Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER D, DM, AND OEM-D (SOFTWARE VERSION 5.1)

Dimension Vista® LOCI 4 CAL

FDA UDI

Siemens Healthcare Diagnostics Inc.·00842768033827·LOCI 4 Calibrator, 10 (2A x 2.0 mL; 2B x 2.0 mL...

Thermo Fisher

FDA UDI

SHANDON DIAGNOSTICS LIMITED·05051663001137·100-240V 50/60HZ WITHOUT STARTER KIT

Thermo Fisher

FDA UDI

SHANDON DIAGNOSTICS LIMITED·05051663001076·100-240V 50/60HZ WITH STARTER KIT

Thermo Fisher

FDA UDI

SHANDON DIAGNOSTICS LIMITED·05051663008754·100-240V 50/60HZ (CHINESE MAINSLEAD SET)

Thermo Fisher

FDA UDI

SHANDON DIAGNOSTICS LIMITED·05051663009225·110-240V 50/60HZ (US MAINSLEAD SET)

Thermo Fisher

FDA UDI

SHANDON DIAGNOSTICS LIMITED·05051663007856·100-240V 50/60HZ (SCHUKO MAINSLEAD SET)

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...

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

FDA UDI

ON-X LIFE TECHNOLOGIES, INC.·00851788001327·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.·00851788001488·The On-X® Prosthetic Heart Valve is a bileaflet...