1,575 results · 17ms · Sources: EU EUDAMED, US FDA

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·LASERSCAN LSX EXCIMER LASER SYSTEM

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ACRYSOF TORIC POSTERIOR CHAMBER INTRAOCULAR LENS MODELS SA60T3, SA60T4 AND SA60T5

Implant, Corneal, Refractive

FDA Pre-Market Approval
FDA Class 3 ·INTACS PRESCRIPTION INSERTS/INTACS CORNEAL IMPLANTS

Tricuspid Valve Repair Device, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·TriClip G4 System

Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval
FDA Class 3 ·ATRICURE SYNERGY ABLATION SYSTEM

Neuromodulator For Obesity

FDA Pre-Market Approval
FDA Class 3 ·MAESTRO RECHARGEABLE SYSTEM

Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·ReActiv8 Implantable Neurostimulation System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve system

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·OPTIMIZER Smart, Smart Mini, and Lite Systems

Implant, Hearing, Active, Middle Ear, Partially Implanted

FDA Pre-Market Approval
FDA Class 3 ·VIBRANT D SOUNDBRIDGE SYSTEM

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

FDA Pre-Market Approval
FDA Class 3 ·TMX-3000 THERMATRX OFFICE THERMOTHERAPY SYSTEM

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ACRYSOF TORIC SINGLE-PIECE NATURAL INTRAOCULAR LENS (IOL) MODELS SN60T3, SN60T4 AND SN60T5

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

FDA Pre-Market Approval
FDA Class 3 ·EXABLATE 2100 SYSTEM

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

FDA Pre-Market Approval
FDA Class 3 ·TMX-2000 THERMATRX OFFICE THERMO THERAPY SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·THORATEC PARACORPOREAL VENTRICULAR ASSIST DEVICE (PVAD) SYSTEM AND TLC-II PORTABLE VAD DRIVER

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

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·ACTROS SLR+,KAIROS SL PULSE GENERATORS;SL 60-11,13,15 BP SINGLE PASS PACING LEAD;SWM 1000 B-G01.0.U

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·ACTROS+

Programmer, Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·VERITY ADX XL VDR MODEL 5456I PULSE GENERATOR

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·VERITY ADX XL VDR MODEL 5456I PULSE GENERATOR