37 results · 19ms · Sources: EU EUDAMED, US FDA

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·COMBI 40 + COCHLEAR IMPLANT SYSTEM AND PULSAR COCHLEAR IMPLANT SYSTEM

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

FDA Pre-Market Approval
FDA Class 3 ·Biosense Webster NaviStar Thermocool Catheter

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

FDA Pre-Market Approval
FDA Class 3 ·FoundationOne Liquid CDx

Temporary Non-Roller Type Right Heart Support Blood Pump

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

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·EZE-FIT(TM)

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·MED-EL COCHLEAR IMPLANT SYSTEMS

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·CLARION DEVICE FITTING SOFTWARE (SCLIN)

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

FDA Pre-Market Approval
FDA Class 3 ·POLARx FIT Cryoablation Balloon Catheters

Joint, Temporomandibular, Implant

FDA Pre-Market Approval
FDA Class 3 ·Patient-Fitted TMJ Reconstruction Prosthesis System

Joint, Temporomandibular, Implant

FDA Pre-Market Approval
FDA Class 3 ·PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS SYSTEM

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·HALL EASY-FIT PROSTHETIC HEART VALVE

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·HALL EASY-FIT PROSTHETIC HEART VALVE

Joint, Temporomandibular, Implant

FDA Pre-Market Approval
FDA Class 3 ·Patient-Fitted TMJ Reconstruction Prosthesis System

Joint, Temporomandibular, Implant

FDA Pre-Market Approval
FDA Class 3 ·PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS SYSTEM

Joint, Temporomandibular, Implant

FDA Pre-Market Approval
FDA Class 3 ·Patient-Fitted TMJ Reconstruction Prosthesis System

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

FDA Pre-Market Approval
FDA Class 3 ·POLARx™ Short Tip (ST) Cryoablation Balloon Catheter, POLARx™ Long Tip (LT) Cryoablation Balloon Catheter, POLARx™ FIT S

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC HALL/EASY-FIT PROSTHETIC HEART VALVE

Joint, Temporomandibular, Implant

FDA Pre-Market Approval
FDA Class 3 ·TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis

Joint, Temporomandibular, Implant

FDA Pre-Market Approval
FDA Class 3 ·TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis

Joint, Temporomandibular, Implant

FDA Pre-Market Approval
FDA Class 3 ·TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis