RESOLVE-CSF

FDA 510(k)

FDA Class 1 ·Immunology

FIAX IGG TEST

FDA 510(k)

FDA Class 1 ·Immunology

Roadrunner

FDA UDI

COOK INCORPORATED·00827002187931·Roadrunner, PC Double Flexible Wire Guide With ...

Roadrunner

FDA UDI

COOK INCORPORATED·00827002187917·Roadrunner, PC Double Flexible Tip Wire Guide W...

Roadrunner

FDA UDI

COOK INCORPORATED·00827002187924·Roadrunner, PC Double Flexible Tip Wire Guide W...

Roadrunner

FDA UDI

COOK INCORPORATED·00827002187948·Roadrunner, PC Double Flexible Tip Wire Guide W...

Roadrunner

FDA UDI

COOK INCORPORATED·00827002465503·Roadrunner PC Double Flexible Tip Wire Guide W...

Roadrunner

FDA UDI

COOK INCORPORATED·00827002465510·Roadrunner PC Double Flexible Tip Wire Guide W...

Roadrunner

FDA UDI

COOK INCORPORATED·00827002569911·Roadrunner, PC Double Flexible Tip Wire Guide W...

Roadrunner

FDA UDI

COOK INCORPORATED·00827002569904·Roadrunner, PC Double Flexible Tip Wire Guide W...

CYBOW R-60S

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·DFI Co.,Ltd.·3 devices

CYBOW R-50S

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·DFI Co.,Ltd.·6 devices

CYBOW R-600S

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·DFI Co.,Ltd.·4 devices

CYBOW Reader 300

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·DFI Co.,Ltd.·5 devices

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera/MRI/DF, ICD, S DR, XT DR, S VR, XT VR, Maximo II ICD, Secura DR ICD/ DR, Visia AF MRI DFI ICD/VR ICD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF ICD /MRI ICD / S DR / S VR / XT DR /XT VR ICD's; Visia AF MRI DFI ICD / AF MRI VR ICD / AF VR ICD.

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF-I ICD,EVERA MRI ICD, Evera S DR/S VR/XT DR/ XT VR ICD, Intrinsic 30 ICD, Marquis VR ICD, Maxmo II ICD,

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF-I ICD/Evera MRI ICD/ Evera S DR ICD/Evera S VR ICD/ Evera XT DR ICD/ Evera XT VR ICD/ Visia AF MRI DF1 ICD/

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF-I ICD / Evera MRI ICD/ S DR ICD / S VR ICD / XT DR ICD /XT VR ICD ; Mirro MRI DR ICD / MRI VR ICD; Primo MR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF ICD, MRI ICD, S DR ICD, S VR ICD, XT DR ICD, XT VR ICD - Visia AF MRI DFI ICD, AF MRI VR ICD, AF VR ICD