237 results · 29ms · Sources: EU EUDAMED, US FDA

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·CAPSURE FIX NOVUS LEAD, 4076 AND VITATRON CRYSTALLINE LEADS, ICQ09B

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval
FDA Class 3 ·CAPSURE FIX NOVUS MRI SURESCAN LEAD MODELS 5076 AND 4076

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·CAPSURE FIX LEAD, CAPSUREFIX NOVUS, SUREFIX, & VITATRON CRYSTALLINE LEADS

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·Mara Water Vapor Ablation System

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·CAPSURE FIX/NOVUS/SUREFIX/VITATRON PIROUET+/VITATRON CRYSTALINE LEAD DRUG COMBINATIONS

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval
FDA Class 3 ·CapSure Fix Novus Lead; Vitatron Crystalline Active; Fixation Lead, ICF09, ICQ09B

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·SPRINT QUATTRO SINGLE COIL IS-1/DF-1, ACTIVE FIX LEAD

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·MiniMed 630G System with SmartGuard

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval
FDA Class 3 ·MiniMed 670G System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·REVO MRI

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HeartMate 3™ Left Ventricular Assist System (LVAS)

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HeartMate II Left Ventricular Assist System (LVAS)

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·Medtronic Deep Brain Stimulation Therapy System

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

FDA Pre-Market Approval
FDA Class 3 ·ATTUNE TOTAL KNEE SYSTEM

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·CAPSURE FIX NOVUS LEADS/SUREFIX LEAD/VITATRON CRYSTALLINE ACTFIX/VITATRON PIROUET S+

Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

FDA Pre-Market Approval
FDA Class 3 ·XVIVO Perfusion System (XPS) with STEEN Solution Perfusate

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·Praxis Extended RAS Panel

Absorbable Collagen Hemostatic Agent With Thrombin

FDA Pre-Market Approval
FDA Class 3 ·HEMOBLAST Bellows

Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation

FDA Pre-Market Approval
FDA Class 3 ·MicroTransponder Vivistim Paired VNS System (Vivistim System)

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval
FDA Class 3 ·PRISMA TPE 2000 SET