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 Cardiomedics with 5 510(k) clearances. The most recent is a 510(k) clearance dated Mar 31, 2005: CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000.
| Mar 31, 2005 | CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000K050172 · DRN | 510(k) clearances |
| Jan 7, 2003 | CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000K023427 · DRN | 510(k) clearances |
| Aug 8, 2002 | CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000K022107 · DRN | 510(k) clearances |
| Feb 28, 2001 | CARDIOMEDICS ECP SYSTEMK010261 · DRN | 510(k) clearances |
| Sep 18, 1987 | CARDIOMEDICS EXTERNAL COUNTERPULSATION SYSTEMK872034 · DRN | 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
