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 Medicore with 6 510(k) clearances. The most recent is a 510(k) clearance dated Sep 13, 2021: IRIS-XP.
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.
| Sep 13, 2021 | IRIS-XPK212412 · LHQ | 510(k) clearances |
| Jun 13, 2011 | MAX PULSE SYSTEMK110374 · JOM | 510(k) clearances |
| Nov 29, 2007 | SA-3000PK073323 · JOM | 510(k) clearances |
| Feb 9, 1999 | LITE-TOUCH SYRINGEK983430 · FMF | 510(k) clearances |
| Mar 21, 1988 | MEDI-LETK880869 · FMK | 510(k) clearances |
| Mar 26, 1981 | MEDI-LANCEK810681 · FMK | 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
