FDA Device Entity Profile: ImaCor Inc

Known Identifiers & Locations

FEI Numbers 3006382185

Owner Operator Numbers 10023490

Locations Covered Jericho, NY, US

Registered Establishments (1)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
3006382185	IMACOR, Inc	Jericho, NY, US	Manufacture Medical Device	View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (1)

Recall #	Product Description	Initiation Date	Status	Action
Z-0038-2026	ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH. Reason: Production assembly error resulting in the potential for reversed articulation, where moving the lever forward caused the probe tip to anteflex rather than retroflex, and vice versa.	2025-08-29	Open, Classified	View Details

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