) clearances
May 6, 2025Alma VeilK251094 · GEX510(k) clearances
Mar 12, 2025PICOALEXK243957 · GEX510(k) clearances
Feb 14, 2025WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)K241643 · GEX510(k) clearances
Feb 14, 2025Pastelle ProK241527 · GEX510(k) clearances
Jan 21, 2025Oligio XK243929 · GEI510(k) clearances

Canada and Imports

Matched by company name
Active Health Canada device licences
5, as of Nov 10, 2026

Names and Identifiers

Appears as
Wontech Co., Ltd.Wontech

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.