Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in South KoreaLabelled 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 13, 2026, FDA's public records list Infinitt with 13 510(k) clearances. The most recent is a 510(k) clearance dated Mar 24, 2017: INFINITT ULite.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Mar 24, 2017 | INFINITT ULiteK163290 · LLZ | 510(k) clearances |
| Sep 13, 2011 | XELIS CARDIACK111660 · LLZ | 510(k) clearances |
| Sep 8, 2011 | XELIS FUSIONK111613 · LLZ | 510(k) clearances |
| Jul 28, 2011 | XELIS 3DK103130 · LLZ | 510(k) clearances |
| Oct 1, 2010 | XELIS DENTALK102684 · LLZ | 510(k) clearances |
| Nov 20, 2008 | INFINITT XELISK082990 · LLZ | 510(k) clearances |
| Nov 6, 2008 | INFINITT CARDIOLOGY PACSK082706 · LLZ | 510(k) clearances |
| Nov 8, 2005 | INFINITT G3 PACSK052545 · LLZ | 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
