140 results · 30ms · Sources: EU EUDAMED, US FDA

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·IBI THERAPY DUAL 8 ABLATION CATHETERS

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·CLARION CII BIONIC EAR SYSTEM (ADULT)

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·CLARION CII BIONIC EAR SYSTEM (PEDIATRIC)

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·CALRION CII BIONIC EAR SYSTEM (ADULT)

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·IBI THERAPY DUAL 8 ABLATION CATHETERS

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·HIRESOLUTION & CLARION CII BIONIC EAR SYSTEMS

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·CLARION CII BIONIC EAR SYSTEM HIFOCUS ELECTRODE

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·CareLink SmartSync™ Micra VR App, CareLink SmartSync™ Micra AV App

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·LATITUDE NXT PATIENT MANAGEMENT SYSTEM

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·PSW 2202.U and NEO 2202.U

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·LATITUDE CONSULT SYSTEM

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

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·Renamic Neo Programmer

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC CARELINK MONITOR, MYCARELINK PATIENT MONITOR

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·REVEAL DX, REVEAL XT

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC MODELS 2490C CARELINK REMOTE HOME MONITORS

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·MYCARELINK SMART MONITOR AND THE MYCARELINK HEART APPLICATION

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·LATITUDE PATIENT MANAGEMENT SYSTEM, WAVE COMMUNICATOR MODEL 6290; NXT SYSTEM SEVER SOFTWARE MODEL 6460

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·PSW 2201.U/1 and NEO 2201.U/1

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·LATITUDE CONSULT SYSTEM