FDA Device Entity Profile: LivaNova USA, Inc.

Known Identifiers & Locations

FEI Numbers 1000117004

Owner Operator Numbers 9002738

Locations Covered HOUSTON, TX, US

Registered Establishments (1)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
1644487	LivaNova USA, Inc.	HOUSTON, TX, US	Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device	View Details

510(k) Premarket Notifications (1)

Submission #	Device Name	Decision Date	Decision Description	Action
K233702	SMARxT Tubing and Connectors	2024-08-08	Substantially Equivalent	View Details

FDA Recall History (0)

No recall records found for this entity.

Profile Disclaimer

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