10,000 results · 43ms · Sources: EU EUDAMED, US FDA

Stimulator, Autonomic Nerve, Implanted (Depression)

FDA Pre-Market Approval
FDA Class 3 ·VNS THERAPY SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CARELINK HOME MONITOR,CARDIOSIGHT READER,CARELINK NETWORK DEVICE DATA MANAGEMENT APPLICATION

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

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

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·Stellarex 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter

Intravascular Radiation Delivery System

FDA Pre-Market Approval
FDA Class 3 ·NOVOSTE BETA - CATH SYSTEM

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval
FDA Class 3 ·GORE VIATORR TIPS ENDOPROSTHESIS

Implant, Hearing, Active, Middle Ear, Totally Implanted

FDA Pre-Market Approval
FDA Class 3 ·ESTEEM

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

FDA Pre-Market Approval
FDA Class 3 ·ETI-CORE-IGMK PLUS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·Resolute Onyx Zotarolimus-Eluting Coronary Stent System

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·Pearle Vision Monthly Balance

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval
FDA Class 3 ·MiniMed 780G System

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval
FDA Class 3 ·CORETHERM SYSTEM MICROWAVE THERMOTHERAPY

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·LIFE STENT VASCULAR STENT SYSTEM

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval
FDA Class 3 ·GORE VIABAHN ENDOPROSTHESIS AND ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

Scaffold, Dissection Repair

FDA Pre-Market Approval
FDA Class 3 ·Tack Endovascular System (4F, 1.5-4.5mm)

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Impella RP System

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·Integrity Coronary Stent System

Agent, Injectable, Embolic

FDA Pre-Market Approval
FDA Class 3 ·Apollo Onyx Delivery Microcatheter

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

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT AUSAB

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM