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.. FDA files no records under this name; these are its 2 companies' records, each linked to the record.
As of Nov 14, 2026, FDA's public records list Gentherm and its 2 subsidiaries with 20 device recalls and 12 510(k) clearances. The most recent is a device recall dated Nov 27, 2017: Hemotherm¿ Dual Reservoir Cooler/Heater System Models 400CE and 400MR Product Usage: A….
Group recordsLabelled by a language model (which subsidiaries belong to the group) from the firm's FDA names. It is not an FDA field.: 32, 3 entities
Device recalls: 20
510(k) clearances: 12
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Gentherm and its 2 subsidiaries
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
12017Records1
220182018Records2vs 2017+1
72019Records7vs 2018+5
020202020Records0vs 2019−7
12021Records1vs 2020+1
120222022Records1vs 2021+0
02023Records0vs 2022−1
020242024Records0vs 2023+0
02025Records0vs 2024+0
320262026 to dateRecords3
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
