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

FDA Pre-Market Approval

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

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Valitude and Visionist Non-MRI CRT-Ps and Valitude X4 and Visionist X4 MRI CRT-Ps

AutoScan-DS-EX Pro(H),A-IS Pro3,OS GOLDY,Capella M5,OS-300

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Shining 3D Tech Co., Ltd.·4 devices

Skin Electrical Conductance Meters

Basic UDI-DI

EU MDD · Eu Md Class 2a ·Qinhuangdao Huisianpu Medical Systems Inc·1 device

SureStep Hinged AFO

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Surestep, LLC·1 device

Finapres NOVA NanoCore

FDA registration

FINAPRES MEDICAL SYSTEMS B.V.·4 products·🇳🇱 Netherlands

Vios Monitoring System™ Model 2050

FDA registration

Murata Vios, Private Limited·4 products·🇮🇳 India

Vios Monitoring System™ Model 2050

FDA registration

Murata Vios, Inc.·4 products·🇺🇸 United States

Finapres NOVA NanoCore

FDA registration

DEMCON PRODUCTION B.V.·4 products·🇳🇱 Netherlands

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PUNCTUA CRT-DS,COGNIS CRT-DS,ENERGEN CRT-DS,INCEPTA CRT-DS,ORIGEN CRT-DS,INOGEN CRT-DS,DYNAGEN CRT-DS

Leadless Cardiac Resynchronization Therapy (Crt)

FDA Pre-Market Approval

FDA Class 3 ·WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System

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

FDA Pre-Market Approval

FDA Class 3 ·Advanced Valve Metal (AVM) capacitor

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC SECURA DR D204DRM, MAXIMO II D264DRM, IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

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

FDA Pre-Market Approval

FDA Class 3 ·Cobalt XT HF Quad CRT-D MRI SureScan (DTPA2QQ, DTPA2Q1); Cobalt XT HF CRT-D MRI SureScan (DTPA2D4 and DTPA2Dl); Cobalt H

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Cobalt XT DR MRI SureScan (DDPA2D4 and DDPA2Dl); Cobalt DR MRI SureScan (DDPB3D4 and DDPB3Dl); Crome DR MRI SureScan (DD

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval

FDA Class 3 ·CARELINK HOME MONITOR MODEL 2490C, CARDIOSIGHT READER MODEL 2020A, CAELINK NETWORK DEVICE

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

FDA Pre-Market Approval

FDA Class 3 ·Resonate family of CRT-D's

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Advanced Valve Metal (AVM) capacitor

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Resonate family of CRT-D's

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·VALITUDE™, VALITUDE X4, VISIONIST™, VISIONIST X4