10,000 results · 37ms · Sources: EU EUDAMED, US FDA

System, Esophageal Pacing

FDA Pre-Market Approval
FDA Class 3 ·EXTERNAL PULSE GENERATOR MODEL 2A, TAPSCOPE 500 SERIES ESOPHAGEAL STETHOSCOPE AND PACING CATHETER, TAPSCOPE 210 ESOPHAGR

Generator, Shock-Wave, For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·ORBASONE PAIN RELIEF SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·DEMA FAMILIES & DIVA FAMILIES & SELECTION AFM & C-SERIES & T- SERIES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·350 SERIES/ADAPTA/AT500/ENPULSE/ENRHYTHM/KAPPA 600/700/800/900/RELIA/SENSIA/VERSA/SIGMA

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM

Pulse-Generator, Single Chamber, Single

FDA Pre-Market Approval
FDA Class 3 ·TELECTRONICS PASAR MODEL 4171 PG

Laparoscopic Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval
FDA Class 3 ·ADIANA PERMANENT CONTRACEPTION SYSTEM

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·Y Adaptor/Extender Kit/Sprint Quattro Lead/Subcutaneous Lead

Implantable Pulse Generator, Pacemaker (Non-Crt)

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

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Medtronic CoreValve Evolut R Transcatheter Aortic Valve (TAV)

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

FDA Pre-Market Approval
FDA Class 3 ·CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ICS 3000 IMPLANT MODULE AUTOMATED TEST

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·LUMAX 300/340 DR-T/LUMAX 300/400 VR-T/LUMAX 500/540 DR-T/LUMAX 500/540 VR-T/LUMAX 540 VR-T DX

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ASTRA S DR MRI IPG X3DR01, ASTRA S SR MRI IPG X3SR01, ASTRA XT DR MRI IPG X1DR01, ASTRA XT SR MRI IPG X1SR01

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

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, Implantable, dual chamber, Defibrillator, automatic imp

Glue, Surgical, Arteries

FDA Pre-Market Approval
FDA Class 3 ·BioGlue Surgical Adhesive

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Revo MRI

Intrasaccular Flow Disruption Device

FDA Pre-Market Approval
FDA Class 3 ·Woven EndoBridge (WEB) Aneurysm Embolization System

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/LD and Impella 5.5 with SmartAssist