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 Medical CV, Inc. with 6 510(k) clearances. The most recent is a 510(k) clearance dated Aug 8, 2008: ATRILAZE LASER ABLATION SYSTEM.
| Aug 8, 2008 | ATRILAZE LASER ABLATION SYSTEMK081457 · GEX | 510(k) clearances |
| Mar 16, 2007 | ATRILAZE MI SURGICAL ABLATION SYSTEMK061489 · GEX | 510(k) clearances |
| Apr 11, 2006 | ATRILAZE SURGICAL ABLATION SYSTEMK060680 · GEX | 510(k) clearances |
| Oct 11, 2005 | ATRILAZE MALLEABLE ABLATION PROBEK052495 · GEX | 510(k) clearances |
| Nov 30, 2004 | ATRILAZE SOFT TISSUE ABLATION SYSTEMK040744 · GEX | 510(k) clearances |
| Aug 3, 2004 | NORTHRUP UNIVERSAL ANNULOPLASTY SYSTEM, MODEL 1000K033685 · KRH | 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
