Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Defibtech's Automated External Defibrillator (AED) System

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ICS 3000/EDP 30/CARDIOMESSENGER

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·EDP 30 EXTERNAL DUAL CHAMBER PACEMAKER

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Lifeline/ReviveR DDU-100, Lifeline/ReviveR AUTO DDU-120, Lifeline/ReviveR VIEW DDU-2300, Lifeline/ReviveR VIEW AUTO DDU-

Transcatheter Septal Occluder (Atrial)

FDA Pre-Market Approval

FDA Class 3 ·Occlutech ASD Occluder, Occlutech Pistol Pusher (OPP), Occlutech ASD Occluder Procedure Pack

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

FDA Pre-Market Approval

FDA Class 3 ·INSYNC CRT-D & CONCERTO/CONSULTA CRT-D/MAXIMO II CRT-D & VARIOUS INSYNC FAMILES ODF ICDS

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·ATTUNETM Rotating Platform (RP) Total Knee System, ATTUNETM Cementless Rotating Platform (RP) Total Knee System, ATTUNET

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval

FDA Class 3 ·PLASMAFLO

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 670G System

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·Medtronic MiniMed 670G System

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 670G System

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 670G System

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 670G System

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval

FDA Class 3 ·GAMBRO PLASMAFILTER, PF2000N

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 670G System and MiniMed 770G System

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 670G Insulin Pump

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval

FDA Class 3 ·GAMBRO PRISMAFLEX TPE 2000 SET

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 670G System

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval

FDA Class 3 ·PRISMAFLEX TPE2000 SET

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 670G Insulin Pump