15 results · 49ms · Sources: EU EUDAMED, US FDA

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UNETIXS VASCULAR, INC.

FDA registration
UNETIXS VASCULAR, INC.·1 product·🇺🇸 United States

Unetixs Vascular

FDA UDI
UNETIXS VASCULAR, INC.·B4371199606·The MultiLab Series 2 2CP is intended for use a...

Unetixs Vascular

FDA UDI
UNETIXS VASCULAR, INC.·B437129500·The Revo is intended for use as a non-invasive ...

Unetixs Vascular

FDA UDI
UNETIXS VASCULAR, INC.·B4371198605·The MultiLab is intended for use as a non-invas...

Unetixs Vascular

FDA UDI
UNETIXS VASCULAR, INC.·B4371194904·The MultiLab Series 2 LHS is intended for use a...

UNETIXS VASCULAR

FDA Adverse Event
Death ·UNETIXS VASCULAR INC·Product code JAF·January 4, 2023

MULTILAB SERIES II ERGO-IDC

FDA Adverse Event
Death ·UNETIXS VASCULAR, INC·Product code JAF·December 19, 2022

MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000-01

FDA Recall
Open, Classified ·Unetixs Vascular, Inc.·Product code JAF·February 10, 2023

MultiLab Series II LHS TI & ERGO non-invasive vascular diagnostic device, Model Number 11949-0000-01

FDA Recall
Open, Classified ·Unetixs Vascular, Inc.·Product code JAF·February 10, 2023

MultiLab Series II REVO non-invasive vascular diagnostic device, Model Number 12950-0000-01

FDA Recall
Open, Classified ·Unetixs Vascular, Inc.·Product code JAF·February 10, 2023

MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device, Model Number 11996-0000-01

FDA Recall
Open, Classified ·Unetixs Vascular, Inc.·Product code JAF·February 10, 2023

MultiLab Series II REVO non-invasive vascular diagnostic device, Model Number 12950-0000-01

FDA Enforcement
Class II ·Ongoing·Unetixs Vascular, Inc.·March 8, 2023

MultiLab Series II LHS TI & ERGO non-invasive vascular diagnostic device, Model Number 11949-0000-01

FDA Enforcement
Class II ·Ongoing·Unetixs Vascular, Inc.·March 8, 2023

MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device, Model Number 11996-0000-01

FDA Enforcement
Class II ·Ongoing·Unetixs Vascular, Inc.·March 8, 2023

MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000-01

FDA Enforcement
Class II ·Ongoing·Unetixs Vascular, Inc.·March 8, 2023