10,000 results · 38ms · Sources: EU EUDAMED, US FDA

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CADENCE FAMILY OF ICDS

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·HIRESOLUTION BIONIC EAR SYSTEM

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·COBAS HPV TEST

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·TRILOGY PULSE GENERATOR MODELS 235OL, 2250L, AND 2308L

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·EZ Steer Thermocool, EZ Steer Thermocool Bi-Directional, Navistar Thermocool

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·HER OPTION CRYOABLATION THERAPY SYSTEM

Coronary Drug-Eluting Stent

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

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·XACT® Carotid Stent System

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·PERIMOUNT Magna Mitral Ease Pericardial Bioprosthesis

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Sapien 3 Transcatheter Heart Valve

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·HYDROXYPROPYLMETHYLCELLULOSE 2% OCCUCOAT (R)

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·HANCOCK VALVED CONDUIT

Stent, Iliac

FDA Pre-Market Approval
FDA Class 3 ·COMPLETE SE VASCULAR STENT SYSTEM

Stent, Iliac

FDA Pre-Market Approval
FDA Class 3 ·OMNILINK ELITE VASCULAR BALLON-EXPANDABLE STENT SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (RX & OTW), XIENCE NANO EECSS (RX)

Sensor, Glucose, Invasive, Non-Adjunctive

FDA Pre-Market Approval
FDA Class 3 ·G5 Mobile transmitter Hardware and Firmware, G5 Mobile Continuous Glucose Monitoring System

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·NeuroPace RNS System

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

FDA Pre-Market Approval
FDA Class 3 ·Guardant360 CDx

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·CoolFlow Irrigation Tubing Set

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·PARADIGM REAL-TIME REVEL SYSTEM