10,000 results · 27ms · Sources: EU EUDAMED, US FDA

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·Valiant Thoracic Stent Graft with the Captivia Delivery System

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

FDA Pre-Market Approval
FDA Class 3 ·Light Adjustable Lens, Light Delivery Device

Implanted Brain Stimulator For Epilepsy

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

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·Hancock II Bioprosthesis & Hancock Ultra II Bisprosthesis

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·Cobas HBV

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·MMT-7002 & MMT-7003 GLUCOSE SENSORS

Light Source System, Diagnostic Endoscopic

FDA Pre-Market Approval
FDA Class 3 ·Karl Storz Photodynamic D-Light C (PDD) System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Assurity MRI and Endurity MRI

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

FDA Pre-Market Approval
FDA Class 3 ·Isoflex

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

FDA Pre-Market Approval
FDA Class 3 ·Celsius DS Catheter, NaviStar DS Catheter, NaviStar RMT DS Catheter, EZ Steer Nav DS Catheter, Interface Cables

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM

Analyzer, Diagnostic, Fiber Optic (Colon)

FDA Pre-Market Approval
FDA Class 3 ·WAVSTAT OPTICAL BIOPSY SYTEM

Implant, Corneal, Refractive

FDA Pre-Market Approval
FDA Class 3 ·Raindrop Near Vision Inlay

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval
FDA Class 3 ·AngioSculpt® Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval
FDA Class 3 ·FRONTIER/FRONTIER II FAMILY OF CRT-PS

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval
FDA Class 3 ·IDEAL IMPLANT Structured Breast Implant

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·MEL 90 EXCIMER LASER SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Precision WaveWriter Spinal Cord Stimulator (SCS) System / WaveWriter IPG Test Equipment System

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HeartMate 3™ Left Ventricular Assist System