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 ChinaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Contec Medical Systems Co., Ltd. with 24 510(k) clearances, 1 device recall and 1 warning letter. The most recent is a warning letter dated Oct 2, 2025: Warning letter: CAPA, Complaint handling, Design controls.
510(k) clearances: 24
Device recalls: 1
Warning letters: 1
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
22017Records2
120182018Records1vs 2017−1
12019Records1vs 2018+0
120202020Records1vs 2019+0
12021Records1vs 2020+0
120222022Records1vs 2021+0
02023Records0vs 2022−1
320242024Records3vs 2023+3
22025Records2vs 2024−1
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
