Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·QUICKSEAL SURESHOT ARTERIAL CLOSURE SYSTEM

BE Micro Headbox

FDA UDI

EB NEURO SPA·08056446900055·Patient-interface for EEG ambulatory recorder

BluPRO®

FDA UDI

NIHON KOHDEN AMERICA, INC.·10841983102728·SpO2 probe Child (from 10 to 50 kg) Finger or t...

BluPRO®

FDA UDI

NIHON KOHDEN AMERICA, INC.·10841983102711·SpO2 probe Adults (30 kg or more) Finger or toe...

NA

FDA UDI

NIHON KOHDEN AMERICA, INC.·00841983101182·Camera Capture Unit

Micromed

FDA UDI

MICROMED SPA·08033928120958·software for acquisition, review, storage , pro...

BE Micro Recorder

FDA UDI

EB NEURO SPA·08056446900017·EEG Long Term-Abulatory Recorder

BluPRO®

FDA UDI

NIHON KOHDEN CORPORATION·14931921878597·SpO2 probe Child / Infant (from 3 to 20 kg) Fin...

Live View Panel Version 1.4

FDA UDI

Neurotronics, LLC·00817111020816·Live View Panel Version 1.4

micromed

FDA UDI

MICROMED SPA·08033928120880·software for acquisition, review, storage , pro...

Live View Panel Version 1.3

FDA UDI

Neurotronics, LLC·00817111020786·Live View Panel Version 1.3

BluPRO®

FDA UDI

NIHON KOHDEN CORPORATION·04931921005828·SpO2 probe Adults (30 kg or more) Finger or toe...

BE Micro USB BRIDGE

FDA UDI

EB NEURO SPA·08056446900024·USB interface for EEG ambulatory recorder

JB CERVELLO 64

FDA UDI

BLACKROCK NEUROMED, LLC·00850154007055·JackBox with 64 Common Reference Inputs, with 6...

MORPHEUS

FDA UDI

BLACKROCK NEUROMED, LLC·00850154007079·Micromed MORPHEUS Amplifer for HOME LTM.

CERVELLO SOFTWARE

FDA UDI

BLACKROCK NEUROMED, LLC·00850154007086·Cervello Software for use with Blackrock Neurom...

BE Micro PLUG-IN HEADBOX 19 CH MONO+2CH BIPOL

FDA UDI

EB NEURO SPA·08056446900956·Patient-interface for EEG ambulatory recorder

CERVELLO 32

FDA UDI

BLACKROCK NEUROMED, LLC·00850154007000·Cervello 32 LTM / Ambulatory Headbox, needs Jac...

BluPRO®

FDA UDI

NIHON KOHDEN CORPORATION·14931921878535·SpO2 probe Adults (30 kg or more) Finger or toe...

CERVELLO 32 W

FDA UDI

BLACKROCK NEUROMED, LLC·00850154007024·Cervello 32 LTM / Ambulatory Headbox, needs Jac...