10,000 results · 40ms · Sources: EU EUDAMED, US FDA

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·ENDEAVOR & ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ADAPTA/SENSIA/VERSA/AT500/350 SERIES/ENRHYTHM/ENPULSE/KAPPA 700/800/900/RELIA/SIGMA IPGS

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·SynchroMed II (Model 8637) pump

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·Gelfoam (absorbable gelatin)Sterile Sponge

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·CAPSUREFIX NOVUS LEAD, CAPSUREFIX NOVUS LEAD AND CAPSUREFIX NOVUS MRI SURESCAN LEAD, VITATRON CRYSTALLINE ACTIVE FIXATIO

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval
FDA Class 3 ·GYNECARE INTERCEED ABSORBABLE ADHESION BARRIER

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·Y Adapter/Extender Kit, IS-1 Connector Port Pin Plug Kit, Lead Adapter, Sprint Quattro Lead, Subcutaneous Lead, Transven

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·NovaSure Impedance Controlled Endometrial Ablation System

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·SURGICEL® Absorbable Hemostats (SURGICEL® FIBRILLAR™, SURGICEL® SNOW)

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

FDA Pre-Market Approval
FDA Class 3 ·CapSure Epicardial Pacing Lead

System, Laser, Transmyocardial Revascularization

FDA Pre-Market Approval
FDA Class 3 ·TMR Holmium Laser System

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

FDA Pre-Market Approval
FDA Class 3 ·Sentus ProMRI OTW QP S-75, S-85, S-95, L-75, L-95, S-75/49, S-85/49, S-95/49, L-75/49, L-85/49 and Sentus ProMRI OTW QP

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·TRIDYNE VASCULAR SEALANT; TRIDYNE VS Standard Spray Tips; TRIDYNE VS 6 Extended Spray Tip

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·Y Adaptor/Extender Kit, DF-1 Connector Port Pin Plug, HV Splitter/Adaptor Kit, IS-1 Connector Port Pin Plug Kit, Lead Ad

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·MINIMED 530G INSULIN PUMP

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

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC(R) CAPSUREFIX LEAD MODEL 4068,4067,4568

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC LEFT VENTRICULAR PACING LEAD, ATTAIN BIPOLAR OTW MODEL 4194

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·Astra S DR MRI IPG,Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG,