2,589 results · 18ms · Sources: EU EUDAMED, US FDA

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·MEL 90 EXCIMER LASER SYSTEM

Shockwave Intravascular Lithotripsy System

FDA Pre-Market Approval
FDA Class 3 ·Shockwave C2 Intravascular Lithotripsy (IVL) Catheter, VL Generator and Connector Cable Kit, IVL Connector Cable (Replac

Shockwave Intravascular Lithotripsy System

FDA Pre-Market Approval
FDA Class 3 ·Shockwave Intravascular Lithotripsy (IVL) 825 Series Generators

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·MEDITEC MEL 80 EXCIMER LASER SYSTEM

Shockwave Intravascular Lithotripsy System

FDA Pre-Market Approval
FDA Class 3 ·Shockwave C2/C2+ Intravascular Lithotripsy (IVL) Catheter

Shockwave Intravascular Lithotripsy System

FDA Pre-Market Approval
FDA Class 3 ·Shockwave Intravascular System with the C2/C2+ Coronary IVL Catheter

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC(R) MDL 6966, 6936, 6963 TRANSVENE(R) AND MODEL 6939 AND 6999 SUBCUTANEOUS PATCH LEADS.

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·CADET V-105 C AND D AND V-115 C AND D PULSE GENERATORS & SOFTWARE VERSION 4.1 FOR THE PROGRAMMER MDL PR-1500

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·GORE CARDIOFORM ASD Occluder

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·Gore Cardioform ASD Occluder

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·AMPLATZER MUSCULAR VSD OCCLUDER

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·Amplatzer Muscular VSD Occluder

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·CARDIOSEAL SEPTAL OCCLUSION WITH QWIK LOAD

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·GORE® CARDIOFORM Septal Occluder

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·Amplatzer Muscular VSD Occluder

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·GORE CARDIOFORM Septal Occluder

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·AMPLATZER VSD MUSCULAR OCCLUDER

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·AMPLATZER MUSCULAR VSD OCCLUDER

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·AMPLATZER MUSCULAR VSD OCCLUDER

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·AMPLATZER PFO OCCLUDER