Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, and PERCIVA (ICD Dev

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

FDA Pre-Market Approval

FDA Class 3 ·INVIVE, INTUA, VISIONIST and VALITUDE (CRT-P Resynchronization Devices)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI and ACCOLADE MRI (Pacemaker Devices)

Impla-NX (Model: ISE-270M)

FDA 510(k)

FDA Class 1 ·Dental

Dental Handpiece, Model CA160, CA160L, and CA500L

FDA 510(k)

FDA Class 1 ·Dental

NX STAGE WATER PURIFICATION SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MEG-TORQ

FDA 510(k)

FDA Class 1 ·Dental

Dental Handpiece, Wireless Endodontic Handpiece, endoit

FDA 510(k)

FDA Class 1 ·Dental

ELEC-LED

FDA 510(k)

FDA Class 1 ·Dental

Dental Handpiece

FDA 510(k)

FDA Class 1 ·Dental

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LATITUDE NXT 2.0 PATIENT MANAGEMENT SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LATITUDE NXT Release Patient Management System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Subcutaneous ICD Devices EMBLEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ADVANTIO, INGENIO, VITALO, FORMIO, ESSENTO, ACCOLADE, PROPONENT Families of Pacemaker Devices

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

FDA Pre-Market Approval

FDA Class 3 ·CRT-D Resynchronization Devices COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM,

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

FDA Pre-Market Approval

FDA Class 3 ·CRT-P Resynchronization Devices INVIVE, INTUA, VISIONIST, VALITUDE

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, PERCIVA, RESONATE, MOMENTUM, VIGILANT

ComboLab AltiX AI.i

FDA registration

GE Medical Systems Information Technologies, Inc.·3 products·🇺🇸 United States

IntelliVue GuardianSoftware

FDA registration

Philips Medizin Systeme Boeblingen GmbH·3 products·🇩🇪 Germany

Vityl Sync Informatics Manager & Virtual Patient Monitoring Platform

FDA registration

Covidien·3 products·🇺🇸 United States