Medical device makerLabelled 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., part of Asahi KaseiLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Asahi Medical with 16 510(k) clearances. The most recent is a 510(k) clearance dated Jul 23, 2004: HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-….
| Jul 23, 2004 | HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EXK041726 · KDI | 510(k) clearances |
| Jul 9, 2002 | AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRYK013418 · KDI | 510(k) clearances |
| Aug 16, 2000 | APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS)K001250 · KDI | 510(k) clearances |
| Jul 29, 1999 | ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-XK991512 · FJI | 510(k) clearances |
| May 17, 1999 | ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS AM-BIO-50,AM-BIO-65, AM-BIO-75, AND AM-BIO-100, AM-BIO-K983720 · MSE | 510(k) clearances |
| Sep 30, 1997 | ASAHI AM-R SERIES DIALYZERSK970650 · MSE | 510(k) clearances |
| Mar 20, 1992 | MODIFIED ASAHI PAN-SERIES HEMOFILTERSK914020 · KDI | 510(k) clearances |
| Aug 8, 1990 | MODIFIED SEPACELL R-SERIES BLOOD FILTERSK901887 · CAK | 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
