66 results · 17ms · Sources: EU EUDAMED, US FDA

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

FDA Pre-Market Approval
FDA Class 3 ·CONTAK RENEWAL TR CRT-P SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·VENTAK PRX AICD SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·VENTAK AV ACID SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·CONTAK CD/EASYTRACK CRT-D SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·VIGOR DR/SR PACEMAKER SYSTEM

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·VENTAK PRX AND VENTAK MINI SYSTEMS

Ophthalmic Sealant

FDA Pre-Market Approval
FDA Class 3 ·RESURE SEALANT

Sensor, Glucose, Invasive, Non-Adjunctive

FDA Pre-Market Approval
FDA Class 3 ·Simplera™ System

Aortic Stent

FDA Pre-Market Approval
FDA Class 3 ·Minima Stent System

Ophthalmic Sealant

FDA Pre-Market Approval
FDA Class 3 ·RESURE SEALANT

Ophthalmic Sealant

FDA Pre-Market Approval
FDA Class 3 ·Resure Sealant

Sensor, Glucose, Invasive, Non-Adjunctive

FDA Pre-Market Approval
FDA Class 3 ·Dexcon G5 Mobile Continuous Glucose Monitoring System

Sensor, Glucose, Invasive, Non-Adjunctive

FDA Pre-Market Approval
FDA Class 3 ·G5 Mobile transmitter Hardware and Firmware, G5 Mobile Continuous Glucose Monitoring System

Aortic Stent

FDA Pre-Market Approval
FDA Class 3 ·Cheatham Platinum (CP) Stent System (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent)

Ophthalmic Sealant

FDA Pre-Market Approval
FDA Class 3 ·ReSure Sealant

Aortic Stent

FDA Pre-Market Approval
FDA Class 3 ·NuDel Delivery System

Ophthalmic Sealant

FDA Pre-Market Approval
FDA Class 3 ·RESURE SEALANT

Sensor, Glucose, Invasive, Non-Adjunctive

FDA Pre-Market Approval
FDA Class 3 ·DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

Sensor, Glucose, Invasive, Non-Adjunctive

FDA Pre-Market Approval
FDA Class 3 ·DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

Aortic Stent

FDA Pre-Market Approval
FDA Class 3 ·NuDEL Delivery System