Medical device makerLabelled by claude-haiku-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 13, 2026, FDA's public records list Ortho Instruments with 6 510(k) clearances. The most recent is a 510(k) clearance dated Dec 31, 1980: ORTHO HEMOTOLOGY CONTROL-NORMAL.
| Dec 31, 1980 | ORTHO HEMOTOLOGY CONTROL-NORMALK803083 · JPK | 510(k) clearances |
| Dec 31, 1980 | ORTHO HEMATOLOGY CONTROL ABNORMAL LOWK803084 · JPK | 510(k) clearances |
| Dec 31, 1980 | ORTHO HEMATOLOGY CONTROLK803073 · JPK | 510(k) clearances |
| Oct 10, 1980 | ORTHO SPECTRUMK802094 · GKL | 510(k) clearances |
| Sep 9, 1980 | ORTHO AUTOMATED CELL COUNTERK801545 · GKL | 510(k) clearances |
| Sep 14, 1978 | HEMAC LASER HEMATOLOGY SYSTEMK781146 · GKL | 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
