10,000 results · 23ms · Sources: EU EUDAMED, US FDA

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

FDA Pre-Market Approval
FDA Class 3 ·CELSIUS FLTR BI-DIRECTIONAL CATHETER

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODEL SI-11NB UV ABSORBING SILICONE POSTERIOR IOL

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·DEXCOM SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·DEXCOM SEVEN AND SEVEN PLUS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·COOLFLOW TUBING IFU

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Edwards SAPIEN 3™ Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra™ Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra™

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Senza Spiral Cord Stimulation (SCS) System

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·PARADIGM REAL-TIME INSULIN PUMP & PARADIGM REAL-TIME REVEL INSULIN PUMP

Cardiac Ablation Percutaneous Catheter

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

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·CGMS IPRO CONTINUOUS GLOCOSE MONITORING SYSTEM

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·CT LUCIA Intraocular Lens (IOL)

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS(R) BIOPROSTHESIS, MODELS 2625 AND 6625

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HeartMate 3™ Left Ventricular Assist System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MODEL 3038 FUNCTION PACT FOR ASP-II 3003 PROGRAMME

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·PARADIGM REAL-TIME REVEL SYSTEM

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·COBAS HBV TEST

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·ZETA RX/ULTRA RX/OTW

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·FREESTYLE AORTIC ROOT BIOPROSTHESIS