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 Universal Medical with 8 510(k) clearances. The most recent is a 510(k) clearance dated Dec 15, 2008: HEARTRAK SMART ECAT.
| Dec 15, 2008 | HEARTRAK SMART ECATK083535 · DXH | 510(k) clearances |
| May 14, 2008 | HEARTRAK AFK071130 · DXH | 510(k) clearances |
| Feb 5, 2004 | HEARTRAK SMART AT/HEARTRAK SMART2K033451 · DXH | 510(k) clearances |
| May 11, 1998 | CARDIOSTATIONK980624 · DXH | 510(k) clearances |
| Aug 6, 1996 | HEARTRAK XLK960499 · DXH | 510(k) clearances |
| Apr 22, 1996 | PACETRAK PLUSK954495 · DXH | 510(k) clearances |
| May 3, 1995 | PACETRAKK943123 · DXH | 510(k) clearances |
| May 3, 1995 | HEARTRAKK943124 · 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
