42 results · 28ms · Sources: EU EUDAMED, US FDA

Device, Thermal Ablation, Endometrial

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

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·BELOTERO BALANCE, BELOTERO BALANCE (SAMPLE)

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·STARCLOSURE SE VASCULAR CLOSURE SYSTEM

Light Source System, Diagnostic Endoscopic

FDA Pre-Market Approval
FDA Class 3 ·KARL STORZ Photodynamic D-Light C PDD System

Intraocular Lens

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

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·GFX OVER-THE-WIRE CORONARY STENT SYSTEM

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

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval
FDA Class 3 ·INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL

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