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 GermanyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 5 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Biotronik and its 1 subsidiaries with 145 510(k) clearances and 26 device recalls. The most recent is a 510(k) clearance dated May 1, 2026: BIOMONITOR IV (471155).
Group recordsLabelled by a language model (which subsidiaries belong to the group) from the firm's FDA names. It is not an FDA field.: 171, 2 entities
510(k) clearances: 145
Device recalls: 26
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Biotronik and its 1 subsidiaries
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
32017Records3
120182018Records1vs 2017−2
32019Records3vs 2018+2
320202020Records3vs 2019+0
262021Records26vs 2020+23
320222022Records3vs 2021−23
22023Records2vs 2022−1
320242024Records3vs 2023+1
12025Records1vs 2024−2
120262026 to dateRecords1
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
