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 LivaNovaLabelled by claude-sonnet-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 CarboMedics with 22 510(k) clearances. The most recent is a 510(k) clearance dated Jul 25, 1997: ANNULOFLO SYSTEM.
| Jul 25, 1997 | ANNULOFLO SYSTEMK970375 · KRH | 510(k) clearances |
| Feb 19, 1997 | VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION)K964665 · DSY | 510(k) clearances |
| Aug 27, 1996 | CARBOMEDICS HANDLEK962154 · DTJ | 510(k) clearances |
| Apr 29, 1996 | CARBOMEDICS MITRAL ROTATORK960923 · MOP | 510(k) clearances |
| Apr 25, 1996 | VASCUTEK VASCUSOFT PLUS VASCULAR GRAFTK960706 · DSY | 510(k) clearances |
| Apr 15, 1996 | CARBOMEDICS VALVE TESTERK960169 · DTJ | 510(k) clearances |
| Mar 7, 1996 | VASCUTEK GRAFT SIZER SETK955588 · DSY | 510(k) clearances |
| Nov 29, 1995 | CARBOMEDICS SUPRA-ANNULAR VALVE SIZERK952184 · DTI | 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
