Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Pacemaker/ICD/CRT non-implanted components

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Pacemaker ICD CRT Non Implanted components.

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

FDA Pre-Market Approval

FDA Class 3 ·PACEMAKER ICD CRT NON IMPLANTED COMPONENTS

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INGEVITY™ non-MRI Lead Passive Fixation, Preformed Atrial J, INGEVITY™ non-MRI Lead Passive Fixation, Ventricular, INGEV

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

FDA Pre-Market Approval

FDA Class 3 ·Celsius Thermocool, EZ Steer Thermocool Non-Nav Bi-Directional, Celsius RMT Thermocool, Thermocool SF Bi-directional non

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

FDA Pre-Market Approval

FDA Class 3 ·THERAPY DUAL 8 CATHETER (NON-IRRIGATED), THERAPY 8MM THERMISTOR ABLATION CATHERER (NON-IRRIGATED) SAFIRE TX CATHETER (NO

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

FDA Pre-Market Approval

FDA Class 3 ·Celsius Thermocool, EZ Steer Thermocool Non-Nav Bi-Directional, Celsius RMT Thermocool, Thermocool SF Bi-directional non

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·THE BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM, THE BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATO

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·Biomet OrthoPak Non-invasive Bone Growth Stimulator System and Biomet SpinalPak Non-invasive Spine Fusion Stimulator Sys

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·THE BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM, THE BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATO

Solution, Removal, Carries

FDA Pre-Market Approval

FDA Class 3 ·CARISOLV NON-INVASIVE DENTAL CARIES REMOVAL SYSTEM

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·VNS THERAPY SYSTEM/NCP/VNS PULSE GENERATORS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INGEVITY MRI LEAD, INGEVITY Non-MRI Lead

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB

Solution, Removal, Carries

FDA Pre-Market Approval

FDA Class 3 ·CARISOLV NON-INVASIVE DENTAL CARIES REMOVAL SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Multi-Application Utility Model, (Non-Implantable Accessories)

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·ActaStim-S Non Invasive Spine Fusion Stimulator