Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Sakura Finetek 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 15, 2026, FDA's public records list Sakura Finetek USA with 4 510(k) clearances and 1 device recall. The most recent is a device recall dated Apr 16, 2014: Tissue-Tek PARAFORM PROC/EMB/MEDIUM, FORMULA 3 - 8x1Kg. for diagnostic chemistry use. ….
| Apr 16, 2014 | Tissue-Tek PARAFORM PROC/EMB/MEDIUM, FORMULA 3 - 8x1Kg. for diagnostic chemistry use. Sakura Finetek USA, Inc.Class II · This Lot has variations in melting temperature. | Device recalls |
| Sep 7, 1989 | SAKURA PREP AI AUTOMATIC LIQUID HANDLING SYSTEMK893811 · JQW | 510(k) clearances |
| Jul 28, 1988 | SAKURA-MEDSCAND SCA-1800 AUTOMATIC COVERSLIPPERK882881 · KES | 510(k) clearances |
| Jul 1, 1988 | SAKURA HEM-480 ELECTRON MICROSCOPY PROCESSORK881165 · IEO | 510(k) clearances |
| Jan 5, 1988 | SAKURA DRS-60 AUTOMATIC SLIDE STAINERK874897 · KPA | 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
