10,000 results · 32ms · Sources: EU EUDAMED, US FDA

Coronary Drug-Eluting Stent

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

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·EPIC HF/ATLAS HF FAMILY OF CRT-D'S

Ablation Catheter, Renal Denervation

FDA Pre-Market Approval
FDA Class 3 ·Symplicity Spyral™ Renal Denervation System

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·ACCULINK CAROTID STENT SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM

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

FDA Pre-Market Approval
FDA Class 3 ·BIOSENSE WEBSTER CABLES, CELSIUS DS CATHETER, CELSIUS FLTR, EZ STEER NAV DS CATH, NAVISTAR DS CATH, NAVISTAR RMT DS CATH

Kit, Rna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·APTIMA HPV ASSAY

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·MEMORYGEL BREAST IMPLANT

Fluid, Intraocular

FDA Pre-Market Approval
FDA Class 3 ·ADATO SIL-OL 5000 SILICONE OIL

Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

FDA Pre-Market Approval
FDA Class 3 ·FreeStyle Libre 14-day Flash Glucose Monitoring System

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·NAVISTAR/NAVISTAR RMT THERMOCOOL/EZ STEER THERMOCOOL/EZ STEER THERMOCOOL NAV CATHETERS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODEL 304 (ULTRA C-LOOP)

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·cobas® HBV

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·BIOFINITY (COMFILCON A)

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·XIENCE Alpine Everolimus Eluting Coronary Stent System, XIENCE Sierra Everolimus Eluting Coronary Stent System, XIENCE S

Device. Laser Peripheral Angioplasty

FDA Pre-Market Approval
FDA Class 3 ·TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE

Stent, Iliac

FDA Pre-Market Approval
FDA Class 3 ·OMNILINK ELITE PERIPHERAL BALLOON-EXPANDABLE STENT SYSTEM

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP, QuickFlex u, Quartet, and Quartet CRT Leads

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval
FDA Class 3 ·Mentor Saline-Filled and Spectrum Breast Implants

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

FDA Pre-Market Approval
FDA Class 3 ·THERMOCOOL SMARTTOUCH®