Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in GermanyLabelled 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 15, 2026, FDA's public records list Heine Optotechnik and its 1 subsidiaries with 8 510(k) clearances. The most recent is a 510(k) clearance dated May 18, 2015: HEINE BETA 200, HEINE BETA 200 S, HEINE K 180.
| May 18, 2015 | HEINE BETA 200, HEINE BETA 200 S, HEINE K 180K142486 · HLJ | 510(k) clearances |
| Jan 29, 2015 | HEINE SIGMA 250 & HEINE SIGMA 250 M2K142837 · HLJ | 510(k) clearances |
| Mar 7, 2014 | HEINE MINI 3000(R) OPHTHALMOSCOPEK131959 · HLJ | 510(k) clearances |
| Dec 4, 2013 | HEINE BETA 200(R) OPHTHALMOSCOPEK131961 · HLJ | 510(k) clearances |
| Mar 22, 2013 | HEINE MINI 3000 LED OPHTHALMOSCOPEK123587 · HLJ | 510(k) clearances |
| Feb 26, 2013 | HEINE OMEGA 500K123316 · HLI | 510(k) clearances |
| Aug 27, 2010 | HEINE GAMMA G7; HEINE GAMMA G5, HEINE GAMMA GP, HEINE GAMMA GST, HEINE GAMMA XXL LF MODEL M-000.09.23X, M-000.09.24X, M-K101892 · DXQ | 510(k) clearances |
| Jan 12, 1995 | HEINE LAMBDA 100K944156 · HOX | 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
