10,000 results · 34ms · Sources: EU EUDAMED, US FDA

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Lead EV ICD Extravascular - Epsila

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·CAPSUREFIX MRI SURESCAN LEAD, 5086MRI

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval
FDA Class 3 ·THINPREP PROCESSOR,

Leadless Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·Micra Transcatheter Pacing System and Micra AV TPS

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·Selenia Dimensions 3D System High Resolution Tomosynthesis

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Medtronic CoreValve™ Evolut™ R DCS (EnVeo R DCS), Medtronic CoreValve™ Evolut™ PRO DCS (EnVeo PRO DCS), Medtronic Evolut

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Enticos

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC(R) TRANSVENE LEAD SYSTEM

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·TRIDYNE™ Vascular Sealant

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Enticos 4 DR, Enticos 4

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

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

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·DEMA/DIVA IMPLANTABLE PULSE GENERATORS

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·ATTAIN/CONSULTA CRT-P/SYNCRA CRT-P

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·CERVISTA HPV 16/18 COMPONENTS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·Adapta, Versa, Sensia IPG, Adapta, Versa, Sensia IPG, Adapta, Versa, Sensia IPG, Adapta, Versa, Sensia IPG, Adapta, Vers

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

FDA Pre-Market Approval
FDA Class 3 ·TruSight Oncology Comprehensive

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·Sprint Quattro Lead 6935M, Sprint Quattro Lead 6946M, Sprint Quattro Lead 6947, Sprint Quattro Lead 6947M, Sprint Quattr

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·Zenith® Fenestrated AAA Endovascular Graft (ZFEN), Zenith® Flex AAA Endovascular System