FirmLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in JapanLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Kaneka Corporation and its 4 subsidiaries with 18 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Jan 5, 2026: SurfRider 13 Microcatheter.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Kaneka Corporation and its 4 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Jan 5, 2026 | SurfRider 13 MicrocatheterK251668 · QJP | 510(k) clearances |
| Feb 17, 2022 | LIPOSORBER System, Model: LA-15, consisting of: Apheresis machine, product# 101445 model: MA-03, and disposables (product#, model) Class II · Labeling change to due to the risk of severe anaphylactoid reactions including shock in patients treated with the Liposo | Device recalls |
| Oct 26, 2021 | Thrombuster II Aspiration CatheterK213166 · QEZ | 510(k) clearances |
| Mar 26, 2021 | i-ED COIL SystemK210638 · HCG | 510(k) clearances |
| Apr 25, 2020 | i-ED COILK192068 · HCG | 510(k) clearances |
| Mar 19, 2018 | OTW Takeru PTCA Balloon Dilatation CatheterK172264 · LOX | 510(k) clearances |
| Jul 7, 2017 | RX NC Takeru PTCA Balloon Dilatation CatheterK170941 · LOX | 510(k) clearances |
| Apr 18, 2017 | Lacriflow CLK170247 · OKS | 510(k) clearances |
| Apr 7, 2017 | RX Takeru Balloon Dilatation CatheterK163372 · LOX | 510(k) clearances |
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
