15 results
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49ms
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Sources: EU EUDAMED, US FDA
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