Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·On-X Aortic Prosthetic Heart Valve Low Dose Warfarin Post Approval Clinical Registry Study

Silex

FDA UDI

SILEX MEDICAL, LLC·B331ONX1056L45·Locking Long Single-Action Retraction Grasping ...

Silex

FDA UDI

SILEX MEDICAL, LLC·B331ONX1024L45·Locking Long Fenestrated Grasping Forceps

Nanox.ARC

FDA UDI

NANO-X IMAGING LTD·07290018465004·

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·On-X Prosthetic Heart Valve

SprintRay OnX Tough - Bleach

FDA UDI

Sprintray, Inc.·00850039704536·The material is an alternative to traditional d...

SprintRay OnX Tough - A1

FDA UDI

Sprintray, Inc.·00850039704512·The material is an alternative to traditional d...

OnX Tough - Hollywood Bleach

FDA UDI

Sprintray, Inc.·00850039704178·The material is an alternative to traditional d...

SprintRay OnX Tough - B1

FDA UDI

Sprintray, Inc.·00850039704529·The material is an alternative to traditional d...

On-X Aortic Heart Valve with Conform-X Sewing Ring

FDA UDI

ON-X LIFE TECHNOLOGIES, INC.·00851788001365·The On-X® Prosthetic Heart Valve is a bileaflet...

On-X Heart Valve Instruments

FDA UDI

ON-X LIFE TECHNOLOGIES, INC.·00851788001020·Rotator for heart valve size 19. The valve rota...

On-X Aortic Heart Valve with Standard Sewing Ring

FDA UDI

ON-X LIFE TECHNOLOGIES, INC.·00851788001211·The On-X® Prosthetic Heart Valve is a bileaflet...

On-X Aortic Heart Valve with Standard Sewing Ring

FDA UDI

ON-X LIFE TECHNOLOGIES, INC.·00851788001235·The On-X® Prosthetic Heart Valve is a bileaflet...

On-X Aortic Heart Valve with Anatomic Sewing Ring and Extended Holder

FDA UDI

ON-X LIFE TECHNOLOGIES, INC.·00851788001662·The On-X® Prosthetic Heart Valve is a bileaflet...

On-X Aortic Heart Valve with Conform-X Sewing Ring

FDA UDI

ON-X LIFE TECHNOLOGIES, INC.·00851788001341·The On-X® Prosthetic Heart Valve is a bileaflet...

On-X Aortic Heart Valve with Conform-X Sewing Ring and Extended Holder

FDA UDI

ON-X LIFE TECHNOLOGIES, INC.·00851788001464·The On-X® Prosthetic Heart Valve is a bileaflet...

On-X Aortic Heart Valve with Standard Sewing Ring

FDA UDI

ON-X LIFE TECHNOLOGIES, INC.·00851788001242·The On-X® Prosthetic Heart Valve is a bileaflet...

On-X Aortic Heart Valve with Conform-X Sewing Ring and Extended Holder

FDA UDI

ON-X LIFE TECHNOLOGIES, INC.·00851788001471·The On-X® Prosthetic Heart Valve is a bileaflet...

On-X Aortic Heart Valve with Conform-X Sewing Ring

FDA UDI

ON-X LIFE TECHNOLOGIES, INC.·00851788001358·The On-X® Prosthetic Heart Valve is a bileaflet...

On-X Aortic Heart Valve with Anatomic Sewing Ring

FDA UDI

ON-X LIFE TECHNOLOGIES, INC.·00851788001624·The On-X® Prosthetic Heart Valve is a bileaflet...