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., part of BiotronikLabelled 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 Biotronik Sales with 41 510(k) clearances. The most recent is a 510(k) clearance dated Feb 18, 1988: NP BIPOLAR ENDOCARDIAL LEAD W/VS-1 CONNECTOR.
| Feb 18, 1988 | NP BIPOLAR ENDOCARDIAL LEAD W/VS-1 CONNECTORK875199 · DTB | 510(k) clearances |
| Mar 11, 1987 | ERA-20K853194 · DTE | 510(k) clearances |
| Jan 12, 1987 | EDP-20 PACEMAKERK860036 · DXY | 510(k) clearances |
| Dec 10, 1986 | NEOS-M VS-1 PULSE GENERATORK863879 · DXY | 510(k) clearances |
| Dec 10, 1986 | TRIOS-M VS-1 PULSE GENERATORK863878 · DXY | 510(k) clearances |
| Sep 23, 1986 | BIOTRONIK PERMANENT PACEMAKER ELECTRODEK863480 · DTB | 510(k) clearances |
| Aug 8, 1986 | NEOS VS-1, PULSE GENERATORK860921 · DXY | 510(k) clearances |
| Aug 4, 1986 | MIKROS, MIKROS VS-1, PULSE GENERATORK860922 · DXY | 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
