177 results · 21ms · Sources: EU EUDAMED, US FDA

Diagnostic Low Electric Field

FDA Pre-Market Approval
FDA Class 3 ·MARGINPROBE SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·PRECISION NOVI SPINAL CORD STIMULATOR (SCS) SYSTEM

Implant, Cochlear

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

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·LIBERTE MR & OTW CORONARY STENT SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·NOVASURE IMPENDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·HIRESOLUTION BIONIC EAR SYSTEM

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·EXPRESS2 CORONARY STENT SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·ORSIRO Sirolimus Eluting Coronary Stent System and Orsiro Mission Sirolimus Eluting Coronary Stent System

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·ANGIOSEAL VASCULAR CLOSURE DEVICE

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·CHILLI II COOLED ABLATION CATHETER AND CABLE

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·BLAZER II CARDIAC ABLATION CATHETER AND CABLE

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·HiResolution Bionic Ear System

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·ROTABLATOR ROTATIONAL ANGOPLASTY SYSTEM GUIDEWIRE

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

FDA Pre-Market Approval
FDA Class 3 ·BLAZER II XP CARDIAC ABLATION CATHETER AND CABLE

Stent, Renal

FDA Pre-Market Approval
FDA Class 3 ·Express SD Monorail Premounted Stent System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·PROMUS Element Plus Everolimus-Eluting Stent System/Promus PREMIER Everolimus-Eluting Platinum Chronium Coronary Stent S

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·nGEN™ Pump

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·Blazer II Cardiac Ablation Catheter and Cable

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

FDA Pre-Market Approval
FDA Class 3 ·Blazer Open Irrigated Cardiac Ablation System