Medical device 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 HeraeusLabelled by claude-sonnet-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 14, 2026, FDA's public records list J.F. Jelenko & Co. with 56 510(k) clearances. The most recent is a 510(k) clearance dated Aug 22, 2001: JEL-20.
| Aug 22, 2001 | JEL-20K012303 · EJS | 510(k) clearances |
| Nov 16, 2000 | HERACERAMK002993 · EIH | 510(k) clearances |
| Oct 19, 2000 | JEL BIOS PUREK002645 · EJT | 510(k) clearances |
| Aug 31, 2000 | RD-2104K002222 · EJT | 510(k) clearances |
| Jun 20, 2000 | SIGNUMK001360 · EBF | 510(k) clearances |
| May 17, 2000 | ALLROUND 55 LFK001260 · EJT | 510(k) clearances |
| May 11, 2000 | JEL BIOS 90 (CODE NAME RD-2401)K001196 · EJT | 510(k) clearances |
| Apr 6, 2000 | JELDENT BASIC LINEK000213 · ELM | 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