10,000 results · 30ms · Sources: EU EUDAMED, US FDA

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·ISOMED IMPLANTABLE FLOW INFUSION PUMP

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·SJM MASTERS SERIES AORTIC VALVED PROSTHESIS WITH VASCUTEK GELWEAVE VALSALVA GRAFT (MODEL VAVGJ-515)

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval
FDA Class 3 ·AMPLATZER SEPTAL OCCLUDER

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC CAPSURE SP NOVUS MODELS 4092 AND 4592 AND VITATRON EXCELLENCE PS & MODELS IMK49B AND IMK 49JB

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·ST JUDE MEDICAL MECHANICAL HEART VALVE

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·LIAISON® XL MUREX HBeAg assay and Control

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval
FDA Class 3 ·InterStim™ Therapy System

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG, Sphera SR MRI IPG

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

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

Leadless Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·Micra AV TPS, Micra TPS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Aurora EV ICD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·EMBLEM MRI S-CD/ EMBLEM S-CD Pulse Generator (PG)

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

FDA Pre-Market Approval
FDA Class 3 ·FINELINE®II EZ Sterox Bipolar IS-1 Atrial/Ventricular, J shaped Lead Stylets Limber, J shaped Lead Stylets Firm, J shape

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·Lutonix Drug Coated Ballon

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·Myocardial Pacing Lead

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·MECHANICAL HEART VALVE SJM(R) MASTER SERIES

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Master Restore™, Itrel™, Synergy™, Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces™, Specify™

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

FDA Pre-Market Approval
FDA Class 3 ·Amplia MRI CRT-D; Amplia MRI Quad CRT-D; Brava CRT-D; Brava CRT-D; Brava Quad CRT-D; Brava Quad CRT-D; Claria MRI CRT-D;

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

FDA Pre-Market Approval
FDA Class 3 ·REVO MRI

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·VITAITY HE MODELS T180 & T182, AND VENTAK PRIZM 2 VR MODEL 1860 AICDS