ESA 612

FDA UDI

FLUKE ELECTRONICS CORPORATION·00850540007058·Electrical Safety Analyzer

Model 7800

FDA UDI

IVY BIOMEDICAL SYSTEMS, INC.·00816396021341·Cardiac Gating Module

ECG

FDA UDI

Zoll Medical Corporation·00847946021566·CABLE, V LEAD ECG, IEC, PROPAQ MD

NA

FDA UDI

NIHON KOHDEN AMERICA, INC.·00841983102950·Transmitter, Multi Parameter, L-BAND 1.4 GHz

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Enticos 4 DR, Enticos 4

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Enticos 4 DR, Enticos 4

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·BELOS VR-T, BELOS DR-T, BELOS A +-T, LEXOS DR-T,LEXOS VR-T,XELOS DR-T, LUMOS DR-T,LUMOS VR-T

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·BELOS & LEXOS DR/DR-T/VR/VR-T/LUMOS DR-T/VR-T/XELOS DR-T

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PHILOS DR/DR-B/SR/SR-B/DR-T/PHILOS II DR/DR-T/SR/CYLOS DR/DR-T/VR/EVIA DR/DR-T/SR/SR-T/ENTOVIS DR/DR-T/SR/SR-T

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·BELOS & LEXOS DR/DR-T/VR/VR-T ICD'S, LUMOS DR-T/VR-T, XELOS DR-T ICD'S

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Acticor 7 DR-T DF4 ProMRI, Rivacor 3 DR-T DF4 ProMRI, Rivacor 5 DR-T DF4 ProMRI, Rivacor 7 DR-T DF4 ProMRI, Acticor 7 HF

The Circadia C200 System

FDA registration

Hi-P ELECTRONICS (MALAYSIA) SDN. BHD.·2 products·🇲🇾 Malaysia

Sleepiz

FDA registration

L-TEK D.O.O.·2 products·🇸🇮 Slovenia

eQuality

FDA registration

CRITICARE TECHNOLOGIES, INC.·2 products·🇺🇸 United States

Neteera 130H/131H Vital Sign Monitoring Sensor

FDA registration

NETEERA TECHNOLOGIES LTD·2 products·🇮🇱 Israel

Neteera 130H-Plus Vital Sign Monitoring Sensor

FDA registration

NETEERA TECHNOLOGIES LTD·2 products·🇮🇱 Israel

The Circadia C200 System

FDA registration

Circadia Health, Inc.·2 products·🇺🇸 United States

Sleepiz One+

FDA registration

Sleepiz AG·2 products·🇨🇭 Switzerland

SphygmoCor XCEL CP

FDA registration

ATCOR MEDICAL Pty Ltd·2 products·🇦🇺 Australia

BioButton MPU

FDA registration

BIOINTELLISENSE INC.·2 products·🇺🇸 United States