2,109 results · 21ms · Sources: EU EUDAMED, US FDA

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·THE BELOS, TACHOS ATX, AND LEXOS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR FAMILIES AND CARDIAC AIRBAG

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HeartWare HVAD System

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval
FDA Class 3 ·INTELLANAV STABLEPOINT™ Ablation Catheter & Force Sensing System on the RHYTHMIA HDX™ Mapping System

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·TUPOS LV/ATX, KRONOS LV-T, LUMAX 300/340 FAMILY OF ICDS AND CRT-DS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·TUPOS LV/ATX & KRONOS LV-T CRT-DS & COROX OTW STEROID LV PACING LEAD

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·Tupoa LV/ATX & Kronos LV-T / CRT-D & Corox OWT Steroid LV Pacing Lead

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·Tupos LV/ATX & Kronos LV-T CRT-D and Corox OWT Steroid LV Pacing Lead

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·Tupos LV/ATX & Kronos LV-T CRT-D & Corox OWT Steroid LV Pacing Lead

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·Tupos LV/ATX & Kronos LV-T CRT-D & Corox OWT Steroid LV Pacing Lead

Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

FDA Pre-Market Approval
FDA Class 3 ·FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARAWAVE™ NAV Pulsed Field Ablation C

Wearable Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·LIFEVEST WEARABLE DEFIBRILLATOR

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval
FDA Class 3 ·Rapid fFN for the TLiIQ System

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval
FDA Class 3 ·FETAL FIBRONECTIN ENZYME IMMUNOASSAY KIT (EIK)

Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit

FDA Pre-Market Approval
FDA Class 3 ·AvertD and AvertD Buccal Sample Collection Kit

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval
FDA Class 3 ·Rapid fFN for the TLiIQ System

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval
FDA Class 3 ·Rapid fFN for the TLiIQ System