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 PhilipsLabelled 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 13, 2026, FDA's public records list Instromedix with 33 510(k) clearances. The most recent is a 510(k) clearance dated Jun 12, 2001: HEARTCARD, MODEL 5258.
| Date | Record | Source |
|---|---|---|
| Jun 12, 2001 | HEARTCARD, MODEL 5258K010945 · DXH | 510(k) clearances |
| Jul 23, 1997 | POSEIDON CARDIAC MONITORING SYSTEM (PCMS)K964408 · DPS | 510(k) clearances |
| Jul 18, 1997 | CARDIOMAGIC 2000 SOFTWAREK964036 · DXH | 510(k) clearances |
| Apr 8, 1996 | ACCELERATED TRANSMISSION PROTOCOLK955060 · DXH | 510(k) clearances |
| Jan 16, 1996 | LIFESIGNS RECEIVING CENER 2000 TRANSTELEPHONIC RECEIVERK951096 · DXH | 510(k) clearances |
| Nov 9, 1995 | HEARTHWATCH III(TM)K945476 · DXH | 510(k) clearances |
| Oct 31, 1995 | CARDIOMAGIC(R) SOFTWARE ENHANCEMENTSK950003 · DXH | 510(k) clearances |
| Sep 7, 1995 | HEARTCARD CARDIAC EVENT MONITORK944362 · DXH | 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
