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.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Artivion and its 2 subsidiaries with 5 device recalls and 4 510(k) clearances. The most recent is a device recall dated Feb 1, 2026: On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Artivion and its 2 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Feb 1, 2026 | On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33Class II · Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they | Device recalls |
| Oct 2, 2025 | CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00)K252059 · OHA | 510(k) clearances |
| Dec 13, 2016 | Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement prostheses to repair the mitral valve anClass II · Four issues were uncovered by the recalling firm's CAPA: 1) Burrs were found to be present on Left Housing, Right Housin | Device recalls |
| Jun 6, 2014 | CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENTK141060 · PAW | 510(k) clearances |
| Mar 7, 2013 | HERO GRAFTK124039 · DSY | 510(k) clearances |
| Aug 16, 2012 | CHORD-X EPTFE SUTUREK121173 · PAW | 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
