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 3 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list ImaCor Inc. with 4 510(k) clearances and 2 device recalls. The most recent is a device recall dated Aug 29, 2025: ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE….
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 |
|---|---|---|
| Aug 29, 2025 | ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model Class II · Production assembly error resulting in the potential for reversed articulation, where moving the lever forward caused th | Device recalls |
| Sep 16, 2024 | ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Model/Catalog Number: Class II · Epoxy used to seal the edge of the transducer into its paddle exceeded specification. This variability could attenuate t | Device recalls |
| Apr 8, 2022 | ImaCor Zura Handheld ZHH-010K220490 · IYN | 510(k) clearances |
| Sep 29, 2014 | IMACOR ZURA EVO IMAGING SYSTEMK142054 · IYO | 510(k) clearances |
| Jun 25, 2010 | ZURA TEE SYSTEM WITH CLARITEE PROBEK100989 · IYN | 510(k) clearances |
| Jun 24, 2008 | ZURA TEE SYSTEMK080223 · IYO | 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
