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 15, 2026, FDA's public records list Cardiac Recorders with 8 510(k) clearances. The most recent is a 510(k) clearance dated Mar 20, 1987: CARDIAN III CR6A.
| Mar 20, 1987 | CARDIAN III CR6AK864704 · DPS | 510(k) clearances |
| Sep 12, 1986 | CARDIAN II CR45AK861621 · DRT | 510(k) clearances |
| Dec 11, 1985 | CARDIORATER CR 51K853673 · DRT | 510(k) clearances |
| Nov 19, 1985 | CARDIORATER CR7K852910 · DRT | 510(k) clearances |
| Nov 14, 1985 | CR5 CARDIAC MONITORK852887 · DRT | 510(k) clearances |
| Nov 5, 1985 | CR 280/45, CR281/4 DEFIBRILLATORK852905 · LDD | 510(k) clearances |
| Sep 16, 1985 | CR26, CR26A, CR26B, CR26C(CARDIAC DC DEFIBRILLATO)K852808 · LDD | 510(k) clearances |
| Sep 16, 1985 | 2006, 2010, 2011, 2012(CARDIAC DC DEFIBRILLATOR)K852799 · LDD | 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
